The Sprint Fidelis Lead is the Other Kind of Class III Device; but all is Not Lost
Posted by
Armand RossettiSeptember 12, 2008 1:35 PMTags:
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The Medtronic Sprint Fidelis lead is the small subset of Class III devices approved under the more stringent FDA PMA process. Therefore, barring any further federal legislation that would revise the current FDA preemption status, Riegel Preemption would apply to the Sprint Fidelis lead (see Riegel Preemption does not include 510(k).
However, FDA regulatory compliance is prerequisite to any preemption. A question arises whether Medtronic followed FDA procedure, every step of the way through the PMA approval process. Did Medtronic act outside the scope of their approved PMA? Did Medtronic strictly comply with the regulations? Those questions would be hard to answer without conducting expensive, comprehensive discovery.
Another important issue may weigh positively for consumers. The Sprint Fidelis did not go through the entire PMA process. PMA submission for the Sprint Fidelis lead was a “supplemental” submission that "piggybacked" on prior PMA approved leads such as the larger diameter Sprint Quatro. Reportedly, the FDA took less than 30 days to assess whether Medtronic’s submission for supplemental approval satisfied a “reasonable assurance of safety and effectiveness.”
Whether Medtronic submitted a supplemental PMA could turn out to be a very important issue, because a 1996 Supreme Court decision ruled that supplemental approval were not covered by the 1976 Medical Devices Act (MDA). Justice Scalia’s recent decision in Riegel did not reverse that 1996 Supreme Court decision.
It remains to be seen whether Medtronic will file summary judgment motions that will elicit oppositions,which argue that the Sprint Fidelis lead is exempt because it did not come under full FDA scrutiny in the PMA process, and that the FDA’s approval rose only to a level that is strikingly similar to the less stringent 510(k) process.
Returning to the issue of strict compliance with FDA's PMA requirements, it seems evident that Medtronic did not file extensive supplemental PMA submissions for Sprint Fidelis PMA approval. In fact the FDA’s website does not list any supplemental PMA for the Sprint Fidelis lead.
According to the FDA’s listing, Medtronic did file supplemental PMA’s for the following approvals: 1) approval for changing the molding vendor and molding process parameters for the is-1 connector sleeve component for sprint lead models 6930, 6931, 6945, 6947, 6948, 6949, and 6944; 2) approval for the addition of a polyurethane overlay for the 6949 and the 6931 leads; 3) approval for the addition of a polyurethane overlay for the 6948 and 6930 leads; 4) a change to the cure process at a component supplier for several types of Sprint lead; and 5) approval for design and manufacturing changes to improve the df-1 leg strength and handling characteristics of sprint Fidelis leads.
While number 5 on the above list looks as if it might be the supplemental that introduced the Sprint Fidelis, it is dated May 15, 2007, or more than two years after the purported January 2005 FDA supplemental approval allegedly issued for the Sprint Fidelis lead. Where is the FDA hiding the original supplemental submission?
Lastly, a history of adverse event reporting concerning the Sprint Fidelis shows why Medtronic was forced to do something about recalling the Sprint Fidelis. Here are the details.
The FDA approved the Sprint Fidelis Lead on 01-13-2005, and the first MAUDE report emerged on 11/10/2005. Since the FDA approved the Sprint Fidelis lead in 2005, Consumers and doctors reported 4001 adverse event cases to the FDA. Here is the breakdown: 66 cases between 01-13-2005 and 01-01-2006; 423 cases between 01-01-2006 and 01-01-2007; then breaking down the year into periods because a search exceeded that 500 document limit for 2007, from 01-01-2007 through 05-01-2007 338 cases appeared on the MAUDE database; from 05-02-2007 through 06-30-2007, there were 260 MAUDE reports; from 07-01-2007 through 12-31-2007, the database contained another 1,429 reports; the Maude database shows 1,484 entries between 01-01-2008 and 09-12-2008. A substantial number of the 4001 reports show “death” as the Event Type.
The breakdown by year is: 66 cases in 2005; 423 cases in 2006; 2,027 cases in 2007, and to date in 2008, 1,484 cases. While these numbers are staggering, adverse events reporting seems to have plateaued, at least for the time being. Of course, the Sprint Fidelis failure rate might accelerate once again as the leads continue to age in situ.
Whether Medtronic did treat the Sprint Fidelis as a minor adjustment to the more robust and harder to implant Sprint Quatro remains to be determined. If Medtronic submitted an "under the radar" type supplemental PMA, Medtronic might not be able to convince a court that it did strictly comply with the FDA's PMA requirements. If the FDA can provide evidence that Medtronic submitted an “original” supplemental PMA for the Sprint Fidelis, questions might still arise concerning Medtronic's stepwise compliance.