BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA BILIARY STENT DELIVERY SYSTEM

    MDR report key: 2051013 · Received April 4, 2011

    Report

    Report Number
    3005325609-2011-00004
    Event Type
    Injury
    Date Received
    April 4, 2011
    Date of Event
    April 27, 2010
    Report Date
    March 11, 2011
    Manufacturer
    IDEV TECHNOLOGIES, INC.
    Product Code
    FGE
    PMA / PMN Number
    K071646
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE CAUSE OF THE EVENT IS UNK. NO INDICATION OF A DEVICE MALFUNCTION. THE CAUSE IS LIKELY THE PT'S DISEASE PROGRESSION.

    Description of Event or Problem · 1

    THIS EVENT WAS OBSERVED BY A (B)(4) MONITOR. THE PT HAD A STUDY DEVICE IN THEIR RIGHT SFA AND NON-STUDY DEVICES IN THEIR LEFT SFA. THE PT WITH PERIPHERAL VASCULAR DISEASE HAD 3 STENTS PLACED IN THE LEFT SFA APPROX 1.5 YEARS PRIOR TO THIS EVENT ((B)(6) 2010). DURING A F/U VISIT, IT WAS OBSERVED THAT THE PT DEVELOPED ABNORMAL ABIS ON THE LEFT, WITH MILD TO MODERATE LEFT LEG CLAUDICATION. GIVEN THE LONG STENTS, WORSENING ABIS, AND SYMPTOMS, IT WAS DECIDED TO PERFORM AN ANGIOGRAPHY AND SUBSEQUENTLY AN ATHERECTOMY DUE TO IN-STENT RESTENOSIS IN ALL 3 STENTS (REFERENCE MDRS 3005325609-2011-00003 AND 3005325609-2011-00005). THERE WERE NO STENT FRACTURES. FINAL ANGIOGRAM DEMONSTRATED WIDELY PATENT STENTS WITH 0-20% STENOSIS, NO EVIDENCE OF DISSECTION AND BRISK TIMI 3 FLOW IN THE DISTAL VESSEL. NO EVIDENCE OF DISTAL EMBOLIZATION. THE PT RETURNED FOR F/U IN (B)(6) 2011. HE COMPLAINED OF PAIN IN HIS LEFT CALF AND RADIATING UPWARDS WHEN WALKING. ABIS WAS .87 AND DROP TO .29 WITH EXERCISE. IN (B)(6) 2011 ATHERECTOMY WAS PERFORMED AND RESULTED IN 0-10% RESIDUAL STENOSIS, NO EVIDENCE OF DISSECTION AND BRISK TIMI3 FLOW IN THE DISTAL VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA BILIARY STENT DELIVERY SYSTEM FGE IDEV TECHNOLOGIES, INC. S-04-100-120-G2 00299061

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization