BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 3890917 · Received June 24, 2014

    Report

    Report Number
    2024168-2014-04025
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THOUGH THE DEVICE IS NOT APPROVED FOR SALE IN THE U.S., IT USES A DELIVERY SYSTEM WHICH IS SIMILAR TO A DEVICE SOLD IN THE U.S. EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND THE DISTAL SHAFT WITH IMPLANT WAS NOTED TO BE SEPARATED AND NOT RETURNED. THE REPORTED MISSING COMPONENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON THE ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR MISSING COMPONENT OR SHAFT SEPARATION REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 2.5 X 28 MM DEVICE WAS OPENED FOR USE AND IT WAS NOTICED THAT THERE WAS NO IMPLANT ON THE DELIVERY SYSTEM. NO RESISTANCE WAS FELT DURING REMOVAL OF THE DEVICE FROM THE SHEATH. THE SHEATH WAS CHECKED TO ENSURE THE IMPLANT WAS NOT INSIDE THE SHEATH. THE DEVICE WAS NOT USED IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED DEVICE NOTED THE DISTAL SHAFT WAS SEPARATED AND THE DISTAL PORTION INCLUDING THE IMPLANT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367263 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3111961

    Patients

    Seq Age Sex Outcome Treatment
    1