BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 2830624 · Received November 13, 2012

    Report

    Report Number
    2024168-2012-07154
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. REVIEWS OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THOUGH THE DEVICE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM 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. THE PRODUCT CODE TYPE AND THE PMA# IS BASED ON THE PREDICATE DEVICE (XIENCE V STENT SYSTEM) THAT IS DETERMINED TO BE SAME AND SIMILAR TO THE DELIVERY SYSTEM OF THIS DEVICE. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE ABSORB SCAFFOLD WAS IMPLANTED, THERE WAS DIFFICULTY REMOVING THE DELIVERY SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1