BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 4203737 · Received October 27, 2014

    Report

    Report Number
    2024168-2014-07009
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BROKEN IMPLANT WAS NOT CONFIRMED; HOWEVER, THE BALLOON/SHAFT WAS SEPARATED. THE REPORTED DIFFICULTY REMOVING THE PROTECTIVE SHEATHS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED 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 THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. THE PRODUCT CODE LISTED AND THE PMA# LISTED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE, WHEN TRYING TO REMOVE THE PROTECTIVE SHEATH, THE IMPLANT BROKE. THE PHYSICIAN STATED THAT THE SHEATH WAS STUCK ON THE IMPLANT. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER UNKNOWN DEVICE WAS THEN SUCCESSFULLY USED TO FINISH THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURNED DEVICE EVALUATION REVEALED THAT THE BALLOON AND DISTAL END OF THE INNER MEMBER WERE SEPARATED AND RETURNED IN THE PROTECTIVE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683950 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4030761

    Patients

    Seq Age Sex Outcome Treatment
    1