BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 3241031 · Received July 22, 2013

    Report

    Report Number
    2024168-2013-04589
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 27, 2013
    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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SEPARATION OF THE SHAFT WAS CONFIRMED. THE REPORTED DIFFICULTY REMOVING THE PROTECTIVE SHEATHS COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON THE VISUAL AND DIMENSIONAL 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 REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: PRIOR TO REMOVAL OF THE PACKAGING MANDREL, CAREFULLY SLIDE THE YELLOW OUTER SHEATH TOWARDS THE DISTAL FLARE, OPENING THE LONGITUDINAL SPLIT ON THE INNER SHEATH. REMOVE BOTH SHEATH PIECES AND STYLET FROM THE DELIVERY SYSTEM. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE YELLOW PROTECTIVE SHEATH FROM THE DEVICE, IT APPEARED TO BE STUCK. THE SHEATH WAS PULLED WITH FORCE, CAUSING THE CATHETER SHAFT TO SEPARATE. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER DEVICE WAS USED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341266 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3031261

    Patients

    Seq Age Sex Outcome Treatment
    1