BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1082764 · Received July 24, 2008

    Report

    Report Number
    2024168-2008-00600
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE LOOSE STENT. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE IN THE BALLOON AND IN THE INFLATION LUMEN. THERE WAS NO CONTRAST VISIBLE. THE BALLOON WAS LOOSELY FOLDED. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE, 21.5 CM, 48.5 CM, 52 CM, 61 CM AND 92 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON. THERE WAS A PINHOLE ON THE BALLOON, 1 MM DISTAL TO THE DISTAL END OF THE BALLOON PROXIMAL MARKER. THERE WERE SCRATCHES ABOVE THE PINHOLE ON THE BALLOON. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND RESULT OF THE RETURNED DEVICE ANALYSIS. POTENTIAL CAUSES OF BALLOON PINHOLE RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, MECHANICAL DAMAGE FROM STENT, MECHANICAL DAMAGE FROM BALLOON MARKERS, MECHANICAL DAMAGE FROM INTERACTION WITH ANOTHER DEVICE OR ANATOMY OR STENT CRIMPED TOO LOW. IN THIS INSTANCE, IT APPEARS THAT THE DEVICE WAS PREPARED SUCCESSFULLY FOR USE, WHICH SUGGESTS THAT THE PINHOLE MAY NOT HAVE BEEN PRESENT PRIOR TO USE. THE DAMAGE TO THE BALLOON MAY HAVE OCCURRED DURING THE ADVANCEMENT OF THE SDS TO THE TARGET LESION CONSIDERING THAT SCRATCHES WERE NOTED ABOVE THE PINHOLE ON THE BALLOON, OR THE DAMAGE MAY HAVE BEEN CAUSED BY INTERACTION WITH OTHER DEVICES OR THE STENT IMPLANT. ULTIMATELY, THE ROOT CAUSE WAS UNDETERMINED. HOWEVER, THERE IS NO INDICATION OF A QUALITY ISSUE. THE NOTED BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING WAS NOT REPORTED IN THE INCIDENT AND MAY HAVE OCCURRED DURING MANIPULATION OF THE DEVICE INSIDE THE ANATOMY OR DURING PACKING OF THE DEVICE FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO THE REPORTED BALLOON RUPTURE. AS A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED, AND THERE IS NO INDICATION OF A QUALITY ISSUE, NO CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED WITH THIS PART NUMBER LOT NUMBER COMBINATION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE ML VISION STENT WAS IMPLANTED. DURING INFLATION, A SMALL AMOUNT OF CONTRAST MEDIUM WAS SEEN. IT WAS NOTICED THAT THE INFLATION DEVICE WAS LOSING PRESSURE SLOWLY. THERE WAS PROXIMAL BALLOON LEAKAGE DURING IMPLANTATION. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8050831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK