BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 1101685 · Received August 7, 2008

    Report

    Report Number
    3004742046-2008-00187
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K060817
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE OMNILINK STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH THE BALLOON LOOSELY FOLDED. THE BALLOON FOLDS WERE NOT AS TIGHT AS A BALLOON HAVING BEEN REMOVED FROM THE PROTECTIVE SHEATH. THE SLIGHT LOOSENESS SUGGESTS THE BALLOON MAY NOT HAVE BEEN INFLATED OR INFLATED FULLY. THERE WERE CRIMP MARKS ON THE BALLOON, WHICH WERE VERY PRONOUNCED AND DETAILED, SUGGESTING THE BALLOON HAD NOT BEEN FULLY INFLATED. DURING PRODUCTION, DESTRUCTIVE INFLATION OF A CRIMPED, STENTED BALLOON TO RATED BURST PRESSURE REDUCES THE VISIBILITY OF THE CRIMP MARKS SUBSTANTIALLY. THERE WAS NO DAMAGE NOTED TO THE OMNILINK .035" CATHETER. THE PROTECTIVE SHEATH WAS NOT RETURNED. A NEW INDEFLATOR, FILLED WITH RENOGRAFIN 60 DILUTED 1:1 WITH WATER, WAS USED TO PRESSURIZE THE BALLOON TO NOMINAL PRESSURE AND MEASURE THE BALLOON'S MAXIMUM OUTER DIAMETER. THE BALLOON MEASUREMENT, DEFLATION AND INFLATION TIMES WERE WITHIN MANUFACTURING SPECIFICATIONS. NO MANUFACTURING ISSUES WERE OBSERVED. THE REPORTED INCIDENT SUGGESTS THAT THE STENT DISLODGEMENT MAY HAVE BEEN DUE TO THE HEAVY VESSEL CALCIFICATION. NO SCRATCHES WERE OBSERVED ON THE BALLOON. A ROOT CAUSE COULD NOT BE DETERMINED FOR THE STENT DISLODGEMENT. ALL OMNILINK STENT DELIVERY SYSTEMS ARE 100% INSPECTED ON-LINE IN AN EFFORT TO ENSURE THAT EACH STENT IS SECURELY CRIMPED ONTO ITS BALLOON. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT DISLODGEMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: STENT IMPLANTED IN UNINTENDED SITE. IT WAS REPORTED THAT DURING A RIGHT COMMON FEMORAL ARTERY STENTING PROCEDURE, THE OMNILINK STENT DELIVERY SYSTEM (SDS) WAS POSITIONED IN THE TARGET LESION AFTER MULTIPLE PRE-DILATATIONS WERE PERFORMED. THE BALLOON WAS INFLATED AND THE STENT WAS THOUGHT TO HAVE BEEN DEPLOYED IN THE LESION. THE SDS WAS REMOVED, ALTHOUGH RESISTANCE WAS FELT WHILE PULLING THE SDS INTO THE 6F SHORT INTRODUCER SHEATH. THE UNDEPLOYED STENT WAS THEN OBSERVED ON THE WIRE, AT THE DISTAL END OF THE SHEATH, IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT'S UNKNOWN WHEN THE STENT DISLODGED FROM THE BALLOON. THE UNDEPLOYED STENT WAS EXPANDED AND IMPLANTED IN THE UNINTENDED SITE IN THE SFA USING A NON-ABBOTT BALLOON. ACCORDING TO THE PHYSICIAN, THE STENT DISLODGEMENT WAS A RESULT OF SEVERE VESSEL CALCIFICATION. THERE WAS NO ADVERSE PATIENT SEQUELA. THE TARGET LESION WAS LEFT UNSTENTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .035 STENT DELIVERY SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8060451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 5X40 ADMIRAL EXTREME DILATATION BALLOON| 6 F SHORT SHEATH