BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK 14 PLUS STENT SYSTEM

    MDR report key: 1111542 · Received August 13, 2008

    Report

    Report Number
    3004742046-2008-00193
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED. THE STENT IMPLANT WAS NOT RETURNED. THERE WERE CRIMP MARKS ON THE BALLOON AND BETWEEN THE MARKERS. THE BALLOON WAS SLIGHTLY PRESSURIZED. THERE WAS NO DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE RETURNED BALLOON CATHETER. WATER LEAKED OUT OF A PINHOLE OVER THE PROXIMAL END OF THE DISTAL MARKER. THERE WERE NO SCRATCHES FOUND. THE BALLOON WAS INSPECTED USING SCANNING ELECTRON MICROSCOPY. THE BALLOON FAILURE WAS ATTRIBUTED TO MECHANICAL DAMAGE AT THE DISTAL END OF THE STENT RING. THE DAMAGED END OF THE BALLOON SHOWED A PIN HOLE. IT IS POSSIBLE THAT THE STENT DAMAGED THE BALLOON, EITHER WHEN IT WAS LOADED ONTO THE BALLOON OR DURING THE ATTACHMENT PROCESS (I.E. CRIMPING OR THERMO-GRIP). ONCE THE STENT IS SECURED TO THE BALLOON, THE STENT COULD CONCEAL THE PINHOLE. THE PINHOLE CAN ALSO START AS A MATERIAL ABNORMALITY, FORMING A PINHOLE WHEN THE DEVICE IS PRESSURIZED FOR USE. 100% VISUAL INSPECTION IS DONE FOR BALLOON MATERIAL ABNORMALITIES DURING BALLOON BLOW. ALL BALLOONS ARE 100% INFLATED TO NOMINAL TO MEASURE BALLOON OUTSIDE DIAMETER AND ARE AGAIN 100% INFLATED TO RATED BURST PRESSURE DURING LEAK TESTING. REVIEW OF THE DEVICE LOT HISTORY RECORD FOR LOTS SHIPPED INDICATE THAT THE SAMPLES TESTED DURING RELIABILITY ENGINEERING ON-LINE EXCEEDED THE PRODUCT SPECIFICATION AND NO NON-CONFORMITIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON DID NOT HOLD PRESSURE, BALLOON RUPTURE, PARTIAL DEPLOYMENT, STENT DISLODGEMENT AND MIGRATION. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: STENT UNRETRIEVED IN BODY. IT WAS REPORTED THAT DURING A LEFT MID-RENAL ARTERY STENTING PROCEDURE WHEN THE HERCULINK PLUS BALLOON DID NOT HOLD PRESSURE WHEN INFLATED TO 8 ATMOSPHERES. THIS OCCURRED SEVERAL TIMES. THE BALLOON RUPTURED AND THE PARTIALLY EXPANDED STENT DISLODGED AND MIGRATED DISTALLY IN THE VESSEL. NO STENT RETRIEVAL ATTEMPT WAS MADE AND THE STENT REMAINS IN THE VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER HERCULINK STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK 14 PLUS STENT SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8021851

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention