BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1060946 · Received June 13, 2008

    Report

    Report Number
    2024168-2008-00490
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 15, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS THICK CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON. THE STENT IMPLANT WAS DISLODGED FROM THE SDS AND NOT RETURNED. THE BALLOON WAS LOOSELY FOLDED, AS IF PREVIOUSLY INFLATED. THERE WAS NO DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. THE STENT IMPLANT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE STENT IMPLANT NOT RETURNING. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED DEVICE. STENT DISLODGEMENT DURING PREPARATION CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; IMPROPER AND INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, AND HANDLING OF THE STENT DURING PREPARATION. ANALYSIS OF THE SDS CONFIRMED THAT THE STENT WAS DISLODGED FROM THE BALLOON, BUT WAS NOT RETURNED FOR EVALUATION. THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN AND LOOSELY FOLDED BALLOON SUGGESTS THAT, AT SOME POINT, POSITIVE PRESSURE WAS APPLIED TO THE SYSTEM CAUSING THE BALLOON TO EXPAND, PARTIALLY DEPLOYING THE STENT IMPLANT. THIS WOULD CAUSE THE STENT IMPLANT TO BECOME LOOSE, FACILITATING STENT DISLODGEMENT DURING REMOVAL OF THE PROTECTIVE SHEATH. DUE TO THE CONFLICTING INFORMATION RECEIVED WITH THE COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT, A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE STENT DISLODGEMENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE SAME STENT CAME OFF THE DELIVERY SYSTEM DURING PREPARATION AND REMAINED IN THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED ON THE PATIENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 8031331

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK