BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1031563 · Received April 18, 2008

    Report

    Report Number
    2024168-2008-00305
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS FLUID VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. THERE WERE NO KINKS NOTED TO THE DISTAL SHAFT. THE HYPOTUBE SHAFT WAS WAVY DUE TO THE WAY IT WAS ROLLED UP WHEN RETURNED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED RX MINI VISION SDS. IT WAS REPORTED THAT THE STENT IMPLANT DISLODGED IN THE CORONARY ARTERY AND WAS DEPLOYED AT AN UNINTENDED SITE. POTENTIALLY, STENT DISLODGEMENT MAY BE CAUSED BY, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/OR ANATOMY, AND LESION MORPHOLOGY. THE PT ANATOMY WAS NOT DESCRIBED IN THE CASE DETAILS, WHICH COULD HAVE AIDED THE INVESTIGATION. ANALYSIS OF THE SDS CONFIRMED THAT THE STENT WAS DISLODGED FROM THE BALLOON. FLUID WAS VISIBLE IN THE INFLATION LUMEN AND IS CONSISTENT WITH THE PREPARATION OF THE DEVICE. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MFR. ALL ONLINE TESTING FOR THE LOT IN QUESTION MET STENT MOVEMENT CRITERIA, WHICH WOULD INDICATE THE UNIT HAD AN ADEQUATE CRIMP. ALTHOUGH A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE STENT DISLODGEMENT, THERE IS NO INDICATION OF A MFG QUALITY ISSUE. IT WAS ALSO NOTED THAT THE HYPOTUBE SHAFT WAS WAVY DUE TO THE WAY IT WAS ROLLED UP WHEN RETURNED. THE LOT HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORTS ISSUED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED, AND THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT DEPLOYED IN AN UNINTENDED SITE. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DISLODGED IN THE CORONARY ARTERY AND WAS DEPLOYED AT AN UNINTENDED SITE. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7091231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability