BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1073720 · Received July 1, 2008

    Report

    Report Number
    2024168-2008-00539
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 7, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON HAS LOOSE FOLDS. 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 PROXIMAL SHAFT WAS WAVY DUE TO THE WAY IT WAS RETURNED. THERE WAS NOT OTHER DAMAGE NOTED TO THE SDS. THE TIP SEAL LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED FROM THE MIDDLE OF THE BALLOON DUE TO A PINHOLE 7 MM PROXIMAL TO THE DISTAL MARKER BAND. THERE WERE NO SCRATCHES VISIBLE. THE SDS WAS SENT TO SCANNING ELECTRON MICROSCOPY (SEM) FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND RESULTS OF THE RETURNED DEVICE ANALYSIS. THE ANALYSIS OF THE RETURNED DEVICE NOTED THE PRESENCE OF BLOOD AND CONTRAST IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH THE REPORTED BALLOON RUPTURE. THE STENT IMPLANT WAS NOT RETURNED. SUGGESTING THAT THE STENT WAS DEPLOYED AS REPORTED. FUNCTIONAL ANALYSIS OF THE SDS CONFIRMED THE REPORTED BALLOON RUPTURE. SEM ANALYSIS ALSO CONFIRMED THE NOTED RUPTURE. THE SEM REVEALED A LONGITUDINAL LEAK BETWEEN RINGS FIVE AND SIX OF THE STENT IMPRESSION ON THE BALLOON. THERE WAS SHREDDING NOTED AT AND AWAY FROM THE LEAK. IT WAS CONCLUDED THAT THE BALLOON RUPTURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. FACTORS THAT CAN CONTRIBUTE TO BALLOON PINHOLE RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, MECHANICAL DAMAGE TO THE BALLOON MATERIAL DURING MANUFACTURING, MECHANICAL DAMAGE FROM THE STENT OR MECHANICAL DAMAGE FROM INTERACTION WITH ANOTHER DEVICE OR ANATOMY. IN THIS CASE, IT APPEARS THAT THE DEVICE WAS PREPARED SUCCESSFULLY FOR USE, WHICH SUGGESTS THAT THE PINHOLE MAY NOT HAVE BEEN PRESENT PRIOR TO USE. IT IS POSSIBLE THAT THE DAMAGE TO THE BALLOON MAY HAVE OCCURRED DURING THE ADVANCEMENT OF THE SDS TO THE TARGET LESION, OR THE DAMAGE MAY HAVE BEEN CAUSED BY INTERACTION WITH OTHER DEVICES OR THE STENT IMPLANT. WHILE A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE PINHOLE RUPTURE, AS A PRECAUTIONARY STEP, MANUFACTURING WILL BE NOTIFIED OF THIS INCIDENT. ALTHOUGH, A CONCLUSIVE ROOT CAUSE COULD NOT THE DETERMINED FOR THE REPORTED BALLOON RUPTURE, A FIELD DISCREPANCY NOTICE (FDN) WAS PREVIOUSLY ISSUED TO EVALUATE THE MANUFACTURING PROCESS. THE FDN OWNER HAS BEEN NOTIFIED OF THIS ADDITIONAL INCIDENT. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. 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 PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE RX VISION BALLOON RUPTURED ON THE PROXIMAL END AS IT WAS BEING DEPLOYED. THE STENT WAS DEPLOYED USING ANOTHER BALLOON. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PATIENT INFO IS AVAILABLE. THIS IS BEING FIELD BASED ON THE RETURNED PRODUCT EVALUATION THAT CONFIRMED A BALLOON RUPTURE.

    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 8030331

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK