BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1063829 · Received June 19, 2008

    Report

    Report Number
    2024168-2008-00503
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 20, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE COULD NOT 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 CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS DISLODGED FROM THE SDS AND RETURNED INSIDE THE PROTECTIVE SHEATH. THE STENT IMPLANT WAS SMASHED TO ENTIRE LENGTH. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS LOOSELY FOLDED AS IF PREVIOUSLY INFLATED. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS. THERE WERE TWO KINKS IN THE HYPOTUBE 35 CM AND 81.3 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE STENT IMPLANT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE STENT BEING SMASHED. THE INNER DIAMETER OF THE ORANGE PROTECTIVE SHEATH WAS .055". PRODUCT PERFORMANCE ENGINEERING DETERMINED STENT DISLODGEMENT PRIOR TO USE CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION. ANALYSIS OF THE SDS FOUND CONFLICTING INFORMATION RECEIVE WITH THE COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT. CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY FOLDED BALLOON, ARE CONSISTENT WITH THE DEVICE BEING PREPARED FOR USE AND PRESSURIZED. IT WAS CONFIRMED THAT THE STENT HAD DISLODGED FROM THE BALLOON AND WAS RETURNED INSIDE THE PROTECTIVE SHEATH. THERE WAS NO DAMAGE TO THE PROTECTIVE SHEATH AND THE INNER DIAMETER MET MANUFACTURING CRITERIA; HOWEVER, THE STENT IMPLANT WAS SMASHED THE ENTIRE LENGTH, WHICH SUGGESTS THAT THE STENT DISLODGEMENT MAY HAVE OCCURRED OUTSIDE THE SHEATH AND WAS DAMAGED AS IT WAS BEING PUSHED BACK IN THE SHEATH, ALTHOUGH THIS CANNOT BE CONFIRMED. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. ALL ONLINE TESTING FOR THE LOT IN QUESTION MET STENT MOVEMENT CRITERIA, WHICH WOULD INDICATE THE UNIT HAD AN ADEQUATE CRIMP. THERE IS NO INDICATION OF A MANUFACTURING QUALITY ISSUE; HOWEVER, DUE TO THE CONFLICTING INFORMATION RECEIVED WITH THE COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT, A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT CANNOT BE DETERMINED. TWO KINKS IN THE HYPOTUBE WERE NOTED, WHICH WERE NOT REPORTED IN THE INCIDENT DETAILS AND MAY HAVE OCCURRED DURING THE PACKING OF THE DEVICE FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR TO HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DDI 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 HAD CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT WHILE PREPARING TO LOAD THE VISION OVER THE GUIDE WIRE, IT WAS DISCOVERED THAT THE STENT HAD DISLODGED AND REMAINED ON THE TABLE, ON THE MANDREL AND IN THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED IN 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 8010331

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK