BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1013293 · Received March 14, 2008

    Report

    Report Number
    2024168-2008-00182
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS LOOSE ON THE SHAFT PROXIMAL TO THE BALLOON. THE FIRST ROW OF PROXIMAL STRUTS WAS FLARED AND SLIGHTLY SMASHED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS PARTIALLY INFLATED. THERE WERE FAINT CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THERE WAS A KINK IN THE HYPOTUBE 17.5 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS A KINK IN THE HYPOTUBE 1MM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE MEASUREMENTS DID NOT MEET MANUFACTURING CRITERIA. ALL OF THE MEASUREMENTS WERE OVERSIZED. THE PROXIMAL MEASUREMENTS WERE TAKEN ONE ROW DISTAL TO THE DAMAGED STRUTS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED SDS. ALTHOUGH NO DAMAGE WAS REPORTED DURING THE INSPECTION PRIOR TO USE, THE PROXIMAL STENT STRUTS WERE NOTED AS FLARED. DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE DEVICE. THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN AND THE PARTIALLY INFLATED BALLOON IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS PREPARED FOR USE AND PRESSURIZED. FAINT CRIMP MARKS WERE VISIBLE ON THE BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. CRIMP MARKS BECOME LESS DEFINED ON THE BALLOON AFTER INFLATION. THE STENT OUTER DIAMETER DIMENSION WAS OUTSIDE OF THE ACCEPTED MANUFACTURING SPECIFICATION; HOWEVER, BECAUSE STENT OUTER DIAMETER IS VERIFIED 100% AT THE TIME OF MANUFACTURE AND UNITS IN THIS LOT WERE ALL WELL WITHIN THE REQUIRED SPECIFICATION. THIS MOST LIKELY OCCURRED AT THE TIME OF DISLODGEMENT AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON. STENT DISLODGEMENT MAY BE CAUSED BY, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/OR ANATOMY, AND LESION MORPHOLOGY. ALL ONLINE TESTING FOR THE LOT IN QUESTION MET STENT MOVEMENT CRITERIA, WHICH WOULD INDICATE THE UNIT HAD AN ADEQUATE CRIMP. THE REPORTED HEAVILY TORTUOUS ANATOMY AND HEAVILY CALCIFIED LESION LIKELY CONTRIBUTED TO THE STENT DISLODGEMENT. IN ADDITION, THE STENT WAS SLIGHTLY SMASHED AND TWO KINKS WERE NOTED IN THE HYPOTUBE. THIS DAMAGE WAS NOT REPORTED AND MAY HAVE OCCURRED DURING THE PACKING OF THE DEVICE FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. 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 VESSEL TO BE TREATED WAS THE PDA IN A VERY TORTUOUS AND CALCIFIED ARTERY. THE LESION WAS PRE-DILATED AND THE RX VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. THE SYSTEM WAS INFLATED; HOWEVER, AFTER DEFLATING THE BALLOON IT WAS NOTICED THAT THE STENT WAS NOT IN THE ARTERY. THE DEVICE WAS REMOVED VERY SLOWLY AND FOUND THAT THE STENT WAS UNDEPLOYED ON THE SHAFT OF THE SDS. IT IS POSSIBLE THAT THE STENT COULD HAVE SLIPPED PROXIMALLY WHILE BEING ADVANCED THROUGH THE VERY CALCIFIED ARTERY, DESPITE THE FACT THAT THE LESION HAD BEEN PRE-DILATED. NO ADD'L 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 8010531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK