BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1012704 · Received March 12, 2008

    Report

    Report Number
    2024168-2008-00176
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 11, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE DISLODGED STENT. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS DISLODGED PROXIMAL TO THE BALLOON ON THE SHAFT. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS. THE INNER MEMBER WAS BUNCHED PROXIMAL AND DISTAL TO THE DISTAL BALLOON MARKER FOR A LENGTH OF 5MM. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. A LASER MICROMETER WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETER AND THEY DID NOT MEET MANUFACTURING CRITERIA. ALL MEASUREMENTS WERE OVERSIZED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED SDS. IT WAS REPORTED THAT THE STENT IMPLANT DISLODGED ONTO THE SHAFT AFTER THE GUIDE WIRE WAS INSERTED INTO THE SDS. NO DAMAGE WAS NOTED DURING THE INSPECTION PRIOR TO USE. ANALYSIS OF THE SDS CONFIRMED THAT THE STENT HAD DISLODGED FROM THE BALLOON AND WAS LOCATED ON THE SHAFT. THE BALLOON WAS STILL TIGHTLY FOLDED; HOWEVER, THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN SUGGESTS THAT, AT SOME POINT, POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM CAUSING THE BALLOON TO SLIGHTLY EXPAND, PARTIALLY DEPLOYING THE STENT. THIS WOULD CAUSE THE STENT TO BECOME LOOSE AND THE OUTER DIAMETERS TO BE OUT OF SPECIFICATION, AS NOTED DURING THE ANALYSIS. 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. ALL ONLINE TESTING FOR THE LOT IN QUESTION MET STENT MOVEMENT CRITERIA AND THE RELEASE TESTING DATA WAS ALSO REVIEWED. ALL SAMPLES FROM THIS LOT PASSED TESTING FOR STENT PLACEMENT, CRIMPED STENT OUTER DIAMETER, AND STENT MOVEMENT, INDICATING THE UNITS HAD AN ADEQUATE CRIMP. OTHER POTENTIAL CAUSES FOR THIS TYPE OF EVENT AS OBSERVED IN PAST INCIDENTS MAY INCLUDE NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL. UNFORTUNATELY, NONE OF THE INFO GATHERED SUGGESTS ANY OF THESE CAUSES ARE THE MOST LIKELY CAUSE. ADDITIONALLY, BLOOD WAS VISIBLE IN THE GUIDE WIRE LUMEN, WHICH INDICATES THAT THE GUIDE WIRE HAD BEEN INSERTED INTO THE SDS AS REPORTED; HOWEVER, THE INNER MEMBER WAS FOUND BUNCHED AT THE DISTAL BALLOON MARKER. THIS OBSERVATION, ALTHOUGH NOT REPORTED, MOST LIKELY RESULTED FROM THE ATTEMPT TO INSERT AND/OR THEN REMOVE THE GUIDE WIRE WHILE THERE WAS RESISTANCE BETWEEN THE DEVICES. THE DESIGN OF LOW PROFILE DEVICES HAS RESULTED IN MINIMAL CLEARANCE BETWEEN THE GUIDE WIRE AND THE CATHETER. COAGULATION OF BLOOD OR CONTRAST IN THE LUMEN OF THE CATHETER OR ON THE GUIDE WIRE CAN ALSO BE A FACTOR IN REDUCING CLEARANCE. THE USED GUIDE WIRE WAS NOT RETURNED FOR EVAL, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. IN THIS CASE, WITH THE INFO PROVIDED AND ANALYSIS OF THE SDS, A CONCLUSIVE ROOT CAUSE, THE STENT DISLODGEMENT CANNOT BE DETERMINED; HOWEVER, THERE DOES NOT APPEAR TO BE A PRODUCT QUALITY ISSUE. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED WITH THIS VISION PART AND LOT NUMBER COMBINATION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: DISLODGED STENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: DISLODGED STENT. IT WAS REPORTED THAT THE STENT WAS NOTED TO HAVE SHIFTED ONTO THE SHAFT AFTER IT HAD BEEN LOADED ONTO THE GUIDE WIRE, PRIOR TO USE IN THE PATIENT. NO ADD'L EVENT OR PROBLEM INFO 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 7080131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK