BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUTLI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1202403 · Received October 16, 2008

    Report

    Report Number
    2024168-2008-00958
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Report Date
    September 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEER WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH NO BLOOD OR CONTRAST VISIBLE. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON, BUT PUSHED DISTAL FROM THE PROXIMAL MARKER BAND FOR A LENGTH OF 9 MM AND THE DISTAL END OF THE STENT IMPLANT WAS 1 MM PROXIMAL TO THE DISTAL END OF THE TIP. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE DISTAL END OF THE STENT IMPLANT WAS FACING DISTALLY. THERE WERE CRIMP MARKS ON THE BALLOON, WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. THE BALLOON WAS TIGHTLY FOLDED. THE PROTECTIVE SHEATH WAS NOT RETURNED. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE PROXIMAL OUTER DIAMETER MEASUREMENTS MET MANUFACTURING CRITERIA. THE DISTAL OUTER DIAMETER AND MIDDLE OUTER DIAMETER MEASUREMENTS DID NOT MEET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED RX VISION STENT DELIVERY SYSTEM (SDS). IT WAS REPORTED THAT THE STENT WAS OBSERVED TO BE CRIMPED ON THE BALLOON, BUT PUSHED DISTALLY AND NOT IN THE CORRECT POSITION. STENT MOVEMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING BUT NOT LIMITED TO, INADEQUATE CRIMPING DURING MANUFACTURING INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL. THE ANALYSIS OF THE SDS WAS ABLE TO CONFIRM THAT THE STENT IMPLANT WAS STATIONARY ON THE BALLOON, BUT WAS PUSHED DISTALLY FROM THE PROXIMAL MARKER BAND FOR A LENGTH OF 9 MM AND THE DISTAL END OF THE STENT WAS LOCATED 1 MM PROXIMAL TO THE DISTAL END OF THE TIP. IN THIS INSTANCE, THE ANALYSIS REVEALED CRIMP MARKS EVIDENT ON THE BALLOON WHERE THE STENT HAD BEEN BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. IN ADDITION, DIMENSIONAL ANALYSIS ALSO INDICATED THAT THE OUTER DIAMETER OF THE PROXIMAL END OF THE STENT MET MANUFACTURING CRITERIA; HOWEVER, THE MIDDLE AND DISTAL DIMENSIONS WERE ABOVE THE ACCEPTED MANUFACTURING SPECIFICATION. THIS MAY HAVE BEEN A RESULT OF THE STENT MOVEMENT, AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON. THE PROTECTIVE SHEATH WAS ALSO NOT RETURNED IN THIS CASE, WHICH MAY HAVE AIDED THE INVESTIGATION. UNFORTUNATELY, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE RETURNED DEVICE ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED DISCREPANCY COULD NOT BE DETERMINED. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A MANUFACTURING RELATED ISSUE, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. ADDITIONALLY, A SAMPLING OF UNITS IS SUBJECTED TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT AND ALL ON-LINE INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. IN ADDITION, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED WITH THIS PART AND LOT NUMBER COMBINATION, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY ISSUES. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PATIENT INJURY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT AFTER UNPACKING THE DEVICE, IT WAS NOTICED THAT THE STENT WAS CRIMPED ON THE BALLOON, BUT NOT IN THE CORRECT POSITION. THE STENT WAS CRIMPED, BUT HAD SHIFTED IN A DISTAL POSITION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THIS IS BEING REPORTED BASED ON THE RETURNED PRODUCT ANALYSIS, THAT REVEALED THE STENT HAD PARTIALLY DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUTLI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8021331

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK