BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1082850 · Received July 25, 2008

    Report

    Report Number
    2024168-2008-00610
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODE - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE STENT IMPLANT WAS RETURNED ON THE STYLET WITH THE ORANGE PROTECTIVE SHEATH. THE DISTAL END OF THE STENT IMPLANT WAS SLIGHTLY CRUSHED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE BALLOON AND BETWEEN THE MARKERS. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A KINK IN THE SHAFT, 1 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS A BEND IN THE HYPOTUBE, 6 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETER OF THE STENT IMPLANT AND THEY MET MANUFACTURING CRITERIA. PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER OF THE ORANGE PROTECTIVE SHEATH AND THIS MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE ANALYSIS OF THE RETURNED RX VISION SDS FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE. IT SHOULD BE NOTED THAT THE INSPECTIONS PRIOR TO USE SECTION OF THE VISION INSTRUCTIONS FOR USE STATES "PRIOR TO USING THIS DEVICE, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. AFTER REMOVING MANDREL, REMOVE THE PROTECTIVE SHEATH CAREFULLY WITH HOLDING ITS DISTAL END. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED." THE STENT IMPLANT WAS RETURNED ON THE STYLET WITH THE ORANGE PROTECTIVE SHEATH. THE BALLOON WAS LOOSELY FOLDED, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AS IT WAS STILL ENGAGED INTO THE LESION AFTER THE STENT HAD DISLODGED. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE STENT IMPLANT WAS SLIGHTLY CRUSHED AT THE DISTAL END. IF SIGNIFICANT PRESSURE IS INADVERTENTLY APPLIED DURING REMOVAL OF THE PROTECTIVE SHEATH, THE STENT CAN SUSTAIN MECHANICAL DAMAGE AND BECOME DISRUPTED ON THE BALLOON, WHICH MAY ALSO FACILITATE DISLODGEMENT. IN ADDITION, THE ANALYSIS REVEALED THAT THERE WERE CRIMP MARKS ON THE BALLOON AND BETWEEN THE MARKERS, INDICATING THAT THE STENT IMPLANT WAS INITIALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. DIMENSIONAL ANALYSIS OF THE DEVICE ALSO CONFIRMED THAT THE OUTER DIAMETERS OF THE STENT IMPLANT AND INNER DIAMETER OF THE PROTECTIVE SHEATH BOTH MET MANUFACTURING CRITERIA. IN THIS CASE, IT WAS REPORTED THAT THE STENT SUBSEQUENTLY DISLODGED AFTER SOAKING THE DEVICE IN A TRAY OF SALINE. HOWEVER, IT IS UNKNOWN WHETHER THIS COULD HAVE CONTRIBUTED TO THE STENT DISLODGING IF FLUID HAD BEEN INTRODUCED INTO THE SHEATH PRIOR TO REMOVING IT. THEREFORE, BASED ON THE INFORMATION RECEIVED WITH THE COMPLAINT AND THE DEVICE ANALYSIS, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED SENT DISLODGEMENT. ALSO NOTED DURING THE ANALYSIS WAS A KINK IN THE SHAFT DISTAL TO THE GUIDE WIRE EXIT NOTCH, ALONG WITH A BEND IN THE HYPOTUBE. HOWEVER, NO DAMAGES WERE OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE, SUGGESTING THAT THEY MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURE OR POSSIBLY AS A RESULT OF PACKAGING AND SHIPMENT TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT. PRODUCT PERFORMANCE ENGINEERING WILL TREND AND MONITOR THE EXPERIENCE CIRCUMSTANCES. ALL STENTS DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND A SAMPLING OF UNITS ARE DESTRUCTIVELY TESTED TO VERIFY STENT MOVEMENT. 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 AFTER SOAKING THE RX VISION STENT DELIVERY SYSTEM (SDS) IN A TRAY WITH NORMAL SALINE, THE PROTECTIVE SHEATH WAS REMOVED BY HOLDING THE DISTAL END OF THE SHEATH. THE SDS WAS DELIVERED TO THE LESION AND DILATATION WAS PERFORMED HOWEVER, NOT BEING ABLE TO GET PROPER RESULTS, THE SDS WAS REMOVED FROM THE PATIENT. IT WAS THEN NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS FOUND ON THE TRAY. 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 7111931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK