BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1220839 · Received October 30, 2008

    Report

    Report Number
    2024168-2008-01042
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. 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 AND BALLOON. THE STENT IMPLANT WAS LOOSELY FOLDED, AS IF PREVIOUSLY INFLATED. THERE WERE LIGHT CRIMP MARKS VISIBLE BETWEEN THE MARKERS. THERE WAS A KINK IN THE INNER AND OUTER MEMBER 8.3 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS NO DAMAGE NOTED TO THE TIP. THERE WAS A KINK IN THE HYPOTUBE 1MM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE TIP SEAL LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE STENT IMPLANT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE STENT IMPLANT NOT RETURNING. PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT THE INABILITY TO CROSS A LESION CAN ALSO BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, DEVICE SIZE SELECTION, AND ACCESSORY DEVICE SUPPORT. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY FOLDED BALLOON, SUGGESTING THAT, AT SOME POINT, POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM, FORCING THE BALLOON TO SLIGHTLY EXPAND AND PARTIALLY DEPLOY THE STENT. THIS WOULD ALSO CAUSE THE STENT TO BECOME LOOSE, FACILITATING STENT DISLODGEMENT DURING REMOVAL OF THE PROTECTIVE SHEATH. STENT DISLODGEMENT MAY BE INFLUENCED BY NUMEROUS 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, AND INTERACTION WITH THE LESION AND / OR ACCESSORY DEVICES. NO CONCLUSIVE ROOT CAUSE FOR THE FAILURE TO CROSS COULD BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT. 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 PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DID NOT CROSS LESION. NO ADDITIONAL EVENT OR PT INFO AVAILABLE. THIS IS BEING REPORTED BASED ON THE RETURNED PRODUCT EVAL THAT REVEALED THE STENT WAS DISLODGED.

    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 7060131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK