BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1214110 · Received October 24, 2008

    Report

    Report Number
    2024168-2008-01012
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 30, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    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 WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS RETURNED ON THE STYLET. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON AND BETWEEN THE MARKERS. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS RETURNED. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE OUTER DIAMETER MEASUREMENTS MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN AND THE ABSENCE OF VISIBLE BLOOD IS CONSISTENT WITH THE REPORTED DISLODGEMENT DURING PREPARATION FOR USE. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING PREP, FORCED SHEATH REMOVAL, INCORRECT SHEATH SIZING, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURING. ANALYSIS OF THE RETURNED DEVICE INDICATES PRESENCE OF CRIMP MARKS ON THE BALLOON THAT WERE BETWEEN THE MARKERS OF THE STILL FOLDED BALLOON, SUGGESTING THAT THE STENT IMPLANT WAS AT LEAST CRIMPED ONTO THE BALLOON AT THE TIME OF MANUFACTURING. THE RETURNED STENT IMPLANT OUTER DIAMETERS AND RETURNED PROTECTIVE SHEATH INNER DIAMETER WERE NOTED TO BE WITHIN MANUFACTURING CRITERIA, INDICATING THAT THERE WAS NO QUALITY ISSUE. BASED ON THE INCIDENT INFO AND RESULTS OF THE RETURNED DEVICE ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A QUALITY ISSUE. THE REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES 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 PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DISLODGED DURING PREPARATION AND REMAINED ON THE MANDREL. THE DEVICE WAS NOT USED IN THE PT. NO ADDITIONAL EVENT OR PT 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 8050831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK