BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1220840 · Received October 30, 2008

    Report

    Report Number
    2024168-2008-01045
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 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
    NE, 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 WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST VISIBLE. THE STENT IMPLANT WAS LOCATED ON THE DISTAL SHAFT AND WAS NOT LOOSE. THE DISTAL END OF STENT IMPLANT WAS LOCATED 5 MM PROXIMAL TO THE EDGE OF THE PROXIMAL MARKER BAND. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE NO KINKS NOTED TO THE SDS. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETERS OF STENT IMPLANT. THE OUTER DIAMETER MEASUREMENTS DID NOT MEET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT THE DEVICE WAS NOT USED ON THE PT. PRESENCE OF BLOOD IN THE GUIDE WIRE LUMEN OF THE RETURNED DEVICE IS CONSISTENT WITH THE REPORTED INFO THAT THE SDS WAS AT LEAST LOADED ONTO THE GUIDE WIRE. ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE STENT IMPLANT WAS ON THE DISTAL SHAFT AND WAS NOT LOOSE. THE DISTAL END OF THE STENT WAS LOCATED 5 MM PROXIMAL TO THE EDGE OF THE PROXIMAL MARKER. THERE WERE CRIMP MARKS NOTED ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS, WHICH SUGGEST THAT THE STENT MAY HAVE BEEN REMOUNTED ONTO THE BALLOON SUBSEQUENT TO THE REPORTED DISLODGEMENT. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, INCORRECT SHEATH SIZING, FORCED SHEATH REMOVAL, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE. ANALYSIS OF THE RETURNED DEVICE INDICATES PRESENCE OF CRIMP MARKS BETWEEN THE MARKERS OF THE STILL TIGHTLY FOLDED BALLOON, SUGGESTING THAT THE STENT WAS AT LEAST CRIMPED ONTO THE BALLOON AT THE TIME OF MANUFACTURING. IT IS POSSIBLE THAT THE STENT DISLODGED DURING REMOVAL OF THE PROTECTIVE SHEATH. THE PROTECTIVE SHEATH WAS NOT RETURNED, WHICH WOULD HAVE AIDED IN THE INVESTIGATION. THE NOTED OVER SIZED OUTER DIAMETERS OF THE STENT IMPLANT SUGGEST THAT THE STENT EXPANDED DURING TRAVEL OVER THE BALLOON AS WOULD BE EXPECTED. IT IS ALSO POSSIBLE THAT THE OVER SIZED STENT OUTER DIAMETERS MAY HAVE ORIGINATED FROM THE MANUFACTURING SITE AND CONTRIBUTED TO THE DISLODGEMENT; HOWEVER, THIS IS UNLIKELY CONSIDERING THAT THE STENT OUTER DIAMETERS ARE 100% VERIFIED DURING MANUFACTURING. IT IS UNKNOWN WHEN THE STENT OUTER DIAMETERS BECAME OVERSIZED. ULTIMATELY, THE ROOT CAUSE OF THE STENT DISLODGEMENT IS UNKNOWN, BUT THERE IS NO INDICATION OF A QUALITY ISSUE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS. 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 PRIOR TO LOADING THE VISION ONTO THE GUIDE WIRE, THE STENT DISLODGED. THE DEVICE WAS NOT USED ON 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 7052431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK