BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1013265 · Received March 14, 2008

    Report

    Report Number
    2024168-2008-00185
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROD PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE VAL OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITH BLOOD VISIBLE IN THE INFLATION LUMEN, THE GUIDE WIRE LUMEN, AND THE BALLOON. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON WAS LOOSELY FOLDED. THERE WERE THREE KINKS IN THE SHAFT 6.6 CM AND 12 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH AND 1MM PROXIMAL TO THE GUIDEWIRE EXIT NOTCH. THERE WAS NO OTHER VISIBLE DAMAGE NOTED TO THE SDS. THE USED GUIDE WIRE WAS NOT RETURNED. DELTRONIC PIN GAUGES WERE USED TO MEASURE THE TIP INNER DIAMETER PAST THE PROXIMAL SEAL AND THE GUIDE WIRE EXIT NOTCH. THE INNER DIAMETERS MET MFG CRITERIA. A NEW GUIDE WIRE WAS BACKLOADED THROUGH THE SDS WITH NO RESISTANCE NOTED. A NEW INDEFLATOR, FILLED WITH WATER WAS USED IN AN ATTEMPT TO INFLATE THE SDS, WHEN FLUID LEAKED OUT OF A PINHOLE OVER THE PROXIMAL BALLOON MARKER. THERE WERE NO SCRATCHES VISIBLE. THE SDS WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PROD PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVAL OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT ANOTHER CO'S GUIDE WIRE WAS INSERTED AND PRE-DILATATION WAS PERFORMED WITH A BALLOON CATHETER. THEN, THE VISION WAS DEPLOYED AT THE LESION. POST-DILATION WAS PERFORMED JUST AFTER THE STENT WAS DEPLOYED (IT WAS NOT REMOVED OUTSIDE). HOWEVER, THE PRESSURE DID NOT GO ABOVE 14 ATM, SO IT WAS THOUGHT THAT THE BALLOON RUPTURED. WHEN ATTEMPTING TO REMOVE THE STENT DELIVERY SYS (SDS) FROM THE PT, IT STRUCK THE GUIDE WIRE AND BOTH THE GUIDEWIRE AND THE VISION WERE REMOVED TOGETHER. THE GUIDE WIRE WAS SEPARATED FROM THE VISION OUTSIDE THE PT'S BODY, AND THE GUIDE WIRE WAS DISCARDED. NO ADD'L 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 7111531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DIL CAT: RYUJIN| GUIDE WIRE: NEO'S RINATO