BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2252296 · Received September 17, 2011

    Report

    Report Number
    2024168-2011-06382
    Event Type
    Malfunction
    Date Received
    September 17, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT, AND DEVICE INFORMATION. EVALUATION OF THE STENT DELIVERY SYSTEM (SDS) NOTED BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE BALLOON, CONSISTENT WITH PREPARATION AND A LEAK WHILE IN THE PATIENT ANATOMY. THERE WAS BLOOD IN THE HUB. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THERE WERE MULTIPLE BENDS IN THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING THE PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. AN INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON AND FLUID WAS OBSERVED LEAKING AT A PINHOLE IN THE BALLOON IN THE PROXIMAL TAPER, CONFIRMING THE REPORTED LEAK. THERE WAS A SMALL SCRATCH DISTAL TO THE PINHOLE. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE BALLOON INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE LESION/ANATOMY AND/OR GUIDING CATHETER/GUIDE WIRE. THERE WAS NO REPORT OF ANY LEAK OR DAMAGE TO THE SDS NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE AND THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTY EXPERIENCED DURING THE PROCEDURE. IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED DURING INTERACTIONS WITH THE GUIDING CATHETER. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT RELEVANT TO THIS REPORT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR LEAKS OR BALLOON RUPTURES FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY CALCIFIED, POSTERIOR DESCENDING ARTERY, THE 4.0 MM X 23 MM MULTI-LINK VISION WAS BEING ADVANCED IN THE GUIDE CATHETER WHEN BLOOD RETURN WAS NOTED IN THE INFLATION PORT OF THE CATHETER HUB. IT WAS SUSPECTED THAT THE DEVICE WAS DAMAGED WITH A HOLE AND IT WAS REMOVED FROM THE ANATOMY WITHOUT INCIDENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE. A SECOND 4.0 MM X 23 MM MULTI-LINK VISION WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0100741

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR