BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1923367 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02695
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL MANUFACTURING OR PRODUCT RELATED DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS SUGGESTS THAT THE BALLOON WAS NOT LIKELY DAMAGED PRIOR TO USE. BASED ON THE INFORMATION PROVIDED, THE LESION WAS MILDLY TORTUOUS, MILDLY CALCIFIED AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE EXPERIENCED RUPTURE. IN THIS CASE, AN INTERACTION WITH OTHER DEVICES AND/OR THE TORTUOUS AND CALCIFIED LESION MAY HAVE DAMAGED (SCRATCHED) AND WEAKENED THE BALLOON MATERIAL, SUCH THAT THE BALLOON RUPTURED UPON INFLATION AT 7 ATMOSPHERES (ATM) WHICH IS BELOW THE RATED BURST PRESSURE (RBP) OF 16 ATM. RETURN OF THE VISION STENT DELIVERY SYSTEM MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF A CAUSE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. ALTHOUGH THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY, WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATATION WAS PERFORMED, THE MINI VISION WAS POSITIONED. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 7 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED FOR POST-DILATATION TO COMPLETE THE PROCEDURE. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-CLONMEL 0042041

    Patients

    Seq Age Sex Outcome Treatment
    1