BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 1645701 · Received March 12, 2010

    Report

    Report Number
    2024168-2010-00480
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 17, 2010
    Report Date
    February 17, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 3.5 X 18 MM MULTI-LINK 8 (PART # 1012168-18, LOT #9121561) IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. EVALUATION SUMMARY: DIFFICULTY TO DEFLATE CAN BE AFFECTED BY, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE WHEN USING THE PRODUCT AND ACCESSORY DEVICE SUPPORT, UNEVENLY TRIMMED HYPO-TUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED AND BLOCKING THE FLOW OF CONTRAST IN OR OUT OF THE BALLOON, AND/OR CONTAMINATION IN THE INFLATION LUMEN AND INNER DIAMETER OF THE SHAFT. TO HELP ENSURE THAT THE REPORTED DIFFICULTIES ARE NOT DUE TO MANUFACTURING, THE PRODUCTS ARE 100% INSPECTED FOR DAMAGE AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER INFLATION AND DEFLATION. POSSIBLE CAUSES FOR DIFFICULTY IN REMOVING SDS POST DEPLOYMENT MAY INCLUDE: INTERACTION OF THE BALLOON WITH THE STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED TO THE VESSEL WALL, THE BALLOON NOT BEING FULLY DEFLATED PRIOR TO ATTEMPTING TO REMOVE THE BALLOON FROM THE IMPLANTED STENT, POOR BALLOON REFOLD OR THE BALLOON GETTING CAUGHT WITHIN THE STENT STRUTS POST DEPLOYMENT. TO HELP ENSURE THIS DIFFICULTY IS NOT RELATED TO A PRODUCT QUALITY DEFICIENCY, THE BALLOON IS CHECKED FOR PROPER FOLD CONFIGURATION AND DAMAGE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT AND BALLOON DEFLATION. IN THIS CASE, IT IS LIKELY THAT REPORTED DIFFICULTY TO DEFLATE CONTRIBUTED TO THE REPORTED DIFFICULTY TO REMOVE. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS (NCMR) FOR THIS LOT. IN THIS CASE, ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEFLATE COULD NOT BE DETERMINED, THE REPORTED DIFFICULTY TO REMOVE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: FAILURE TO DEFLATE. TIME OF DEVICE MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING THE PROCEDURE, A RX MULTI-LINK STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND A SECOND RX MULTI-LINK IN THE MID LEFT ANTERIOR ASCENDING ARTERY. DIFFICULTY WAS EXPERIENCED WHEN ATTEMPTING TO DEFLATE THE BALLOONS. THE BALLOONS WERE REPORTED AS RIGID. REMOVAL OF THE BALLOONS FROM THE ANATOMY WAS DIFFICULT BUT SUCCESSFUL. OUTSIDE OF THE ANATOMY, IT WAS NOTED THAT THE BALLOONS WERE NOT COMPLETELY DEFLATED. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9121061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK STENT: 3.5 X 18 MM MULTI-LINK 8 (1012168-18)| 9121561)