BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1112082 · Received August 6, 2008

    Report

    Report Number
    2024168-2008-00630
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITH BLOOD VISIBLE IN THE INFLATION LUMEN AND THE GUIDE WIRE LUMEN. THERE WAS NO CONTRAST VISIBLE. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A 1 CM IN LENGTH LONGITUDINAL RUPTURE ON THE BALLOON, STARTING AT THE DISTAL BALLOON SHOULDER. THERE WERE LONGITUDINAL SCRATCHES AT THE DISTAL END OF THE RUPTURE. THERE WERE MULTIPLE KINKS THROUGH OUT THE ENTIRE LENGTH OF THE SHAFT. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE RETURNED DEVICE ANALYSIS. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING WEAK MATERIALS, INTERACTIONS WITH OTHER DEVICES, INTERACTIONS WITH STENT STRUTS, PT ANATOMY, LESION CALCIFICATION, LESION TORTUOSITY, OR EXCESSIVE APPLIED PRESSURE. REPORTEDLY, THE TARGET LESION WAS NOT CALCIFIED. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THERE WAS A LONGITUDINAL RUPTURE IN THE BALLOON, WHICH WAS LOOSELY FOLDED. THE LOOSE FOLDS SUGGEST THAT THE DEVICE HAD BEEN INFLATED AS THE STENT WAS DEPLOYED. THERE WERE LONGITUDINAL SCRATCHES AT THE END OF THE RUPTURE, SUGGESTING THAT MECHANICAL DAMAGE CONTRIBUTED TO DAMAGING THE SURFACE OF THE BALLOON SUCH THAT UPON INFLATION, IT RUPTURED. ADDITIONALLY, IT WAS REPORTED THAT THE SDS WAS INFLATED ABOVE RATED BURST PRESSURE (RBP). THE DEVICE INSTRUCTIONS FOR USE (IFU) STATES: "DO NOT EXCEED RBP AS INDICATED PRODUCT LABEL. BALLOON PRESSURES SHOULD BE MONITORED DURING INFLATION. USE OF PRESSURES HIGHER THAN SPECIFIED ON PRODUCT LABEL MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION." IN THIS CASE, SINCE IT APPEARS THAT MECHANICAL DAMAGE TO THE SURFACE OF THE BALLOON CONTRIBUTED TO THE RUPTURE, THE ROOT CAUSE IS THE OPERATIONAL CONTEXT OF THE DEVICE. THERE WERE MULTIPLE KINKS OBSERVED ALONG THE LENGTH OF THE SDS, THOUGH THESE WERE NOT REPORTED IN THE INCIDENT INFO. IT IS POSSIBLE THAT THE KINKS OCCURRED DURING OR AFTER THE PROCEDURE, AS THE SDS WAS PACKAGED AND SHIPPED TO ABBOTT VASCULAR FOR ANALYSIS. IT DOES NOT APPEAR THAT THE KINKS ARE RELATED TO THE REPORTED BALLOON RUPTURE. A REVIEW OF THE DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS WHICH COULD HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. THERE ARE NO INDICATIONS OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR BALLOON DAMAGE AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY BALLOON RBP INTEGRITY. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    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 THE PROCEDURE WAS TO TREAT A NON-CALCIFIED LESION IN THE RCA. AFTER PRE-DILATATION, THE VISION STENT WAS PLACED. THE BALLOON RUPTURED AT 18 ATM (ABOVE RBP) WHILE DEPLOYING THE STENT. THE STENT WAS SUFFICIENTLY EXPANDED AND THERE WAS NO DIFFICULTY REMOVING THE STENT DELIVERY SYSTEM (SDS). THERE WERE NO PT EFFECTS REPORTED. 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 8011431

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR