BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1021932 · Received March 28, 2008

    Report

    Report Number
    2024168-2008-00231
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Report Date
    February 27, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODE - A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE STENT DISLODGEMENT REPORTED. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT WAS RETURNED ON THE STYLET AND IN THE PROTECTIVE SHEATH. THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED. THERE WAS NO BLOOD OR CONTRAST VISIBLE ON THE STENT IMPLANT. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. A LASER MICROMETER WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETERS AND THEY DID NOT MEET MANUFACTURING CRITERIA. THE OUTER DIAMETERS WERE OVERSIZED. THE INNER DIAMETER OF THE ORANGE PROTECTIVE SHEATH WAS MEASURED AND MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED VISION STENT IMPLANT. STENT DISLODGEMENT MAY BE CAUSED BY, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/ OR ANATOMY, AND LESION MORPHOLOGY. THE SDS WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE STENT IMPLANT WAS RETURNED ON THE STYLET INSIDE THE PROTECTIVE SHEATH. THERE WAS NO DAMAGE NOTED TO THE STENT, ALTHOUGH THE STENT OUTER DIAMETER (OD) DIMENSION WAS OUTSIDE OF THE ACCEPTED MANUFACTURING SPECIFICATION. AT SOME POINT, POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM CAUSING THE BALLOON TO SLIGHTLY EXPAND, PARTIALLY DEPLOYING THE STENT. THIS WOULD CAUSE THE STENT IMPLANT TO BECOME LOOSE, FACILITATING STENT DISLODGEMENT DURING REMOVAL OF THE PROTECTIVE SHEATH. THE STENT OD IS VERIFIED 100% AT THE TIME OF MANUFACTURE AND UNITS IN THIS LOT WERE ALL WELL WITHIN THE REQUIRED SPECIFICATION. UNFORTUNATELY, BECAUSE THE SDS WAS NOT RETURNED, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED STENT DISLODGEMENT CANNOT BE DETERMINED. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORTS ISSUED FOR THIS PART/LOT NUMBER COMBINATION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT WHEN THE 3.5 X 18 MM RX VISION STENT DELIVERY SYSTEM (SDS) WAS OPENED, THERE WAS NO STENT IMPLANT PRESENT ON THE SDS BALLOON. THE STENT WAS FOUND DISLODGED FROM THE SDS AND INSIDE THE PROTECTIVE SHEATH. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT WITH THIS DEVICE. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 7110831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK