BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1030452 · Received April 16, 2008

    Report

    Report Number
    2024168-2008-00296
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Report Date
    March 17, 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
    UY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: - PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE LOOSE STENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THE STENT IMPLANT WAS RETURNED ON THE STYLET WITH THE PROTECTIVE SHEATH. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE TIP SEAL LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE OUTER DIAMETER MEASUREMENTS MET MANUFACTURING CRITERIA. THE INNER DIAMETER OF THE PROTECTIVE SHEATH MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED SDS. IT WAS REPORTED THAT THE STENT IMPLANT WAS NOTED AS LOOSE WHEN REMOVING THE PROTECTIVE SHEATH. ANALYSIS OF THE DEVICE NOTED THAT THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON, NOT LOOSE AS REPORTED. NO OTHER DAMAGE WAS FOUND TO THE STENT OR SDS. THE TIP SEAL LENGTH, STENT OUTER DIAMETER DIMENSION, AND INNER DIAMETER DIMENSION OF THE PROTECTIVE SHEATH ALL MET MANUFACTURING CRITERIA. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. ALL ONLINE TESTING FOR THE LOT IN QUESTION MET STENT MOVEMENT CRITERIA, WHICH WOULD INDICATE THE UNIT HAD AN ADEQUATE CRIMP. THE RELEASE TESTING DATA WAS ALSO REVIEWED AND ALL SAMPLES FROM THIS LOT PASSED TESTING FOR STENT PLACEMENT, CRIMPED STENT OUTER DIAMETER, AND STENT MOVEMENT, ALSO INDICATING THE UNITS HAD AN ADEQUATE CRIMP. A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT COULD NOT BE DETERMINED, HOWEVER, THERE IS NO INDICATION OF A MANUFACTURING QUALITY ISSUE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: LOOSE//DISLODGED STENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: LOOSE/DISLODGED STENT. IT WAS REPORTED THAT WHILE REMOVING THE STENT FROM THE SHIELD, THE STENT WAS FOUND LOOSE, AND FOR THAT REASON IT WAS NOT IMPLANTED IN THE PATIENT. ADDITIONALLY, RETURNED GOODS ANALYSIS REVEALED THAT THE STENT WAS DISLODGED AND RETURNED ON THE STYLET.

    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 7012631

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK