BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2973775 · Received December 19, 2007

    Report

    Report Number
    2024168-2007-00620
    Event Type
    Malfunction
    Date Received
    December 19, 2007
    Report Date
    November 27, 2007
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, PRODUCT PERFORMANCE GROUP ATTEMPTED TO OBTAIN COMPLETE EVENT INFORMATION, INCLUDING PATIENT INFORMATION AND PATIENT STATUS FROM THE HOSPITAL, FIELD CONTACT OR DISTRIBUTOR. RESULTS - A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE BALLOON. THE STENT IMPLANT WAS NOT ON THE BALLOON WHEN RETURNED. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON HAD LOOSE FOLDS. THERE WERE CRIMP MARKS ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. THERE WAS A KINK IN THE DISTAL SHAFT 2 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH AND STYLET WERE RETURNED. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT AND DID NOT MEET MANUFACTURING CRITERIA. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS MEASURED WITH A PIN GAUGE AND MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED DEVICE. ANALYSIS OF THE SDS NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE LOOSELY FOLDED BALLOON. THIS IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS PREPARED FOR USE. THE PRESENCE OF CONTRAST IN THE INFLATION LUMEN AND BALLOON SUGGESTS THAT, 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 TO BECOME LOOSE AND THE OUTER DIAMETERS TO BE OUT OF SPECIFICATION, AS NOTED DURING THE ANALYSIS. THE INNER DIAMETER OF THE PROTECTIVE SHEATH MET MANUFACTURING SPECIFICATION. CRIMP MARKS WERE VISIBLE ON THE 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. IN ADDITION, A KINK NOTED IN THE DISTAL SHAFT, WHICH WAS NOT REPORTED IN THE INCIDENT AND MAY HAVE OCCURRED DURING THE PACKAGING OF THE DEVICE FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR TO HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WAS NO NON-CONFORMING MATERIAL REPORTS ISSUED FOR THIS LOT THAT WERE RELATED TO THE REPORTED DISLODGEMENT STENT. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A PRODUCT QUALITY ISSUE. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT/NO MEDICAL INTERVENTION, HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE VISION STENT DISLODGEMENT FROM THE STENT DELIVERY SYSTEM (SDS) DURING PREPARATION OF THE DEVICE. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT. 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 7092031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK