BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1903713 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02467
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: 3.5X15(X2)VOYAGER; STENT: 2.5X15 MULTI LINK RX MINI VISION (PART 1007823-15, LOT 0071341). THE 2.5X15 MULTI LINK RX MINI VISION (PART 1007823-15, LOT 0071341 IS BEING FILED UNDER A SEPARATE MFR#. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH PREPARATION. THE STENT WAS DISLODGED AND NOT RETURNED, CONFIRMING THE REPORTED INFORMATION. CRIMP MARKS WERE VISIBLE ON THE BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE BALLOON WAS PARTIALLY INFLATED WITH AIR. THE SOFT TIP WAS SEPARATED AT THE DISTAL SEAL AND NOT RETURNED. THE FRACTURE FACE WAS JAGGED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THERE WAS A KINK IN THE BAYONET 3 MM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH AND THE GUIDE WIRE EXIT NOTCH WAS STRETCHED FOR A LENGTH OF 1MM. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE STRETCHED SHAFT, KINK, PARTIALLY INFLATED BALLOON, AND TIP SEPARATION MAY HAVE OCCURRED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE INNER DIAMETER OF THE TIP SEPARATION WAS MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. ALTHOUGH THE ANATOMICAL CONDITIONS WERE NOT REPORTED, FAILURE TO ADVANCE IS NOT OFTEN ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, IT WAS NOTED THAT ANOTHER VISION STENT WAS UNABLE TO CROSS THE LESION AND ALSO DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE SDS, RESISTANCE WAS FELT AND SOME FORCE, NOT EXCESSIVE, WAS APPLIED; HOWEVER THE STENT DISLODGED AND THE SDS WAS THEN REMOVED. IT SHOULD BE NOTED IN THE VISION INSTRUCTIONS FOR USE (IFU) IT STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING WITHDRAWAL OF THE CORONARY STENT SYSTEM, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. ADDITIONAL TREATMENT WAS USED TO CRUSH THE STENTS INTO THE PROXIMAL-MID RCA; PROLONGING THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA), AFTER PRE-DILATATION THE 2.75X18 RX VISION STENT SYSTEM WAS ADVANCED BUT COULD NOT CROSS TO THE LESION. WHILE REMOVING THE STENT SYSTEM, RESISTANCE WAS FELT AND SOME FORCE, NOT EXCESSIVE, WAS APPLIED. THE STENT DISLODGED IN THE PROXIMAL-MID RCA. A VOYAGER BALLOON WAS INFLATED TO CRUSH THE STENT IN THE PROXIMAL-MID RCA. A 2.5X15 MINI VISION STENT SYSTEM WAS ADVANCED INTO THE RCA AND THE STENT SYSTEM COULD NOT CROSS TO THE LESION. WHILE ATTEMPTING TO REMOVE THE STENT SYSTEM, RESISTANCE WAS FELT AND SOME FORCE, NOT EXCESSIVE, WAS APPLIED. THE STENT DISLODGED. ANOTHER VOYAGER BALLOON WAS USED TO CRUSH THE STENT IN THE PROXIMAL-MID RCA. DURING BOTH REMOVAL ATTEMPTS, ONCE RESISTANCE WAS FELT, THE STENT SYSTEMS WERE NOT REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT SEQUELA; HOWEVER PROCEDURE TIME WAS PROLONGED. APPROXIMATE TIME OF PROCEDURE WAS 4 HOURS. PATIENT IS REPORTED AS DOING FINE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-CLONMEL 0060341

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention