BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1760618 · Received July 14, 2010

    Report

    Report Number
    2024168-2010-01394
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 21, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVAL SUMMARY: EVAL OF THE RETURNED STENT DELIVERY SYSTEM (SDS) FOUND BLOOD ON THE DISTAL SHAFT, ON THE HYPOTUBE, AND ON THE BALLOON. THERE WAS NO CONTRAST VISIBLE. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS NOT RETURNED. THERE WERE CRIMP MARKS ON THE BALLOON WHERE THE STENT HAD BEEN BETWEEN THE MARKERS. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS A TEAR IN THE DISTAL END OF THE TIP. THERE WERE TWO BENDS IN THE HYPOTUBE 12CM AND 14.5CM DISTAL TO THE STRAIN RELIEF TUBING. SINCE THE TEAR AND TWO BENDS WERE NOT REPORTED IN THE INCIDENT INFO, THE TEAR AND BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING THE PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE INNER MEMBER. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE HIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, IT IS LIKELY THAT INTERACTION WITH THE HEAVILY TORTUOUS AND CALCIFIED LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, RE-INSERTION OF THE VISION SDS AND/OR INTERACTION WITH CALCIFIED LESION LIKELY CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT, WHICH RESULTED IN ANOTHER VISION STENT IMPLANT EMBEDDING THE DISLODGED STENT IN AN UNINTENDED SITE. IT SHOULD BE NOTED IN THE VISION INSTRUCTIONS FOR USE IT STATES: AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. IN THIS CASE, THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PROFILE DIMENSION 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 DAMAGE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT DISLODGEMENT. TIME OF DEVICE ISSUE: DURING PROCEDURE. ADVERSE EVENT (AE): STENT EMBEDDED IN UNINTENDED SITE. TIME OF AE: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE IN THE SUPERIOR TAKEOFF OF THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA), AFTER PRE-DILATATION, THE VISION STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE TARGET LESION. THE SDS WAS REMOVED AND BALLOON DILATATION WAS PERFORMED AGAIN. THE VISION SDS WAS ADVANCED A SECOND TIME, BUT STILL COULD NOT CROSS THE LESION, DESPITE USE OF AN UNSPECIFIED BUDDY WIRE. DURING SDS REMOVAL THROUGH THE GUIDE CATHETER, IT WAS NOTICED THAT THE STENT HAS DISLODGED FROM THE BALLOON AND WAS FLOATING IN THE PROXIMAL RCA. ANOTHER VISION STENT WAS IMPLANTED, EMBEDDING THE FLOATING STENT IN AN UNINTENDED SITE IN THE PROXIMAL RCA. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR CLONMEL NA 8021931

    Patients

    Seq Age Sex Outcome Treatment
    1 DIL CATH: 3.0X15 VOYAGER