BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1876702 · Received October 15, 2010

    Report

    Report Number
    2024168-2010-02180
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED. THE 3.0 X 12MM VISIONS STENT (PART 1001842-12, LOT 9080441) IS BEING FILED UNDER A SEPARATE MFR #.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX VISION STENT DELIVERY SYSTEM (SDS) NOTED CONTRAST VISIBLE IN THE BALLOON AND INFLATION LUMEN, WHICH IS CONSISTENT WITH PREPARATION. THE STENT WAS DISLODGED FROM THE BALLOON AND RETURNED INSIDE THE ORANGE PROTECTIVE SHEATH, CONFIRMING THE REPORTED INFORMATION. THE ENTIRE LENGTH OF THE STENT WAS SMASHED. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE STENT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. IT IS POSSIBLE THAT DURING PREPARATION, POSITIVE PRESSURE WAS APPLIED TO THE SDS, SLIGHTLY EXPANDING THE STENT, SUCH THAT WHEN THE PROTECTIVE SHEATH WAS REMOVED, RESISTANCE WAS MET, FACILITATING THE STENT DISLODGEMENT. FURTHER HANDLING OF THE STENT DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS COULD HAVE CONTRIBUTED TO THE NOTED STENT DAMAGE. IT WAS REPORTED THE STENT DISLODGEMENT WAS NOT NOTED UNTIL THE SDS WAS ADVANCED INTO THE PATIENT ANATOMY. IT SHOULD BE NOTED THE VISION INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USING THE MULTI-LINK VISION RX OR MULTI-LINK VISION OTW CORONARY STENT SYSTEM, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. 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

    IT WAS REPORTED THAT THE PT PRESENTED WITH CARDIOGENIC SHOCK DUE TO MYOCARDIAL INFARCT AND DURING THE PROCEDURE WHILE INSERTING THE STENT DELIVERY SYSTEM (SDS) IN THE PT ANATOMY, UNDER FLUOROSCOPY, THE PHYSICIAN COULD NOT SEE THE STENT ON THE BALLOON/SDS. THE STENT IMPLANT WAS LOCATED STILL WITHIN THE PROTECTIVE SHEATH. REPORTEDLY A SECOND 3.0 X 12 MM VISION STENT WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN STATED THAT THE PT DIED SOON AFTER THE PROCEDURE FROM CARDIOGENIC SHOCK DUE TO MYOCARDIAL INFARCT WITH OCCLUSION OF THE CIRCUMFLEX ARTERY. THERE WAS NO ADDITIONAL INFO PROVIDED. THE DATE OF DEATH WAS NOT PROVIDED.

    Description of Event or Problem · 1

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 STENT:3.0X12 VISION(PART#1007842-12,(LOT#9080441)