BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2981498 · Received February 27, 2013

    Report

    Report Number
    2024168-2013-01158
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE 3.50 X 12 NC TREK DILATATION CATHETER MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED DISLODGEMENT WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE RX 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. ADDITIONALLY, IT WAS REPORTED THAT THE LESION SITE WAS NOT PRE-DILATED. THE IFU INSTRUCTS TO PRE-DILATE THE LESION WITH A PTCA CATHETER. (IN SAPHENOUS VEIN BYPASS GRAFT LESIONS, PREDILATATION MAY BE PERFORMED AT THE DISCRETION OF THE OPERATOR.) BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 3.5X15 RX VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED FOR DIRECT STENTING OF A HEAVILY CALCIFIED LESION IN THE MILDLY TORTUOUS OSTIAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE BALLOON WAS INFLATED TO DEPLOY THE STENT, HOWEVER, THE VESSEL APPEARED VIA ANGIOGRAM TO RECOIL. AS IT WAS BELIEVED THAT THE STENT HAD RECOILED, POST-DILATATION WAS PERFORMED USING A 3.5X12 NC TREK RX BALLOON DILATATION CATHETER (BDC), HOWEVER, AS THE VESSEL AND STENT STILL APPEARED TO RECOIL AFTER POST-DILATATION, THE PHYSICIAN THEN SUSPECTED THAT THE STENT WAS NOT ON THE BALLOON. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THAT THE STENT WAS NOT IN THE ANATOMY; THE DISLODGED STENT WAS FOUND INSIDE OF THE WASTE DISPOSAL CAN. UPON REVIEWING THE PROCEDURAL ANGIOGRAM, A VESSEL DISSECTION WAS NOTED. A 4.0X15 VISION SDS WAS THEN ADVANCED, TREATING THE LESION AND DISSECTION WITHOUT INCIDENT. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION AS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84809 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2030741

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention DILATATION CATHETER: 3.5X12 NC TREK RX