BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3130748 · Received May 24, 2013

    Report

    Report Number
    2024168-2013-03283
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    November 23, 2012
    Report Date
    May 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE VISION INSTRUCTIONS FOR USE IN THE ADVERSE EVENTS SECTION AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THE STENT WAS IMPLANTED IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A MAUDE REPORT, THAT ON (B)(6) 2012, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND SHORTNESS OF BREATH, HAVING BEEN SEEN PREVIOUSLY THAT WEEK IN THE EMERGENCY ROOM WITH THE SAME SYMPTOMS, PREVIOUSLY PLACED STENTS (UNSPECIFIED) IN THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA) WERE NOTED TO BE PATENT. HOWEVER, SEVERE DISEASE TO 95% WAS NOTED IN THE POSTERIOR DESCENDING ARTERY (PDA). PRE-DILATATION WAS PERFORMED WITH SEVERAL BALLOONS, AND A 3.0 X 28 VISION RX STENT WAS DEPLOYED WITH GOOD RESULTS. THE PATIENT WAS DISCHARGED WITH ANTI-COAGULANT MEDICATIONS, INCLUDING PLAVIX. ON (B)(6) 2012, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH ST SEGMENT MYOCARDIAL INFARCTION (STEMI). THE PATIENT HAD NOT BEEN TAKING PLAVIX. ANGIOGRAPHY REVEALED PATENT STENTS IN THE PROXIMAL AND MID RCA; HOWEVER THE RECENTLY PLACED VISION STENT IN THE PDA WAS NOTED TO BE 100% OCCLUDED WITH THROMBUS. THROMBECTOMY WAS PERFORMED WITH MULTIPLE PASSES ACHIEVING TIMI II FLOW AND INFLATIONS WITH 3.0 X 15 NC TREK BALLOON RESTORED TIMI III FLOW. THE PATIENT WAS TREATED WITH MEDICATIONS INCLUDING INTEGRILIN, ANGIOMAX, ASPIRIN AND PLAVIX. THE PATIENT WAS DISCHARGED WITH INSTRUCTIONS THAT HE MUST TAKE PLAVIX FOR AT LEAST 4 WEEKS, BEFORE REMAINING ON ASPIRIN AND COUMADIN ALONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231208 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2022041

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S