BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3170344 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03726
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT DETACHMENT AND STENT DAMAGE WERE CONFIRMED. THE REPORTED FAILURE TO CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING ANGIOPLASTY FOR THE 90% HEAVILY CALCIFIED STENOSIS OF THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) . THE LESION WAS PREDILATED WITH AN UNSPECIFIED 1.5 X 8 MM BALLOON AT 12 ATMOSPHERES (ATM). BUT THE LESION WAS VERY TIGHT WITH A CALCIUM SPUR, THEREFORE THE LESION WAS NOT OPENED WELL. THEN A 2.0 X 8 MM MINI TREK BALLOON WAS INFLATED AT 12 ATM TO OPEN THE LESION FURTHER. ONCE TIMI I FLOW WAS ESTABLISHED, THE RX VISION 3.0 X 15 MM STENT WAS ADVANCED TO THE LESION LOCATION. THE STENT DID NOT CROSS TO THE LESION. DURING THE CROSSING ATTEMPT, THE PROXIMAL SHAFT BECAME SEPARATED AND AFTER RETRACTION OF THE DEVICE, DISTAL STENT STRUTS WERE NOTED TO BE FLARED. A 3.0 X 15 MM MULTI-LINK 8 STENT WAS IMPLANTED TO TREAT THE LESION WITH GOOD RESULTS, TIMI III FLOW AND NO RESIDUAL STENOSIS, AND NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270400 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2041741

    Patients

    Seq Age Sex Outcome Treatment
    1