BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 3153692 · Received June 8, 2013

    Report

    Report Number
    2024168-2013-03559
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SHAFT SEPARATION AND IMPLANT DAMAGE WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON THE VISUAL AND DIMENSIONAL ANALYSIS OF THE 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. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST IMPLANTATION, REMOVE THE ENTIRE SYSTEM AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE IMPLANT AND/OR DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4) - EXCESSIVE FORCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THOUGH THE DEVICE IS NOT APPROVED FOR SALE IN THE U.S., IT USES A DELIVERY SYSTEM WHICH IS SIMILAR TO A DEVICE SOLD IN THE U.S.

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO TREAT A CTO, MODERATELY CALCIFIED, NON-TORTUOUS, DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA). TWO NON-ABBOTT DILATATION CATHETERS (2.5X15 AND A 3.0X15) WERE USED TO PRE-DILATE THE LESION SITE. THE 3.5X18 MM DEVICE COULD NOT CROSS SEGMENT 1 IN ORDER TO REACH THE LESION IN SEGMENT 2. THE DEVICE WAS PUSHED HIGHLY TO CROSS SEGMENT 1 AND THE SHAFT SEPARATED OUTSIDE OF THE PATIENT'S BODY. THE DEVICE WAS REMOVED AND A XIENCE PRIME 3.5X18 MM WAS IMPLANTED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE WHEN THE 3.5X18MM IMPLANT WAS REMOVED, IT WAS NOTED TO BE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254403 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3031861

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR GUIDE WIRE: OCT PRESSURE WIRE