BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 3122722 · Received May 21, 2013

    Report

    Report Number
    2024168-2013-03203
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. 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. THE PRODUCT CODE LISTED AND THE PMA# LISTED IS BASED ON THE PREDICATE DEVICE (XIENCE V STENT SYSTEM) THAT IS DETERMINED TO BE SAME AND SIMILAR TO THE DELIVERY SYSTEM OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED INFLATION ISSUE COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. THE REPORTED PHYSICAL RESISTANCE 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CALCIFIED, MID RIGHT CORONARY ARTERY 3.0 X 18 IMPLANT PROCEDURE, AFTER PRE-DILATATED WITH A NON-ABBOTT 3.0 BALLOON TO 12 ATMOSPHERES (ATM), THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM, BUT IT WAS ABLE TO CROSS THE LESION BY SEATING THE GUIDE MORE SECURELY. THE BALLOON INDEFLATOR INDICATED ATMS OF 8, 10, AND 12 BUT THE BALLOON WOULD NOT INFLATE AT ALL TO DEPLOY THE IMPLANT. THE PATIENT EXPERIENCED SOME CHEST PAINS (ANGINA), BUT REPORTEDLY THIS WAS NOT A SERIOUS EVENT AND THE CHEST PAINS RESOLVED WITH THE DEVICE REMOVAL. THE DEVICE WAS REMOVED AS ONE UNIT WITHOUT DIFFICULTY AND THERE WAS CONFIRMATION THAT THE IMPLANT WAS STILL ON THE BALLOON. THE SAME WIRE WAS KEPT INSIDE THE PATIENTS ANATOMY. THE LESION WAS DILATED WITH A NC 3.0 BALLOON AND ANOTHER 3.0 X 18MM IMPLANT WAS DEPLOYED WITH THE SAME INDEFLATOR WITHOUT DIFFICULTY SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224702 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 30222P1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR