BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 4221379 · Received November 3, 2014

    Report

    Report Number
    2024168-2014-07175
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED INFLATION ISSUE AND LEAK WERE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION 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. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATED THERE HAD BEEN NO SIMILAR INFLATION ISSUE OR LEAK INCIDENTS REPORTED FOR THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. 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# ARE BASED ON THE PREDICATE DEVICE (XIENCE V STENT SYSTEM) THAT IS DETERMINED TO BE SAME AND SIMILAR TO THE DELIVERY SYSTEM OF THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY. PRE-DILATATION WAS PERFORMED WITH A NC TREK 2.5X20 MM BALLOON AT 8 ATMOSPHERES (ATM) WITH RESIDUAL STENOSIS LESS THAN 40% AFTER PRE-DILATATION. AN 2.5X18MM IMPLANT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, THE BALLOON COMPLETELY FAILED TO INFLATE. A LEAK WAS CONFIRMED VISUALLY OUTSIDE OF THE PATIENT. NO RESISTANCE WAS FELT DURING REMOVAL OF THE SHEATHS DURING PREP OR DURING ADVANCEMENT OF THE DELIVERY SYSTEM. THE DEVICE WAS REPLACED WITH A 2.5X23MM IMPLANT DELIVERY SYSTEM, WHICH INFLATED PROPERLY. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701155 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4040961

    Patients

    Seq Age Sex Outcome Treatment
    1