BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 2862921 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07747
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 13, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: HT BALANCE MIDDLEWEIGHT. GUIDE CATH: EBU 4. OTHER: GUIDELINER 6F. THE SCAFFOLD REMAINS IN THE PATIENT AND DELIVERY SYSTEM IS NOT RETURNING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THOUGH THE DEVICE ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM 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, 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). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION BELOW THE CIRCUMFLEX (CX) BIFURCATION. DURING DEPLOYMENT OF THE ABSORB SCAFFOLD, EXCESSIVE DOG BONING OF THE ABSORB BALLOON OCCURRED. DUE TO THE DOG BONING THE BALLOON PROTRUDED FROM THE CX AND OCCLUDED THE LEFT ANTERIOR DESCENDING ARTERY. THE FINAL BALLOON PRESSURE WAS MAINTAINED FOR 30 SECONDS, AT WHICH TIME THE PATIENT EXPERIENCED SOME ANGINA. THESE ISSUES RESOLVED UPON DEFLATION OF THE BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1