BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 2842935 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07385
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 27, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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. THE CUSTOMER REPORTED THE SCAFFOLD REMAINS IN THE PATIENT. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO DEVICE ISSUE OR PATIENT ISSUE, NO INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT HE WAS NOT HAPPY WITH THE PERFORMANCE OF ABSORB AND THERE WAS A DISSECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES THERE WAS NO DEVICE ISSUE AND NO DISSECTION.

    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 Other