BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCAFFOLD, DISSECTION REPAIR

    MDR report key: 20820081 · Received December 2, 2024

    Report

    Report Number
    3012608866-2024-00194
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    January 1, 2021
    Report Date
    December 2, 2024
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN ACTION ITEM IDENTIFIED IN AN INTERNAL CAPA, A REFRESHER TRAINING FOR THE PHILIPS SALES REPRESENTATIVES WAS REQUIRED TO REVIEW THE COMPLAINT REPORTING REQUIREMENTS. FROM THAT TRAINING, POST MARKET SURVEILLANCE (PMS) WAS MADE AWARE OF RETROSPECTIVE COMPLAINTS THAT HAD NOT BEEN REPORTED, RESULTING IN THIS RETROSPECTIVE MDR. BLOCK A: THE PATIENT'S DOB OR AGE AT TIME OF EVENT, SEX, GENDER, WEIGHT, ETHNICITY, AND RACE ARE UNKNOWN. THE DATE OF EVENT WAS NOT PROVIDED, THUS (B)(6) 2021 WAS LISTED. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. BLOCK D1: THE BRAND NAME IS UNKNOWN; HOWEVER, THE AFFECTED DEVICES ARE FOR THE TACK ENDOVASCULAR SYSTEM. BLOCK D4/G4/H4: THE LOT NUMBER WAS NOT PROVIDED; THUS, THE FOLLOWING INFORMATION ARE UNKNOWN: BRAND NAME, MODEL NUMBER, CATALOG NUMBER, UNIQUE ID, EXPIRATION DATE, MANUFACTURE DATE, AND PMA NUMBER. BLOCK E: THE FACILITY DETAILS WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION ARE UNKNOWN: REPORTER NAME AND CONTACT INFO, FACILITY NAME AND ADDRESS. THE TACK DEVICE WAS NOT RETURNED; THUS, NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE. AFTER DEPLOYMENT, THE TACK WAS DISPLACED AS IT MOVED FROM ITS ORIGINAL DEPLOYED LOCATION. A SNARE WAS USED TO ATTEMPT REMOVAL, BUT WAS UNSUCCESSFUL. THEREFORE, A STENT WAS PLACED TO JAIL THE TACK TO THE VESSEL WALL. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE OF A TACK DISPLACEMENT, REQUIRING INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303894 SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK MFG AND SIZE: GUIDE CATHETER| UNK MFG AND SIZE: GUIDE WIRE| UNK MFG AND SIZE: INTRODUCER SHEATH