BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® TRI-LOBE BALLOON CATHETER

    MDR report key: 16816605 · Received April 26, 2023

    Report

    Report Number
    2017233-2023-03888
    Event Type
    Injury
    Date Received
    April 26, 2023
    Date of Event
    March 29, 2023
    Report Date
    April 26, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    DQY
    PMA / PMN Number
    K180919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT MEDICATIONS: LIPITOR, CARDIZEM, ULTRAM, PLAQUENIL, LASIX, ADVAIR, NEURONTIN, SYNTHROID, ZOLOFT, ATIVAN, AND TYLENOL. ACCORDING TO THE GORE® TRI-LOBE BALLOON CATHETER INSTRUCTIONS FOR USE, ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO TRAUMA TO THE VESSEL WALL INCLUDING RUPTURE. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC ANEURYSM. IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN WAS BALLOONING THE DISTAL END OF THE IMPLANTED GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WITH A GORE® TRI-LOBE BALLOON CATHETER (LOT/SERIAL NUMBER IS UNKNOWN). REPORTEDLY THE PHYSICIAN WAS ¿AGGRESSIVELY¿ BALLOONING AND RUPTURED THE AORTA, DISTAL TO THE IMPLANTED DEVICE. A BLOOD TRANSFUSION WAS REQUIRED. THE PHYSICIAN IMPLANTED AN ADDITIONAL GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT THE RUPTURED AORTA. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685430 GORE® TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS DQY W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization