BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 8884084 · Received August 12, 2019

    Report

    Report Number
    3007284313-2019-00248
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    August 7, 2019
    Report Date
    August 19, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UPDATED DEVICE INFORMATION (LOT, EXPIRATION DATE, UDI). H4: UPDATED DEVICE MANUFACTURE DATE. H6: UPDATED METHOD AND RESULT CODES. H6: CONCLUSION CODES REMAIN UNCHANGED. PER THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR 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 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 AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. 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.

    Additional Manufacturer Narrative · 1

    510K #: K172567. PER THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE, ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR RUPTURE.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM. AFTER ALL STENT GRAFTS WERE ADVANCED AND DEPLOYED, TOUCH-UP BALLOONING WAS PERFORMED USING A GORE® MOLDING & OCCLUSION BALLOON (MOB37/ LOT UNKNOWN). AFTER BALLOONING, PROCEDURAL ANGIOGRAPHY REPORTEDLY REVEALED A RIGHT COMMON ILIAC ARTERY RUPTURE. A DECREASE IN THE PATIENT¿S BLOOD PRESSURE WAS ALSO REPORTEDLY NOTED. THE PHYSICIAN REPORTEDLY ATTRIBUTED THE RUPTURE OF THE RIGHT COMMON ILIAC ARTERY TO THE TOUCH-UP BALLOONING. IT WAS ALSO REPORTED THAT THERE WAS A DISSECTION IN THE PATIENT¿S RIGHT COMMON ILIAC ARTERY PRIOR TO THE PROCEDURE. THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED WITH COILS, AND ADDITIONAL CONTRALATERAL LEG COMPONENT WAS PLACED IN THE RIGHT EXTERNAL ILIAC ARTERY TO TREAT THE RUPTURE. ACCORDING TO THE REPORT, NO BLOOD TRANSFUSION WAS REQUIRED. FINAL ANGIOGRAPHY REVEALED A TYPE II ENDOLEAK. THE PHYSICIAN ELECTED TO TAKE A WAIT-AND-WATCH APPROACH IN REGARD TO THE ENDOLEAK, AND THE PROCEDURE WAS CONCLUDED WITHOUT ANY FURTHER REPORTED COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678698 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 20553200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R