BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB)

    MDR report key: 8578492 · Received May 3, 2019

    Report

    Report Number
    3007284313-2019-00130
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 5, 2019
    Report Date
    August 19, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DQY
    UDI-DI
    00733132639489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G5: CORRECTED/ADDITIONAL INFORMATION TO INCLUDE 510(K) NUMBER: K172567.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® MOLDING & OCCLUSION BALLOON CATHETER INSTRUCTIONS FOR USE (IFU), DO NOT INFLATE THE BALLOON IN AREAS OF SIGNIFICANT CALCIFIED PLAQUE. BALLOON RUPTURE AND / OR VESSEL DAMAGE MAY OCCUR. EXCESSIVE INFLATION VOLUME MAY RESULT IN BALLOON RUPTURE, EMBOLIZATION, VESSEL DAMAGE, VESSEL RUPTURE, OR PATIENT DEATH. ADDITIONALLY, PER IFU, ADVERSE EVENTS WHICH MAY REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO TRAUMA TO THE VESSEL WALL, INCLUDING SPASM, DISSECTION, PERFORATION OR RUPTURE.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION IS IN PROCESS. FURTHER INFORMATION WILL BE PROVIDED. PLEASE NOTE THAT THE MEDWATCH WITH MFR REPORT # 3013164176-2019-00048 WAS EMAILED TO FDA ON MAY 3, 2019 TO COVER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES AND A GORE® MOLDING & OCCLUSION BALLOON CATHETER FOR AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT'S RIGHT COMMON ILIAC ARTERY HAD CALCIFICATION. THE TRUNK-IPSILATERAL LEG AND CONTRALATERAL LEG WERE DEPLOYED. PLC181000J/18426893 WAS DEPLOYED TO EXTEND THE DISTAL OF CONTRALATERAL LEG (RIGHT LEG). AFTER TOUCH-UP BALLOONING, ANGIOGRAPHY SHOWED A DISTAL TYPE I ENDOLEAK OF PLC181000J/18426893. TOUCH-UP BALLOONING WAS PERFORMED AGAIN, BUT THE ENDOLEAK DID NOT RESOLVE. SINCE THE LANDING ZONE OF PLC181000J/18426893 IN RIGHT COMMON ILIAC ARTERY WAS SHORT AND FAR FROM THE INTERNAL ILIAC ARTERY, PLC181000J/18531757 WAS DEPLOYED DISTAL TO PLC181000J/18426893. TOUCH-UP BALLOONING AND ANGIOGRAPHY WERE PERFORMED AGAIN. THE ENDOLEAK STILL REMAINED AND AN EXTRAVASATION OF CONTRAST AGENT FROM THE DISTAL SIDE OF THE COMMON ILIAC ARTERY WAS OBSERVED. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED AND A PLC121200J/18491079 WAS DEPLOYED FROM PLC181000J/18531757 TO THE RIGHT EXTERNAL ILIAC ARTERY. TOUCH-UP BALLOONING WAS PERFORMED AGAIN AT THE DEVICE DISTAL END AND THE DEVICE OVERLAP AREA. ANGIOGRAPHY SHOWED THAT THE ENDOLEAK WAS RESOLVED AND THE EXTRAVASATION OF CONTRAST AGENT WAS NOT OBSERVED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN PERFORMED THE BALLOONING STRONGLY TO TREAT THE ENDOLEAK. REPORTEDLY, EXCESSIVE TOUCH-UP BALLOONING WAS LIKELY TO HAVE DAMAGED THE CALCIFIED ARTERY RESULTED TO VESSEL TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370240 AORTIC MOLDING AND OCCLUSION BALLOON CATHETER (MOB) CATHETER, PERCUTANEOUS DQY W.L. GORE & ASSOCIATES 18772173 00733132639489

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R