BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    MDR report key: 17574539 · Received August 18, 2023

    Report

    Report Number
    2017233-2023-04210
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 27, 2023
    Report Date
    November 7, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132654420
    PMA / PMN Number
    P210032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H.6. MEDICAL DEVICE PROBLEM CODE A210106 REMOVED, AS THE SERIAL NUMBER MISMATCH WAS DETERMINED TO BE REPORTED IN ERROR. H.6. TYPE OF INVESTIGATION CODE B21 UPDATED TO CODE B14 WITH COMPLETION OF PHR REVIEW. H.6. TYPE OF INVESTIGATION - CODE UPDATED TO CODE B01 AS A RESULT OF THE COMPLETION OF DEVICE EVALUATION. H.6. INVESTIGATION CONCLUSIONS: CODE D16 UPDATED TO CODE D15. THE TBE SIDE BRANCH (SB) CATHETER SEPARATED AT THE JUNCTION BETWEEN THE TRAILING END OF THE TRANSITION AND THE LEADING END OF THE DUAL LUMEN. THE FINDINGS OF THE EVALUATION ARE CONSISTENT WITH THE EVENT DESCRIPTION, WHICH REPORTS ¿THE LEADING END OF THE DELIVERY SYSTEM BROKE OFF¿ UPON CATHETER RETRACTION WHILE TAKING THE CURVE OF THE FIRST SIDE BRANCH. PER THE MANUFACTURING PRODUCT HISTORY REVIEW (PHR), (B)(4), A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE MANUFACTURING LOT MET ALL PRE-RELEASE SPECIFICATIONS. NO ROOT CAUSE CAN BE CONFIRMED FOR THE REPORTED EVENT OF CATHETER SEPARATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE PATIENT WAS TREATED FOR A PSEUDOANEURYSM. THE PHYSICIAN INSERTED A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. DURING PLACEMENT, THE SIDE BRANCH PORTAL ENDED UP ON INNER CURVE OF THE AORTA, RATHER THAN THE PREFERRED LOCATION ON THE OUTER CURVE. THE SHEATH FROM THE INNOMINATE WAS PAST THE OSTIUM BUT ABOVE THE GRAFT. THE SECOND SIDE BRANCH DEPLOYED AND THE OLIVE TIP BROKE OFF, TAKING THE CURVE OF THE FIRST SIDE BRANCH. IT WAS REMOVED WITH NO HARM TO THE PATIENT. IT WAS NOTED THAT A SOFT GLIDE WIRE WAS USED INSTEAD OF A STIFF WIRE, AS THE SCRUB TECH HANDED UP THE WRONG WIRE. THE SURGICAL TEAM DIDN'T WANT TO DO A WIRE EXCHANGE, SO DECIDED TO TRY AND MAKE IT STIFF BY PULLING ON BOTH ENDS. THE PHYSICIAN IS UNSURE IF USING THE SOFT GLIDE WIRE CONTRIBUTED TO THE EVENT, BUT THAT HE WOULD USE A STIFF WIRE IN THE FUTURE. IT WAS ALSO NOTED THAT THE SERIAL NUMBER ON THE BOX AND PACKAGE DID NOT MATCH THE SERIAL NUMBER ON THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331429 GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132654420

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention