BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 15483684 · Received September 26, 2022

    Report

    Report Number
    2017233-2022-03348
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    September 6, 2022
    Report Date
    February 8, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE ¿STENT MIGRATION: DANGEROUS FLIGHT BUT SAFE LANDING¿ PUBLISHED BY FEDERICO FONTANA ET. AL IN THE JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, VOLUME 32, ISSUE 10, OCTOBER 2021, PAGE 1515. NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. PATIENT AGE WAS 59 YEARS AND GENDER FEMALE AS MENTIONED IN THE ARTICLE. THE DATE OF INCIDENT IS UNKNOWN. THEREFORE DATE OF INCIDENT WAS DETERMINED AS DATE WHEN LITERATURE ARTICLE WAS ACCEPTED, HERE JULY 17, 2021. NAME: CBAS® HEPARIN SURFACE, MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC., LOT NUMBER: UNK. FOR FURTHER EVALUATION THE AUTHOR WAS ASKED, IF MORE DETAILS SUCH AS SERIAL-NO., IMPLANT DATE, DATE OF EVENT, PATIENT ID AND WEIGHT AND POSSIBLE ROOT CAUSE ARE AVAILABLE. CBAS® HEPARIN SURFACE, INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. 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

    H6, C19: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. H6/C21: ENGINEERING EVALUATION SUMMARY: THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CMDS) DEVICE EVALUATION SHOWED THE FOLLOWING: THE FINDINGS OF THE EVALUATION ARE CONSISTENT WITH THE REPORTED EVENT DESCRIPTION THAT THE CURVED LEADING OLIVE WAS SEPARATED FROM THE CATHETER. BASED ON THE INVESTIGATION THE OLIVE WAS LIKELY NOT SUFFICIENTLY BONDED TO THE CATHETER. PER ENGINEERING EVALUATION TASK PROCEDURE, THE SEPARATION OF THE CURVED LEADING OLIVE FROM THE CATHETER IS LIKELY A MANUFACTURING DEFICIENCY RELATED TO THE CMDS OLIVE BONDING PROCESS. BASED ON THIS INVESTIGATION, THE LIKELY ROOT CAUSE IS THE CATHETER END WAS DAMAGED POST-TRIMMING OR PRE-OLIVE ENTRY DURING THE OLIVE BONDING PROCESS. THE RISK MANAGEMENT FILE WAS REVIEWED, AND THE ASSOCIATED WORST-CASE SEVERITY OF HARM IS CRITICAL. THEREFORE, A CAPA IS REQUIRED FOR THIS EVENT. CAPA WAS OPENED TO ADDRESS THIS EVENT. IMAGING EVALUATION SUMMARY: THE IMAGES RECEIVED CANNOT BE USED TO PERFORM A FULL IMAGING EVALUATION BECAUSE THEY DO NOT MEET THE DICOM STANDARD. THE EXTENT AND ACCURACY OF THE OBSERVATIONS AND FINDINGS MAY BE LIMITED DUE TO THE COMPLETENESS, FORMAT AND/OR QUALITY OF THE IMAGES PROVIDED FOR REVIEW. GORE CANNOT GUARANTEE THE IMAGES PROVIDED ARE COMPLETE, ACCURATE OR LACK ALTERATION. THEREFORE, GORE CANNOT GUARANTEE ALL KEY FINDINGS HAVE BEEN CAPTURED OR THAT THE FINDINGS ARE ACCURATE. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ONE MEDICAL RADIOGRAPH JPG SUBMITTED FOR EVALUATION. UNABLE TO CONFIRM: LEADING END OF CATHETER BROKEN, LEADING OLIVE SEPARATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR THORACIC AORTIC ANEURYSM USING A 34MM X 34MM X 10CM GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE DEVICE WAS ADVANCED VIA DSF2233 SHEATH THROUGH COOK LANDQUEST WIRE. AFTER THE STENT WAS SUCCESSFULLY EXPANDED, IT WAS FOUND THE LEADING OLIVE WAS DETACHED AND LEFT IN AORTA. THEN THE PHYSICIAN USED A SNARE TO RETRIEVE THE LEADING OLIVE OUT OF PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302592 GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male