BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 15490084 · Received September 27, 2022

    Report

    Report Number
    2017233-2022-03352
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    August 24, 2022
    Report Date
    April 8, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GORE® CARDIOFORM SEPTAL OCCLUDER INVOLVED IN THIS CASE REMAINS IMPLANTED. 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: COMPONENT CODE: ADDED CODES G04088, G04027. H6: TYPE OF INVESTIGATION: ADDED CODES B11, B13, B20. H6: INVESTIGATION CONCLUSIONS: ADDED CODE D12. H6: INVESTIGATION FINDINGS, CODE C19: THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. WITH THE INFORMATION REPORTED TO GORE THIS INVESTIGATION IS CONSIDERED COMPLETE, THE CAUSE OF THE COMPLAINT WAS UNABLE TO BE DETERMINED. ACCORDING TO THE GORE® CARDIOFORM SEPTAL OCCLUDER INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE OCCLUDER MAY INCLUDE, BUT ARE NOT LIMITED TO: THROMBOSIS OR THROMBOEMBOLIC EVENT RESULTING IN CLINICAL SEQUELAE. H6: HEALTH EFFECT - IMPACT CODE: REPLACED CODE F2303 WITH CODE F12. H6: INVESTIGATION FINDINGS: REPLACED CODE C21 WITH CODE C19. H6: INVESTIGATION CONCLUSIONS: REPLACED CODE D16 WITH CODE D15.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT ON (B)(6) 2022, A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT A PATENT FORAMEN OVALE (PFO). AT ROUTINE 6 MONTHS FOLLOW-UP, TRANS-CRANIAL DOPPLER ULTRA-SCAN WAS UNREMARKABLE. REPORTEDLY HOWEVER, THE PATIENT STOPPED ALL ANTIPLATELET MEDICATION IRRESPECTIVE OF HER THROMBOPHILIC CONDITION AND COMMENCED OESTROPROGESTINIC REPLACEMENT THERAPY. ADDITIONALLY, ASPIRIN THERAPY WAS STARTED AS A LIFE-LONG TREATMENT. ON (B)(6) 2022, THE PATIENT REPORTEDLY EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA) AND THROMBUS FORMATION ON THE LEFT DISC OF THE DEVICE SHOWED. IT WAS ALSO REPORTED THAT GOING FORWARD, THE PATIENT'S HEALTH CONDITION IS GOING TO BE CLOSELY MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078317 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention