BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 17307169 · Received July 12, 2023

    Report

    Report Number
    2017233-2023-04106
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    February 4, 2021
    Report Date
    December 4, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: KRAMER, P., OPGEN-RHEIN, B.; BERGER, F.; NORDMEYER J., "LEFT ATRIAL DISC DEVICE THROMBOSIS AFTER ATRIAL DEFECT CLOSURE WITH THE GORE® CARDIOFORM SEPTAL OCCLUDER: A CASE SERIES¿, CATHETER CARDIOVASC INTERV., 2023;1¿5. DOI: 10.1002/CCD.30747. PUBLISHED DATE: 2023 JUN 14. D6A, IF IMPLANTED, GIVE DATE: THE ARTICLE DOES NOT PROVIDE THE DATE OF IMPLANT. THE BEST ESTIMATE OF AN IMPLANT DATE RANGE ACCORDING TO THE ARTICLE APPEARS TO BE 01-JAN-2016 TO 31-DEC-2022. H3, CODE "OTHER" - THE DEVICE REMAINS IN THE PATIENT. THEREFORE, AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED 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

    EMDR SECTION H6: CODES HAVE BEEN ADDED/UPDATED TO REFLECT THE EXTENT OF THE INVESTIGATION PERFORMED. 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. AN EVALUATION OF THE DEVICE WAS THEREFORE NOT PERFORMED. THIS COMPLAINT WAS INITIATED BASED ON INFORMATION RECEIVED FROM THE FIELD. NEITHER IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF, WHICH REMAINS IMPLANTED, WERE RETURNED FOR EVALUATION. THEREFORE THE CAUSE OF THE REPORTED OCCURRENCE OF THROMBUS AND THROMBOEMBOLISMS COULD NOT BE INDEPENDENTLY CONFIRMED DURING THE INVESTIGATION. THE AVAILABLE INFORMATION REPORTED DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION HAS OCCURRED. REPORTED THROMBOEMBOLIC EVENTS RESULTING IN CLINICAL SEQUELAE REPRESENT A KNOWN COMPLICATION OR ADVERSE EVENT THAT CAN OCCUR WHEN USING SEPTAL OCCLUDERS AND CAN ARISE AS A RESULT OF A MULTITUDE OF FACTORS, INCLUDING POST-OPERATIVE TREATMENT REGIMEN AND PATIENT-RELATED RISK FACTORS. NO ALLEGATION OF DEVICE MALFUNCTION WAS INDICATED WITH RESPECT TO DEVICE PERFORMANCE. BASED ON THE INCIDENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION, NO FURTHER INFORMATION WAS PROVIDED TO GORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE. 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.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: KRAMER, P., OPGEN-RHEIN, B.; BERGER, F.; NORDMEYER J., "LEFT ATRIAL DISC DEVICE THROMBOSIS AFTER ATRIAL DEFECT CLOSURE WITH THE GORE® CARDIOFORM SEPTAL OCCLUDER: A CASE SERIES¿, CATHETER CARDIOVASC INTERV., 2023;1¿5. DOI: 10.1002/CCD.30747. PUBLISHED DATE: 2023 JUN 14. THE ARTICLE REPORTS ON A SINGLE INSTITUTION EXPERIENCE OF LEFT ATRIAL DEVICE THROMBOSIS POST ATRIAL DEFECT CLOSURES. BETWEEN 2016 AND 2022, A TOTAL OF 521 PATIENTS WERE TREATED FOR PATENT FORAMEN OVALE (PFO) AND ATRIAL SEPTAL DEFECT (ASD) CONDITIONS. 74 PATIENTS WERE TREATED WITH THE GORE® CARDIOFORM SEPTAL OCCLUDER (GSO). THREE PATIENTS PRESENTED WITH A DEVICE THROMBOSIS BETWEEN 2 MONTHS AND 2.5 YEARS DURING THE FOLLOW-UP PERIOD. OUT OF THOSE THREE PATIENTS, PATIENT #3, A 55 YEAR OLD MALE PATIENT, UNDERWENT PFO CLOSURE WITH A 30 MM GSO DEVICE AFTER HAVING EXPERIENCED A POSTERIOR CEREBRAL ARTERY STROKE CONFIRMED BY COMPUTED TOMOGRAPHY (CT) IMAGING. ALMOST TWO YEARS POST INITIAL IMPLANT, THE PATIENT AGAIN PRESENTED WITH RECURRENT NEUROLOGICAL DEFICITS AND MAGNETIC RESONANCE IMAGING (MRI) REVEALED MULTIPLE SMALL CEREBRAL EMBOLISMS. SUBSEQUENT TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TOE) FOUND THROMBUS MASS MEASURING 4 × 15 MM ATTACHED TO THE LEFT ATRIAL DISC OF THE DEVICE. ANTICOAGULATION MEDICATION WITH PHENPROCOUMON WAS STARTED ADDITIONALLY TO THE ONGOING ANTIPLATELET ASPIRIN THERAPY. INITIALLY ONLY SLOWLY REGRESSING, THE THROMBUS WAS REPORTED TO HAVE COMPLETELY RESOLVED EVENTUALLY, WHICH WAS CONFIRMED BY TOE AFTER 14 MONTHS. THE PATIENT'S NEUROLOGICAL DEFICITS HAD ALSO REGRESSED ENTIRELY.

    Description of Event or Problem · 0

    OUT OF THOSE THREE PATIENTS, PATIENT #3, A 55 YEAR OLD MALE PATIENT, UNDERWENT PFO CLOSURE ON (B)(6) 2019 WITH A 30 MM GSO DEVICE AFTER HAVING EXPERIENCED A POSTERIOR CEREBRAL ARTERY STROKE CONFIRMED BY COMPUTED TOMOGRAPHY (CT) IMAGING. SUBSEQUENT TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TOE) PERFORMED ON (B)(6) 2021 FOUND THROMBUS MASS MEASURING 4 × 15 MM ATTACHED TO THE LEFT ATRIAL DISC OF THE DEVICE. IT WAS REPORTED TO GORE THAT THROMBUS FORMATION ON THE IMPLANTED GORE® CARDIOFORM SEPTAL OCCLUDER WAS CONSIDERED A HIGHLY LIKELY CAUSE FOR THE PATIENT EXPERIENCING RECURRENT NEUROLOGICAL DEFICITS / MULTIPLE SMALL CEREBRAL EMBOLISMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749059 GORE® CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention