BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 19611020 · Received June 25, 2024

    Report

    Report Number
    2017233-2024-05054
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    August 19, 2022
    Report Date
    June 25, 2024
    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 ASD OCCLUDER INSTRUCTIONS FOR USE LIST ARRHYTHMIA REQUIRING TREATMENT AS A POTENTIAL DEVICE OR PROCEDURE RELATED ADVERSE EVENT. PIZZUTO, A., CUMAN, M., CANTINOTTI, M., FRANCHI, E., CORANA, G., VIACAVA, C., ASSANTA, N., AND SANTORO, G. (2022). RESCUE ATRIAL SEPTAL DEFECT CLOSURE WITH THE NEW GORE®¿CARDIOFORM ATRIAL SEPTAL DEFECT OCCLUDER. ANNALS OF PEDIATRIC CARDIOLOGY 15, 192-194. DOI: 10.4103/APC.APC_240_20 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.

    Description of Event or Problem · 0

    THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "RESCUE ATRIAL SEPTAL DEFECT CLOSURE WITH THE NEW GORE® CARDIOFORM ATRIAL SEPTAL DEFECT OCCLUDER" PUBLISHED ONLINE IN THE ANNALS OF PEDIATRIC CARDIOLOGY, 19 AUGUST 2022. THE ARTICLE REPORTS A 7-YEAR-OLD, 27 KG CHILD WAS ELECTIVELY ADMITTED FOR PERCUTANEOUS CLOSURE OF A LARGE ATRIAL SEPTAL DEFECT. ELECTROCARDIOGRAM (EKG) SHOWED SINUS RHYTHM WITH NORMAL ATRIOVENTRICULAR CONDUCTION AND INCOMPLETE RIGHT BUNDLE BRANCH BLOCK. TRANSTHORACIC ECHOCARDIOGRAM IMAGED A 14MM LARGE ASD, WITH ADEQUATE RIMS CAUSING MODERATE LEFT-TO-RIGHT SHUNT AND RIGHT CHAMBER VOLUME OVERLOAD. A 22MM ASO DEVICE WAS SUCCESSFULLY IMPLANTED. HOWEVER, 24 HOURS LATER, COMPLETE ATRIOVENTRICULAR BLOCK (AVB) WITH JUNCTIONAL ESCAPE RHYTHM WAS RECORDED. IMAGING SHOWED CORRECT POSITION OF THE DEVICE WITHOUT SIGNIFICANT RESIDUAL SHUNT, NEITHER IMPACT ON THE NEARBY STRUCTURES NOR PERICARDIAL EFFUSION. A SHORT TRIAL OF METHYLPREDNISOLONE WAS STARTED, RESULTING IN JUST A MILD IMPROVEMENT. TRANSCATHETER REMOVAL OF THE DEVICE WAS PLANNED. THE DEVICE WAS EASILY REMOVED USING A GOOSE-NECK CATHETER, WITH SUDDEN IMPROVEMENT OF INTRACARDIAC CONDUCTION THAT COMPLETELY NORMALIZED IN A FEW MONTHS. THEN, THE INTERVENTIONAL PROCEDURE WAS RESCHEDULED AFTER A FEW MONTHS. DYNAMIC SIZING CONFIRMED THE ASD DIAMETER (23¿24 MM). AFTER THE FINAL RELEASE OF A 44MM GORE® CARDIOFORM ASD OCCLUDER, TRANSIENT BRIEF PERIODS OF ADVANCED CONDUCTION DELAY WERE RECORDED AND QUICKLY REPLACED BY STABLE SINUS RHYTHM WITH 1ST-DEGREE AVB. THUS, SHE WAS DISCHARGED UNDER ORAL METHYLPREDNISOLONE FOR A FEW WEEKS, WITH THE DEVICE NICELY POSITIONED AND WITHOUT RESIDUAL SHUNT. AT THE 6-MONTH FOLLOW-UP EVALUATION, SHE REMAINED ASYMPTOMATIC WITHOUT CORTICOSTEROID THERAPY, IN SINUS RHYTHM, AND WITHOUT CONDUCTION ANOMALIES AT EKG MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640558 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Required Intervention