BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® CARDIOFORM ASD OCCLUDER

    MDR report key: 18127617 · Received November 13, 2023

    Report

    Report Number
    2017233-2023-04401
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    October 18, 2023
    Report Date
    May 13, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. H3: CODE "OTHER" WAS SELECTED AS THE MEDICAL DEVICE WAS DISCARDED AT FACILITY. RETURN NOT POSSIBLE. 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: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM WAS UPDATED PER ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THIS PATIENT UNDERWENT A TREATMENT TO CLOSE A 19 MM STOP-FLOW BALLOON SIZED ATRIAL SEPTAL DEFECT USING 44 MM GORE® CARDIOFORM ASD OCCLUDER. REPORTEDLY, THE PATIENT¿S LEFT ATRIAL ROOF WAS SMALL IN SPACE. AT FIRST ATTEMPT TO DEPLOY THE OCCLUDER, THE LEFT ATRIAL DISC PROLAPSED. AT THE SECOND ATTEMPT, A RESIDUAL SHUNT WAS OBSERVED. THE PHYSICIAN CONSIDERED THAT LEFT ATRIAL SPACE IS SMALL FOR THE SELECTED SIZE OF THE OCCLUDER, AND ADJUSTING ANGLE OF THE OCCLUDER TO FIT TO THE SEPTUM IS BEING DIFFICULT. THEREFORE, HE REMOVED THE OCCLUDER ONCE AND DECIDED TO RESHAPE THE PROXIMAL TIP OF THE DEVICE. WHILE PHYSICIAN WAS MANUALLY RESHAPING THE PROXIMAL TIP OF THE DEVICE, A SNAPPING SOUND WAS HEARD. THE PHYSICIAN THEN PUT THE DEVICE IN WATER AND MADE SURE IT CAN BE PROPERLY DEPLOYED AND RESTORED. SINCE NO ISSUES WERE OBSERVED IN THE WATER, THE DEVICE WAS INSERTED AGAIN TO THE PATIENT. UPON DEPLOYING THE LEFT ATRIAL DISC, THE ANGLE OF THE OCCLUDER DIVERGED FROM THE CATHETER. IT WAS CONFIRMED UNDER FLUOROSCOPIC IMAGE THAT THE MANDREL WAS BROKEN OFF AT ABOUT 2.5 CM DISTAL TO THE LEFT ATRIAL EYELET. THE BROKEN PROXIMAL PORTION OF THE MANDREL WITH THE OCCLUDER WAS STILL CONNECTED TO THE DELIVERY SYSTEM WITH THE LOCKING LOOP. THE PHYSICIAN INSERTED AN 8-FR SHEATH FROM INTERNAL JUGULAR VEIN AND ATTEMPTED TO LIFT THE LEFT ATRIAL EYELET UPWARD USING A 6-FR SNARE TO ALIGN ITS ANGLE WITH THE CATHETER. THE ATTEMPT WAS UNSUCCESSFUL, THEREFORE, THE 6-FR SHEATH WAS REPLACED TO A 12-FR SHEATH AND TWO SNARES (6-FR AND 4-FR) WERE USED TO CAPTURE THE LEFT ATRIAL EYELET. THE OCCLUDER WAS SUCCESSFULLY RECAPTURED AND THE DEVICE WAS RETRACTED INTO A LONG SHEATH. THE DEVICE WAS REMOVED THROUGH INFERIOR VENA CAVA. THE FEMORAL VEIN WAS CUT DOWN FROM WHICH THE DEVICE WAS SUCCESSFULLY TAKEN OUT OF THE PATIENT. NON-GORE DEVICE (FIGULLA® FLEX II, JAPAN LIFELINE CO., LTD) WAS USED AS A REPLACEMENT AND THE ATRIAL SEPTAL DEFECT WAS SUCCESSFULLY CLOSED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT HE MIGHT HAVE APPLIED TO MUCH PRESSURE AT ONE POINT WHILE RESHAPING THE PROXIMAL TIP OF THE DEVICE, CAUSING THE DAMAGE TO THE MANDREL. IT WAS REPORTED THAT DEVICE MIGHT HAVE BEEN INITIALLY DAMAGED OUTSIDE OF THE PATIENT FOR WHICH THE MANDREL BECOME COMPLETELY BROKEN OFF WHILE BEING ADVANCED INSIDE THE PATIENT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THIS PATIENT UNDERWENT A TREATMENT TO CLOSE A 19 MM STOP-FLOW BALLOON SIZED ATRIAL SEPTAL DEFECT USING 44 MM GORE® CARDIOFORM ASD OCCLUDER. REPORTEDLY, THE PATIENT¿S LEFT ATRIAL ROOF WAS SMALL IN SPACE. AT FIRST ATTEMPT TO DEPLOY THE OCCLUDER, THE LEFT ATRIAL DISC PROLAPSED. AT THE SECOND ATTEMPT, A RESIDUAL SHUNT WAS OBSERVED. THE PHYSICIAN CONSIDERED THAT LEFT ATRIAL SPACE IS SMALL FOR THE SELECTED SIZE OF THE OCCLUDER, AND ADJUSTING ANGLE OF THE OCCLUDER TO FIT TO THE SEPTUM IS BEING DIFFICULT. THEREFORE, HE REMOVED THE OCCLUDER ONCE AND DECIDED TO RESHAPE THE PROXIMAL TIP OF THE DEVICE. WHILE PHYSICIAN WAS MANUALLY RESHAPING THE PROXIMAL TIP OF THE DEVICE, A SNAPPING SOUND WAS HEARD. THE PHYSICIAN THEN PUT THE DEVICE IN WATER AND MADE SURE IT CAN BE PROPERLY DEPLOYED AND RESTORED. SINCE NO ISSUES WERE OBSERVED IN THE WATER, THE DEVICE WAS INSERTED AGAIN TO THE PATIENT. UPON DEPLOYING THE LEFT ATRIAL DISC, THE ANGLE OF THE OCCLUDER DIVERGED FROM THE CATHETER. IT WAS CONFIRMED UNDER FLUOROSCOPIC IMAGE THAT THE MANDREL WAS BROKEN OFF AT ABOUT 2.5 CM DISTAL TO THE LEFT ATRIAL EYELET. THE BROKEN PROXIMAL PORTION OF THE MANDREL WITH THE OCCLUDER WAS STILL CONNECTED TO THE DELIVERY SYSTEM WITH THE LOCKING LOOP. THE PHYSICIAN INSERTED AN 8-FR SHEATH FROM INTERNAL JUGULAR VEIN AND ATTEMPTED TO LIFT THE LEFT ATRIAL EYELET UPWARD USING A 6-FR SNARE TO ALIGN ITS ANGLE WITH THE CATHETER. THE ATTEMPT WAS UNSUCCESSFUL, THEREFORE, THE 6-FR SHEATH WAS REPLACED TO A 12-FR SHEATH AND TWO SNARES (6-FR AND 4-FR) WERE USED TO CAPTURE THE LEFT ATRIAL EYELET. THE OCCLUDER WAS SUCCESSFULLY RECAPTURED AND THE DEVICE WAS RETRACTED INTO A LONG SHEATH. THE DEVICE WAS REMOVED THROUGH INFERIOR VENA CAVA. THE FEMORAL VEIN WAS CUT DOWN FROM WHICH THE DEVICE WAS SUCCESSFULLY TAKEN OUT OF THE PATIENT. NON-GORE DEVICE (FIGULLA® FLEX II, JAPAN LIFELINE CO., LTD) WAS USED AS A REPLACEMENT AND THE ATRIAL SEPTAL DEFECT WAS SUCCESSFULLY CLOSED. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT HE MIGHT HAVE APPLIED TO MUCH PRESSURE AT ONE POINT WHILE RESHAPING THE PROXIMAL TIP OF THE DEVICE, CAUSING THE DAMAGE TO THE MANDREL. IT WAS REPORTED THAT DEVICE MIGHT HAVE BEEN INITIALLY DAMAGED OUTSIDE OF THE PATIENT FOR WHICH THE MANDREL BECOME COMPLETELY BROKEN OFF WHILE BEING ADVANCED INSIDE THE PATIENT. ADDITIONAL INFORMATION: THE FOLLOWING LITERATURE WAS REVIEWED BY GORE: TITLE: COMPLETE FRACTURE AND RETRIEVAL OF THE DELIVERY SYSTEM OF GORE CARDIOFORM ATRIAL SEPTAL DEFECT OCCLUDER DURING TRANSCATHETER CLOSURE. SOURCE: CARDIOVASCULAR REVASCULARIZATION MEDICINE (2024). A 60YEAR-OLD MALE WAS ADMITTED FOR THE TRANSCATHETER CLOSURE OF AN ATRIAL SEPTAL DEFECT. TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED A DEFECT MEASURING 19.0 × 14.4 MM, WIDE RANGE OF AORTIC RIM DEFICIENCY, AND SEPTAL MALALIGNMENT. A 44 MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED. FIRST, WE ATTEMPTED DEVICE DEPLOYMENT USING THE STANDARD TECHNIQUE WITH A 14 FR PRE-SHAPED SHEATH, BUT THIS WAS UNSUCCESSFUL. WE OPTED TO USE THE WIRE SUPPORT AND BENDING TECHNIQUES TO ACHIEVE BETTER ALIGNMENT. AFTER BENDING THE TIP OF THE DEVICE DELIVERY SYSTEM, WE CONFIRMED THAT THE DEVICE FUNCTIONED PROPERLY OUTSIDE THE BODY AND PROCEEDED WITH DEPLOYMENT. DURING DEPLOYMENT OF THE LEFT ATRIAL DISC, A COMPLETE FRACTURE OF THE DEVICE SHAFT OCCURRED. THE DEVICE COULD NOT MAINTAIN ITS SHAPE AND BENT SHARPLY. TO REINSERT THE DEVICE, A 12 FR SHEATH WAS INSERTED INTO THE RIGHT JUGULAR VEIN, AND THE TIP OF THE DEVICE WAS GRASPED USING A SNARE. THE SNARE WAS PULLED SUPERIORLY TO STRAIGHTEN THE BROKEN DEVICE. A SECOND SNARE WAS THEN USED TO PULL THE FRACTURED SHAFT TOWARD THE MAIN BODY OF THE DEVICE, ENABLING THE BROKEN PART TO BE INSERTED INTO THE SHEATH. AFTER SUCCESSFULLY RETRIEVING THE BROKEN DEVICE, A 27 MM OCCLUTECH® FIGULLA FLEX II SEPTAL OCCLUDER WAS IMPLANTED. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED 3 DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202360 GORE® CARDIOFORM ASD OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention