GORE CARDIOFORM ASD Occluder ASD37ARecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00733132636501), received between Feb 12, 2020 and Sep 16, 2026 — classified as 41 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 21, 2022Class IIOpen, Classified

   Due to manufacturing records (Release Test Results) indicating "Failed".

   Z-0136-2023 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Device Dislodged or Dislocated; Migration

  It was reported; the physician implanted a 37mm GORE® CARDIOFORM ASD Occluder to close a 19-21mm Atrial Septal Defect with a deficient aortic rim. As the patient was being extabated, the patient started coughing and the device was noted to have embolized to the Pulmonary Artery. The device was removed with a snare and a new 44mm GORE® CARDIOFORM ASD Occluder was implanted. The patient was doing well following the procedure.

  Patient problems: Foreign Body Embolism

  MAUDE report 50792997 ↗
• InjuryAug 20, 2026Device Slipped; Material Split, Cut or Torn

  It was reported the physician selected a 37mm GORE® CARDIOFORM ASD Occluder to treat an atrial septal defect. The occluder was deployed and locked. The occluder then prolapsed and while attempting to retrieve the device the retrieval cord broke. The occluder embolized to the right pulmonary artery. A preliminary attempt to snare the device was unsuccessful and the occluder was ultimately retrieved with forceps and a 24Fr. catheter. A 48mm GORE® CARDIOFORM® ASD Occluder was implanted with no adverse effects. The patient was doing well following the procedure.

  Patient problems: Foreign Body Embolism

  MAUDE report 50358617 ↗
• InjuryFeb 26, 2026Difficult to Remove

  IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED TO IMPLANT A 32 MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). THE DEVICE WAS DETERMINED TO BE TOO SMALL FOR THE DEFECT AND WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 37 MM GORE® CARDIOFORM ASD OCCLUDER. DURING THIS ATTEMPT, A RESIDUAL SHUNT WAS OBSERVED. AS THE PHYSICIAN ATTEMPTED TO UNLOCK THE DEVICE, THE DEVICE PULLED THROUGH THE SEPTUM. IT WAS ALSO NOTED THAT THE DELIVERY CATHETER BECAME KINKED DURING THE UNLOCKING ATTEMPT. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS THEN INSERTED TO ASSIST WITH CAPTURING THE 37 MM DEVICE. WHILE ATTEMPTING RETRIEVAL, THE BIOTOME HANDLE BROKE WHEN THE OCCLUDER DEVICE WAS HALFWAY INTO A 14 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WITH THE BIOTOME STILL ATTACHED. THE PHYSICIAN RELEASED THE OCCLUDER DEVICE, EXCHANGED THE CARDIOFORM DELIVERY SYSTEM, PLACED ANOTHER GORE® DRYSEAL FLEX INTRODUCER SHEATH, AND ATTEMPTED RETRIEVAL USING AN ONO SYSTEM. WHEN THIS WAS UNSUCCESSFUL, THE OCCLUDER DEVICE WAS ULTIMATELY REMOVED USING LARGER FORCEPS (ALLIGATOR CLIP). AN ANGIOGRAM REVEALED BLEEDING AND DAMAGE TO THE INFERIOR VENA CAVA (IVC). A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462170 ↗
• InjuryDec 17, 2025Migration; Migration

  IT WAS REPORTED THAT A 37 MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT (ASD) WITH A SEVERELY DEFICIENT RIM. FOLLOWING THE PROCEDURE, A POSTOPERATIVE X-RAY REVEALED THAT THE DEVICE HAD EMBOLIZED. THE PATIENT WAS SUBSEQUENTLY TAKEN TO SURGERY FOR DEVICE RETRIEVAL AND OPEN REPAIR OF THE ASD. THE PHYSICIAN BELIEVES THE EMBOLIZATION OCCURRED DUE TO THE PATIENT¿S ANATOMY. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Foreign Body Embolism

  MAUDE report 23829470 ↗
• InjurySep 9, 2025Material Separation; Device Slipped; Deformation Due to Compressive Stress; Material Separation; Device Slipped; Deformation Due to Compressive Stress

  IT WAS REPORTED THE PHYSICIAN SELECTED A 37MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT MEASURE TO 18MM. INITIAL DEPLOYMENT RESULTED IN PARTIAL DEVICE PROLAPSE, SO THE THE DEVICE WAS REPOSITIONED WITH GOOD RESULTS. AFTER DEVICE LOCKING, A RESIDUAL SHUNT WAS OBSERVED SO THE PHYSICIAN CHOSE TO RETRIEVE THE DEVICE. DURING DEVICE RETRIEVAL, THE DELIVERY CATHETER KINKED AND THE RETRIEVAL CORD SLIPPED OUT OF RETRIEVAL CORD LOCK. THE PHYSICIAN MADE NUMEROUS ATTEMPTS TO SNARE THE DEVICE BUT WAS UNSUCCESSFUL. THE DEVICE WAS LEFT IN THE PATIENT AND A SURGICAL PROCEDURE FOR DEVICE EXPLANT AND DEFECT CLOSURE WAS SCHEDULED. POST PROCEDURE IMAGING ON (B)(6) 2025 SHOWED NO EFFUSION OR INJURY TO THE PATIENT, WHO IS CURRENTLY IN STABLE CONDITION. THE PHYSICIAN NOTED THE ANEURYSMAL SEPTUM LIKELY WRAPPED AROUND THE CENTER OF THE DEVICE WHICH PREVENTED THE OCCLUDER FROM BEING RETRIEVED VIA TRANSCATHETER. THE DEVICE WAS EXPLANTED AND THE SEPTAL DEFECT WAS SURGICALLY CLOSED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999864 ↗
• InjuryJul 8, 2025Expulsion; Expulsion

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 37 MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. IT WAS FURTHER REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT HAD A COUGHING EPISODE AND IT WAS NOTED THE OCCLUDER EMBOLIZED. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB, THE OCCLUDER WAS REMOVED VIA SNARE, AND A NEW 37 MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED WITH NO REPORTED ISSUES. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 22437442 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 37 MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS IMPLANTED ON (B)(6), 2025, TO TREAT AN ATRIAL SEPTAL DEFECT. THE IMPLANT PROCEDURE WAS UNEVENTFUL. HOWEVER, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGE REPORTEDLY REVEALED A LARGE LEFT ATRIAL CLOT ATTACHED TO THE DEVICE. THE PATIENT IS NOW EXPECTED TO UNDERGO OPEN HEART SURGERY ON (B)(6), 2025. THE PATIENT HAS BEEN REPORTED AS DOING WELL AFTER SURGERY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22199587 ↗
• InjuryMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 37MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN 18MM ATRIAL SEPTAL DEFECT. AFTER THE DEVICE WAS LOCKED, A SHUNT WAS STILL PRESENT. WHILE REMOVING THE DEVICE WITH THE RETRIEVAL CORD, THE CORD BROKE. THE DEVICE EMBOLIZED TO THE RIGHT ATRIUM. THE DEVICE WAS REMOVED USING TWO SNARES, ONE FROM THE INTERNAL JUGULAR AND ONE FROM THE GROIN. THE DEVICE WAS GRABBED FROM BOTH ENDS TO STRETCH IT OUT AND REMOVED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 22119073 ↗
• InjuryNov 5, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 37MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. THE DEVICE COULD NOT FULLY CAPTURE THE SUPERIOR RIM, SO IT WAS DECIDED TO REMOVE THE DEVICE. THE ANGLE MADE IT DIFFICULT TO RECAPTURE THE DEVICE, AND IT CAUGHT ON THE TIP OF THE DELIVERY SYSTEM, BREAKING THE RETRIEVAL CORD. THE DEVICE EMBOLIZED INTO THE RIGHT VENTRICLE. THE DEVICE WAS THEN SNARED OUT OF THE PULMONARY ARTERY. A NEW 44MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED WITH NO ISSUES. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 20615969 ↗
• InjuryMay 20, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 37MM GORE® CARDIOFORM ASD OCCLUDER. AFTER THE DEVICE WAS LOCKED IT WAS NOTED TO BE UNDERSIZED FOR THIS DEFECT. WHILE REMOVING THE DEVICE WITH THE RETRIEVAL CORD, THE CORD BROKE. THE DEVICE WAS REMOVED WITH A SNARE FROM THE LEFT ATRIUM. THE DEFECT WAS BALLOON SIZED AGAIN. A 38MM ASO DEVICE WAS IMPLANTED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 19352229 ↗
• InjuryMar 28, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO GORE A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO REPAIR A 13-18 MM RANGE ATRIAL SEPTAL DEFECT BY THE PHYSICIAN. UPON DEPLOYMENT, THE LEFT DISC APPEARED TO BE COMPRESSED. THE DISC WAS RE-SHEATHED AND DEPLOYMENT WAS ATTEMPTED AGAIN. THE DISK STILL APPEARED COMPRESSED SO THE DEVICE WAS REMOVED, SHEATHED, AND UNSHEATHED ON THE TABLE, AND IT APPEARED NORMAL. AT THIS TIME THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION AND WAS SENT TO SURGERY WHERE THE PATIENT MADE A FULL RECOVERY. IT WAS NOTED THAT THERE WAS A SMALL TEAR IN THE BASE OF LEFT ATRIAL APPENDAGE (LAA), THAT MAY HAVE HAPPENED DURING THE PROCEDURE. IT WAS FURTHER REPORTED THE PHYSICIAN FIRST DRAINED THE EFFUSION AND DECIDED IT WAS BETTER FOR THE PATIENT TO REPAIR THE EFFUSION AND ASD SURGICALLY. THE PHYSICIAN BELIEVED THE DEVICE MOVED TOWARD THE LAA WHEN UNSHEATHING OR REPOSITIONING THE DEVICE AND THAT MAY HAVE CAUSED THE TEAR AT THE BASE OF THE LAA. THERE ARE NO IMAGES AVAILABLE AND THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Pericardial Effusion

  MAUDE report 19000189 ↗
• InjuryJan 31, 2024Migration; Migration

  IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A PATENT FORAMEN OVALE. DURING DEPLOYMENT, THE OCCLUDER PULLED THROUGH THE DEFECT AND WAS REMOVED. THE PHYSICIAN THEN SELECTED A 37MM GORE® CARDIOFORM ASD OCCLUDER. THE DEVICE WAS DEPLOYED AND LOCKED. THE OCCLUDER APPEARED STABLE AND WAS SUBSEQUENTLY RELEASED. DURING DEVICE ASSESSMENT, THE OCCLUDER SLIPPED OFF THE SEPTUM INTO THE LEFT ATRIUM AND EMBOLIZED TO THE DESCENDING AORTA. THE OCCLUDER WAS SNARED WITHOUT ISSUE. AT THIS POINT, THE PHYSICIAN TOOK SOME DEFECT MEASUREMENTS WITH ECHOCARDIOGRAPHY, AND A 48MM GORE® CARDIOFORM ASD OCCLUDER WAS THEN IMPLANTED WITH NO ADVERSE EFFECTS.

  Patient problems: Foreign Body Embolism

  MAUDE report 18620019 ↗
• InjuryJan 19, 2024Break; Entrapment of Device; Difficult to Remove; Break; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED TO GORE A 37MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT. AFTER THE DEVICE WAS DEPLOYED AND LOCKED IT WAS REPORTED THAT IT APPEARED THAT A PORTION OF THE RIGHT ATRIAL DISC WAS JUTTING INTO THE SUPERIOR VENA CAVA. THE PHYSICIAN TRIED TO ADVANCE A BALLOON TO TRY AND MOVE THE RIGHT ATRIAL DISC INTO THE CORRECT POSITION; HOWEVER, THIS WAS UNSUCCESSFUL. THE PHYSICIAN THEN TRIED TO RETRIEVE THE DEVICE BUT AS THE RIGHT DISC WAS BEING BROUGHT BACK INTO THE CATHETER THE RETRIEVAL CORD BROKE. THE PHYSICIAN THEN TRIED TO SNARE THE DEVICE BUT WAS UNSUCCESSFUL AS IT APPEARED AS THOUGH THE LEFT ATRIAL DISC WAS LODGE IN THE INFERIOR VENA CAVA CAUSING WHAT APPEARED TO BE A PERFORATION OF THE INFERIOR VENA CAVA. FURTHER ATTEMPTS TO REMOVE THE DEVICE WERE STOPPED AS THE PATIENT BECAME UNSTABLE AND WAS TAKEN TO SURGERY. IT WAS REPORTED THERE WAS A RETRO-PERITONEAL BLEED DUE TO THE INJURY. A LONG OPEN ABDOMINAL APPROACH WAS NEEDED TO REMOVE THE DEVICE AND TREAT THE PERITONEAL AREA. THE PATIENT REMAINS IN THE INTENSIVE CARE UNIT.

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 18547058 ↗
• InjuryDec 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 37MM GORE® CARDIOFORM ASD OCCLUDER ON (B)(6) 2023. AT A FOLLOW-UP APPOINTMENT ON (B)(6) 2023, THE PATIENT COMPLAINED OF MIGRAINE HEADACHES AND A THROMBUS WAS NOTED ON THE RIGHT DISC. THE PHYSICIAN CONSIDERED ASPIRATION TO REMOVE THE THROMBUS, BUT ULTIMATELY CHOSE TO REMOVE THE DEVICE. A SURGICAL PROCEDURE WAS DONE ON (B)(6) 2023 TO REMOVE THE DEVICE AND CLOSE THE DEFECT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Headache; Thrombosis/Thrombus

  MAUDE report 18352488 ↗
• InjuryJul 31, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED, THE PHYSICIAN IMPLANTED A 37MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ANEURYSMAL 23MM PATENT FORAMEN OVALE(PFO). THE PFO HAD A LONG, 35MM TUNNEL. THE DEVICE LOOKED WELL PLACED AND WAS LOCKED AND RELEASED. A FEW MINUTES LATER, WHILE THE PHYSICIAN WAS STILL DOING A BUBBLE STUDY, THE DEVICE EMBOLIZED TO THE RIGHT VENTRICLE. THE OCCLUDER WAS REMOVED WITH A SNARE WITH NO ISSUES. THE PATIENT WILL BE REFERRED FOR SURGICAL CLOSURE AT A LATER DATE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 17430468 ↗
• InjuryJul 6, 2023Migration; Migration

  IT WAS REPORTED TO GORE A 37M GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT. IT WAS REPORTED THE RETRIEVAL CORD BROKE DURING RETRIEVAL AND THE DEVICE EMBOLIZED TO THE RIGHT VENTRICLE. THE DECISION WAS MADE TO SURGICALLY REMOVE THE DEVICE AND CLOSE THE DEFECT AT THAT TIME. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Foreign Body Embolism

  MAUDE report 17266029 ↗
• InjuryJun 13, 2023Migration; Migration

  IT WAS REPORTED TO GORE A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT MEASURING APPROXIMATELY 20MM BY FLUOROSCOPY. THE DEVICE WAS DEPLOYED IN STANDARD FASHION. A DETAILED INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND FLUOROSCOPIC INTERROGATION SUGGESTED APPROPRIATE DEVICE POSITION AND FUNCTION AND THE RIGHT ATRIAL LOCKING LOOP WAS DEPLOYED. FURTHER ICE REVEALED FLOW AROUND THE SUPERIOR MARGIN OF THE DEVICE IN THE REGION OF THE SUPERIOR VENA CAVA WHICH WAS CONCERNING FOR INCOMPLETE CAPTURE OF THE SUPERIOR RIM. THE DEVICE WAS PULLED INTO THE DELIVERY SHEATH VIA THE RETRIEVAL CORD, HOWEVER, THE RIGHT ATRIAL EYELET FAILED TO FULLY PROLAPSE INTO THE END OF THE DELIVERY CATHETER AND WITH TENSION APPLIED THE RETRIEVAL CORD BROKE. THE DEVICE EMBOLIZED INTO THE LEFT ATRIUM AND BECAME LODGED, STRADDLING THE MITRAL VALVE ANNULUS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AT THIS TIME BUT DID DEVELOP RAPID ATRIAL FIBRILLATION WITH A HEART RATE OF APPROXIMATELY 100BPM. AT THIS TIME, ANESTHESIA WAS CALLED TO THE PATIENT'S BEDSIDE URGENTLY. A PROPOFOL DRIP FOLLOWED BY GENERAL ANESTHESIA WITH ENDOTRACHEAL TUBE WAS INITIATED. RIGHT FEMORAL ARTERIAL ACCESS WAS ESTABL

  Patient problems: Atrial Fibrillation; Foreign Body Embolism

  MAUDE report 17117110 ↗
• InjuryMay 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 37MM GORE® CARDIOFORM ASD OCCLUDER ON (B)(6) 2023. AT A FOLLOW-UP APPOINTMENT ON (B)(6) 2023, A SUSPECTED THROMBUS WAS NOTED ON THE RIGHT DISC. THE PATIENT WAS TREATED WITH AN UNKNOWN ANTICOAGULANT. THE PATIENT WAS ALSO NOTED TO BE IN ATRIAL FLUTTER, AND WAS TREATED WITH BETA BLOCKERS.

  Patient problems: Atrial Flutter; Thrombosis/Thrombus

  MAUDE report 16860826 ↗
• InjuryMar 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 37MM GORE® CARDIOFORM ASD OCCLUDER ON (B)(6)2023. TWO DAYS FOLLOWING IMPLANT THE PATIENT COMPLAINED OF FEVER. ON (B)(6) 2023, AN ECHOGENIC MASS (SUSPECTED THROMBUS) WAS NOTED ON THE RIGHT DISC USING TRANSTHORACIC ECHOCARDIOGRAPHY. THE PATIENT WAS TREATED WITH AN UNKNOWN ANTICOAGULANT, AND BLOOD CULTURES WERE NEGATIVE. THE NEXT DAY, ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY THE THROMBUS WAS CONFIRMED ON THE RIGHT DISC AND A THROMBECTOMY WAS PERFORMED TO REMOVE THE THROMBUS. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16598513 ↗
• InjurySep 15, 2022Break; Difficult or Delayed Positioning; Device Dislodged or Dislocated; Migration; Break; Difficult or Delayed Positioning; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED, THE PHYSICIAN WAS IMPLANTING A 37MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE A 17MM ATRIAL SEPTAL DEFECT (ASD) WITH DEFICIENT RIMS. THE DEVICE WAS PLACED AND IN GOOD POSITION, EXCEPT IT WAS HITTING ON THE MITRAL VALVE. THE PHYSICIAN CHOSE TO REMOVE THE DEVICE. THE PHYSICIAN COULD NOT GET THE RIGHT DISC TO PULL INTO THE DELIVERY CATHETER. WITH FURTHER MANIPULATION, THE RETRIEVAL CORD BROKE. A SNARE WAS USED TO TRY TO CAPTURE THE DEVICE, BUT IT WAS DISLODGED OFF THE SEPTUM AND EMBOLIZED TO THE PULMONARY ARTERY. THE DEVICE WAS SNARED, AND PART OF THE DEVICE WAS ABLE TO BE CAPTURED INTO A 16 X 65 SHEATH. A BALLOON WAS USED TO PULL THE DEVICE 85% OF THE WAY INTO THE SHEATH, BUT THE PHYSICIAN WAS NOT ABLE TO PULL IT IN ANY FURTHER. THE PHYSICIAN DID NOT WANT TO PULL THE DEVICE WITH PART OF THE LEFT DISC HANGING OUT THROUGH THE VALVES AND OTHER VASCULATURE, SO THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE DEVICE AND REPAIR THE ASD. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 15428682 ↗
• InjuryMay 31, 2022Migration; Migration

  IT WAS REPORTED THE PHYSICIAN SELECTED A 37MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT MEASURED TO 20MM WITH AN ABSENT RETRO-AORTIC RIM. THE DEFECT WAS NOT BALLOON SIZED. THE DEVICE WAS DEPLOYED AND THE PHYSICIAN WAS NOT SATISFIED WITH THE RIGHT DISC APPEARANCE. THE DEVICE WAS RELOADED AND DEPLOYED AGAIN. ECHOCARDIOGRAPHY SHOWED THAT THE DEVICE APPEARED STABLE WITH NO RESIDUAL SHUNT AND THE PHYSICIAN DECIDED TO LOCK AND RELEASE THE OCCLUDER. LATER THE SAME EVENING, THE DEVICE EMBOLIZED TO THE SUPERIOR MESENTERIC ARTERY. THE DEVICE WAS SUCCESSFULLY REMOVED WITH A SNARE AND ANOTHER ATTEMPT AT DEVICE CLOSURE WILL BE MADE ON A LATER DATE. THE PATIENT WAS STABLE FOLLOWING DEVICE REMOVAL.

  Patient problems: Foreign Body Embolism

  MAUDE report 14553260 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED TO GORE A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED ON (B)(6) 2022 TO TREAT AN ATRIAL SEPTAL DEFECT. THE PHYSICIAN REPORTED ON (B)(6) 2022 THAT THE DEVICE HAD EMBOLIZED TO THE LEFT PULMONARY ARTERY. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT WAS TAKEN TO THE CATHETERIZATION LAB FOR RETRIEVAL OF THE DEVICE; HOWEVER, THE ATTEMPT TO RETRIEVE THE DEVICE WAS UNSUCCESSFUL AND THE PATIENT WAS TAKEN TO SURGERY. UPDATE PROVIDED FROM THE PHYSICIAN. THE PATIENT IS DOING FINE AFTER THE SURGERY.

  Patient problems: Foreign Body Embolism; Obstruction/Occlusion

  MAUDE report 13801891 ↗
• InjuryMar 4, 2022Migration; Migration

  IT WAS REPORTED THE PHYSICIAN SELECTED A 37MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT WITH A STATIC MEASUREMENT OF 23MM X 24MM (BALLOON SIZING WAS NOT PERFORMED) AND A SEPTAL LENGTH OF 34MM X 47MM. THE OCCLUDER WAS DEPLOYED AND LOCKED WITH GOOD SEPTAL APPOSITION. A MINOR RESIDUAL SHUNT WAS NOTED. THE FOLLOWING DAY, IMAGING SHOWED THE OCCLUDER HAD EMBOLIZED TO THE LEFT PULMONARY ARTERY. THIS DEVICE WAS SNARED AND A 44MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED WITH NO ADVERSE EFFECTS. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667066 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED ON (B)(6) 2021 TO TREAT AN ATRIAL SEPTAL DEFECT. ECHOCARDIOGRAM ON (B)(6) 2021 SHOWED A SMALL THROMBUS ON THE DEVICE. THE PATIENT WAS TREATED WITH XARELTO. FOLLOW-UP ECHOCARDIOGRAM ON (B)(6) 2022 SHOWED THE THROMBUS PRESENT AND SLIGHTLY LARGER IN SIZE. THE PATIENT IS TO START ON COUMADIN ON (B)(6) 2022.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13544307 ↗
• InjuryJan 12, 2022Break; Patient-Device Incompatibility; Device Dislodged or Dislocated; Break; Patient-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THE PHYSICIAN SELECTED A 37MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT. THE DEFECT HAD A STATIC MEASUREMENT OF 14-15MM AND WAS BALLOON SIZED TO 19MM. THE DEFECT MEASURED 20MM WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY. FOLLOWING DEVICE PLACEMENT AND LOCKING, A RESIDUAL SHUNT WAS NOTED. AS THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICE, THE RETRIEVAL CORD BROKE AND THE DEVICE EMBOLIZED INTO THE RIGHT ATRIUM NEAR THE TRICUSPID VALVE. THE PHYSICIAN USED A SNARE TO GRAB THE LEFT ATRIAL EYELET. AT THIS POINT IN RETRIEVAL, THE DEVICE EXTENDED AND THE LOCK LOOP APPEARED TO PULL THROUGH THE EYELETS. THE PHYSICIAN THEN USED A LARGER SHEATH TO RETRIEVE THE OCCLUDER WITHOUT ISSUE. A 20MM AMPLATZER DEVICE WAS THEN IMPLANTED WITH NO ADVERSE EFFECTS. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236323 ↗