GORE CARDIOFORM ASD Occluder ASD48ARecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00733132636525), received between Oct 6, 2020 and Sep 16, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (13 reports).

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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Positioning Problem; Migration

  Patient problems: Foreign Body Embolism

  MAUDE report 50793187 ↗
• InjuryMay 5, 2026Expulsion

  IT WAS REPORTED THE PHYSICIAN SELECTED A 48MM GORE® CARDIOFORM ASD OCCLUDER (S/N: (B)(6)) TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). AFTER DEPLOYMENT AND LOCKING, THE DEVICE PROLAPSED. THE DEVICE WAS REMOVED, AND THE PHYSICIAN SELECTED A SECOND 48MM GORE® CARDIOFORM ASD OCCLUDER (S/N:(B)(6)). THE SECOND DEVICE WAS SUCCESSFULLY DEPLOYED AND LOCKED; HOWEVER, LATER IN THE EVENING ON (B)(6), 2026, THE DEVICE EMBOLIZED. THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) FOR SURGICAL REMOVAL OF THE DEVICE AND SURGICAL CLOSURE OF THE ASD. PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 25083312 ↗
• InjuryMar 30, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). THE ASD WAS CROSSED WITH A GUIDEWIRE AND BALLOON SIZED TO APPROXIMATELY 25MM. THE DEVICE WAS ADVANCED AND DEPLOYED BUT KEPT SLIPPING OFF THE DEFECT. ON THE THIRD TRY THE DEVICE LOOKED STABLE AND WAS LOCKED AND RELEASED. ON ECHOCARDIOGRAPHY, A PERICARDIAL EFFUSION WAS NOTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE, AND THE EFFUSION HAD STOPPED. THE DEVICE WAS CHECKED AGAIN, BUT IT HAD SLIPPED OFF TWO OF THE RIMS. THE PHYSICIAN ELECTED TO REMOVE THE DEVICE OFF THE SEPTUM USING A SNARE AND BIOTOMES THROUGH THE 16FR SHEATH. THE PATIENT WILL HAVE SURGICAL CLOSURE OF THE ASD AT A LATER DATE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 24716085 ↗
• InjuryNov 24, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED ON (B)(6) 2025, THE PHYSICIAN IMPLANTED A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE 22X28MM ATRIAL SEPTAL DEFECT WITH A DEFICIENT INFERIOR RIM. THE DEVICE LOOKED IN GOOD POSITION AT THE END OF THE CASE AND AT PATIENT DISCHARGE. ON (B)(6) 2025, THE DEVICE WAS NOTED TO HAVE EMBOLIZED TO THE TRICUSPID VALVE AND WAS CAUGHT IN ONE OF THE LEAFLETS. THE DEVICE WAS REMOVED, AND THE ASD WAS CLOSED SURGICALLY. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE AND HAS SINCE BEEN DISCHARGED.

  Patient problems: Foreign Body Embolism

  MAUDE report 23631736 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. DURING THE PROCEDURE A PERICARDIAL EFFUSION WAS NOTED AFTER DEPLOYING THE DEVICE. THE PATIENT STARTED HAVING CHEST PAIN AND THE PRESSURE DROPPED. THE PATIENT WAS TREATED WITH A PERICARDIOCENTESIS AND GIVEN PROTAMINE TO REVERSE THE HEPARIN. THE PATIENT STABILIZED. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 23015460 ↗
• InjuryAug 18, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A 48MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT A 32MM ATRIAL SEPTAL DEFECT WITH GOOD RIMS. OVERNIGHT THE DEVICE EMBOLIZED TO THE MAIN PULMONARY ARTERY. THE DEVICE WAS REMOVED AND THE DEFECT CLOSED IN A SURGICAL PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 22829046 ↗
• InjuryMar 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 44MM GORE® CARDIOFORM ASD OCCLUDER ON (B)(6)2025. ON (B)(6)2025, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A FEVER OF 39.1 DEGREES CELSIUS. TRANSTHOACIC ECHOCARDIOGRAPHY SHOWED A THROMBUS ON THE RIGHT DISC. BLOOD CULTURES CAME BACK NEGATIVE. THE PATIENT WAS TREATED WITH A HEPARIN INFUSION AND PUT ON WARFARIN. THE DEVICE REMAINS IN GOOD POSITION AND THE PATIENT IS DOING WELL.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21682521 ↗
• InjurySep 18, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED TO GORE A 30MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT. THE DEVICE EMBOLIZED THE DAY AFTER IMPLANT. REPORTEDLY, THE DEVICE WAS IMPLANTED ON (B)(6) 2024, AND THE PROCEDURE WENT WELL. THE POSITION WAS CHECKED THE NIGHT OF THE 16TH AND WAS GOOD. THEN WHEN IT WAS CHECKED THE MORNING OF (B)(6) 2024, THE DEVICE HAD EMBOLIZED. THE PRE-OPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED THE DEVICE WAS TANGLED IN THE TRICUSPID. THE PHYSICIAN DID NOT ATTEMPT REMOVAL AND MADE THE DECISION TO SEND THE PATIENT TO HAVE THE DEVICE REMOVED SURGICALLY. AT THE TIME THE PATIENT WAS SENT TO SURGERY THEY WERE DOING WELL. IT WAS FURTHER REPORTED THAT THE PATIENT DID NOT HAVE DEFICIENT RIMS, AND THAT THE BLOOD PRESSURE WAS UP A BIT OVERNIGHT BUT NOTHING OF CONCERN. IT WAS ALSO REPORTED THEY HAD BALLOON STOP FLOW THAT MEASURED ON ECHO AT 25. THE 24 BALLOON MAXES OUT AT 27 MM AND A FULL VOLUME WAS PUT INTO THE BALLOON. THE DOCTOR OPTED TO TRY A 44 MM DEVICE FIRST. THAT DEVICE WOULDN'T STAY ON THE SUPERIOR AND OR ANTERIOR SUPERIOR RIM. WE THEN PLACED THE LARGER 48 MM DEVICE. THE PATIENT IS DOING WELL AFTER SURGERY.

  Patient problems: Foreign Body Embolism

  MAUDE report 20248970 ↗
• InjuryJul 26, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. RIGHT AFTER THE RETRIEVAL CORD WAS REMOVED, THE DEVICE SHIFTED, AND A SHUNT WAS PRESENT. THE PHYSICIAN DECIDED TO USE A SNARE TO REMOVE THE OCCLUDER. DURING THE ATTEMPT, THE OCCLUDER EMBOLIZED TO THE LEFT PULMONARY VEIN, WHERE IT WAS AGAIN SNARED AND BROUGHT DOWN TO THE INFERIOR VENA CAVA. THE OCCLUDER SLIPPED OFF THE SNARE AND MIGRATED TO THE RIGHT ATRIUM. THE PATIENT WAS SENT TO SURGERY WHERE THE OCCLUDER WAS REMOVED AND THE ASD WAS SURGICALLY CLOSED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 19837855 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. WHILE MANEUVERING THE DEVICE(RECAPTURED 3-5 TIMES), THE METAL HYPOTUBE BROKE DISTAL BUT WITHIN THE OCCLUDER. AT THIS POINT THE DEVICE WAS PULLED INTO THE RIGHT ATRIUM AND WAS STILL ATTACHED TO THE RETRIEVAL CORD. THE PHYSICIAN THEN GAINED ACCESS THROUGH THE NECK AND SNARED THE OCCLUDER WITH ATTACHED HYPOTUBE OUT, AND THE DELIVERY SYSTEM WAS REMOVED THROUGH THE GROIN. A 38MM AMPLATZER DEVICE WAS IMPLANTED, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. THE PHYSICIAN STATED THAT THE DELIVERY CATHETER WAS NOT SHAPED (BENT) BY THE PHYSICIAN BEFORE INSERTION INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300087 ↗
• InjuryDec 19, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED, THE PHYSICIAN IMPLANTED A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE A VERY COMPLEX ATRIAL SEPTAL DEFECT (ASD) WITH MULTIPLE DEFECTS. THE DEVICE WAS PLACED, LOCKED, AND RELEASED. SHORTLY AFTER THE RETRIEVAL CORD WAS REMOVED, THE DEVICE EMBOLIZED TO THE RIGHT VENTRICLE. 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 18360325 ↗
• InjuryNov 17, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED ON (B)(6) 2023, THE PHYSICIAN IMPLANTED A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE A 28-29MM ATRIAL SEPTAL DEFECT. THE IMPLANT WENT WELL WITH NO ISSUES. THE FOLLOWING DAY, AT THE DISCHARGE ECHOCARDIOGRAPHY, THE DEVICE WAS NOTED TO HAVE EMBOLIZED TO THE RIGHT VENTRICLE. THE DEVICE WAS REMOVED, AND THE DEFECT CLOSED IN A SURGICAL PROCEDURE THAT DAY. THE PATIENT WAS DOING WELL FOLLOWING THE SURGERY.

  Patient problems: Foreign Body Embolism

  MAUDE report 18158875 ↗
• InjuryOct 12, 2023Migration; Migration

  IT WAS REPORTED TO GORE A 48MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT. THE DEVICE WAS SUCCESSFULLY IMPLANTED; HOWEVER, LATER THE SAME DAY THE DEVICE EMBOLIZED. THE PATIENT WAS TAKEN BACK TO THE CATHETERIZATION LAB TO ATTEMPT REMOVAL OF THE DEVICE BY SNARING. THE PHYSICIAN WAS UNABLE TO SNARE THE DEVICE AND THE PATIENT WAS TAKEN TO SURGERY FOR DEVICE REMOVAL AND CLOSURE OF THE DEFECT.

  Patient problems: Foreign Body Embolism

  MAUDE report 17919829 ↗
• InjurySep 8, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). THE ASD MEASURED 27MM ON FLUOROSCOPY AND HAD A DEFICIENT RETROAORTIC AND SUPERIOR RIM. A 14FR SHEATH WAS ADVANCED TO THE OPENING OF THE RIGHT ATRIUM. THE DEVICE WAS DEPLOYED TWICE, BUT EACH TIME THE LEFT DISC PULLED THROUGH THE DEFECT. THE DEVICE WAS REMOVED, RE-FLUSHED AND THE CATHETER TIP WAS RESHAPED TO TRY TO GET A BETTER ANGLE. THE DEVICE WAS ADVANCED AGAIN TO THE DEFECT BUT AFTER 3 MORE ATTEMPTS WITH THE LEFT DISC PROLAPSING, THE PHYSICIAN CHOSE TO ABORT THE CASE. A PERICARDIAL EFFUSION WAS NOTED. THE PATIENT¿S PRESSURES DROPPED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WENT INTO CARDIAC ARREST AND WAS STABILIZED. THE PATIENT WAS TAKEN TO SURGERY TO FIND AND REPAIR THE PERFORATION AND CLOSE THE ASD. A HOLE IN THE ROOF OF THE LEFT ATRIUM WAS NOTED DURING SURGERY. UPDATE: PATIENT WAS DOING WELL POST SURGERY.

  Patient problems: Pericardial Effusion

  MAUDE report 17713331 ↗
• InjuryJun 30, 2023Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 48MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. LATER THAT EVENING THE DEVICE EMBOLIZED. THE NEXT DAY, THE DEVICE WAS REMOVED IN AN ADDITIONAL TRANSCATHETER PROCEDURE, AND THE DEFECT WAS CLOSED SURGICALLY. THE PATIENT WAS DOING WELL POST SURGERY.

  Patient problems: Foreign Body Embolism

  MAUDE report 17238659 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE A 48MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT. THE DEVICE SLIPPED OFF THE SEPTUM AND WAS REMOVED DUE TO THE APPOSITION ISSUE. A SECOND 48MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED AND IMPLANTED. IT WAS REPORTED THAT AFTER A COUPLE OF HOURS POST IMPLANT, ECHOCARDIOGRAM SHOWED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE EFFUSION; HOWEVER, SEVERAL HOURS LATER THE EFFUSION RETURNED AND THE PATIENT WAS TAKEN FOR SURGICAL REPAIR. IT WAS REPORTED THE DEVICE REMAINS IMPLANTED THE PATIENT IS DOING WELL.

  Patient problems: Pericardial Effusion

  MAUDE report 16112744 ↗
• InjuryDec 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 37MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE A 20MM ATRIAL SEPTAL DEFECT. THE ASD WAS CREATED IN A FAILED MITRAL CLIP PROCEDURE A FEW DAYS BEFORE. THE 37MM DEVICE WAS PLACED BUT PULLED THROUGH THE DEFECT, SO THE DEVICE WAS REMOVED. A 48MM CARDIOFORM DEVICE WAS ADVANCED AND LOCKED IN THE DEFECT. WHILE INTRODUCER SHEATH ACCESS WAS STILL IN PLACE, THE DEVICE EMBOLIZED TO THE TRICUSPID VALVE. THE PHYSICIAN AT FIRST WAS PLANNING ON REMOVING THE DEVICE TRANSCATHETERLY, BUT THE DEVICE WAS MOVING SO MUCH ON THE TRICUSPID VALVE THAT THEY DECIDED THAT IT WOULD BE BETTER TO REMOVE THE DEVICE, CLOSE THE ASD AND REPAIR THE MITRAL VALVE IN A SURGICAL PROCEDURE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 15982861 ↗
• InjuryOct 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A 48MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED ON (B)(6) 2022 TO TREAT AN ATRIAL SEPTAL DEFECT. THE PATIENT HAS SINCE DEVELOPED ATRIAL FIBRILLATION AND THE PATIENT WAS PRESCRIBED AMIODARONE FOR TREATMENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 15679910 ↗
• InjuryDec 13, 2021Migration; Migration

  IT WAS REPORTED THE PHYSICIAN SELECTED A 48MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 30-32MM. FOLLOWING DEPLOYMENT, BOTH FLUOROSCOPIC AND TRANSESOPHAGEAL (TEE) IMAGING SHOWED EQUAL DEPLOYMENT OF THE LEFT AND RIGHT DISCS ON THEIR RESPECTIVE SIDES OF THE SEPTUM. THE DEVICE WAS THEN LOCKED, AND AFTER FURTHER IMAGING REVIEW SHOWED THE DEVICE WELL POSITIONED, THE RETRIEVAL CORD WAS REMOVED. AFTER REMOVAL OF THE RETRIEVAL CORD THERE WAS SOME QUESTION ABOUT THE APPEARANCE OF ONE OF THE LEFT PETALS ON TEE, SO THE PHYSICIAN DECIDED TO FURTHER INTERROGATE USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE). BEFORE THE ICE CATHETER COULD BE ADVANCED INTO PLACE, THE DEVICE PROLAPSED COMPLETELY INTO THE RIGHT ATRIUM. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE WITH A SNARE; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL AS THE DEVICE HAD SHIFTED INTO THE TRICUSPID VALVE AND WAS SITTING IN BOTH THE RIGHT ATRIUM AND RIGHT VENTRICLE. THE PHYSICIAN FELT THAT DEVICE CLOSURE WAS NOT GOING TO BE POSSIBLE DUE TO THE PATIENT'S ANATOMY, SO A SURGEON WAS ALERTED AND THE DECISION WAS MADE TO TAKE THE PATIENT TO THE OPERATING ROOM FOR DEVICE REMOVAL AND SURGICAL DEFECT REPAIR. THE PHY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12991088 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 48MM GORE® CARDIOFORM ASD OCCLUDER ON (B)(6) 2021. AT A FOLLOW-UP APPOINTMENT ON (B)(6) 2021, A THROMBUS WAS NOTED WITHIN THE RIGHT DISC. THE PATIENT WAS TREATED WITH XARELTO AND WILL HAVE FOLLOW-UP IMAGING.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12413808 ↗
• InjuryJul 7, 2021Migration; Migration

  IT WAS REPORTED TO GORE A 48MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT. THE DEVICE WAS DEPLOYED AND LOCKED, HOWEVER, WHEN THE DELIVERY SYSTEM WAS BEING PULLED OUT, THE LOCK LOOP WAS STUCK IN THE SLOT OF THE CATHETER AND THE DEVICE EMBOLIZED TO THE INFERIOR VENA CAVA THEN BROKE FREE AND EMBOLIZED TO THE PULMONARY ARTERY. A 16FR SHEATH WAS PLACED AND THE DEVICE WAS SNARED, BUT AS IT WAS BEING BROUGHT DOWN INTO THE SHEATH IT BROKE FREE AND EMBOLIZED AGAIN TO THE PULMONARY ARTERY. A 24FR SHEATH WAS PLACED AND THE DEVICE WAS SUCCESSFULLY SNARED AND REMOVED. THE PATIENT WAS REPORTED TO BE DOING WELL AND WAS TO BE DISCHARGED THE SAME DAY. THE PATIENT WILL BE BROUGHT BACK AT A FUTURE DATE FOR CLOSURE OF THE DEFECT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12127651 ↗
• InjuryMar 29, 2021Migration; Migration

  IT WAS REPORTED THE PHYSICIAN SELECTED A 48MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 27MM (STATIC SIZING 24MM) IN A PATIENT WITH DEFICIENT RETRO AORTIC AND SUPERIOR RIMS. THE DEVICE WAS DEPLOYED, LOCKED, AND RELEASED WITHOUT ISSUE. TWO TO THREE MINUTES LATER, WHILE ASSESSING THE DEVICE, IT EMBOLIZED INTO THE RIGHT ATRIUM. THE PHYSICIAN'S ATTEMPT TO SNARE THE DEVICE WERE UNSUCCESSFUL AND THE OCCLUDER MOVED INTO THE RIGHT VENTRICLE AND THEN TO THE RIGHT PULMONARY ARTERY. THE PATIENT WAS SENT DIRECTLY TO SURGERY FOR DEVICE REMOVAL AND SURGICAL DEFECT REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585763 ↗
• InjuryOct 6, 2020Migration; Migration

  IT WAS REPORTED TO GORE A 48MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED ON (B)(6) 2020 TO TREAT AN ATRIAL SEPTAL DEFECT. THE FOLLOWING DAY, (B)(6) 2020, THE DEVICE EMBOLIZED TO THE TRICUSPID VALVE. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF THE DEVICE AND SURGICAL CLOSURE OF THE DEFECT.

  Patient problems: No Code Available

  MAUDE report 10634639 ↗