GORE CARDIOFORM ASD Occluder ASD32ARecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00733132636495), received between Jun 9, 2020 and Apr 17, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjuryApr 17, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT AN 11-YEAR-OLD FEMALE UNDERWENT ATRIAL SEPTAL DEFECT CLOSURE ON (B)(6), 2025, USING A 32 MM GORE® CARDIOFORM ASD OCCLUDER. POSTOPERATIVELY, THE PATIENT BEGAN EXPERIENCING DIZZINESS AND NEAR-SYNCOPE, WHICH HAVE PROGRESSIVELY INCREASED IN FREQUENCY. A FIRST-DEGREE ATRIOVENTRICULAR (AV) BLOCK WAS NOTED POST-PROCEDURE BUT HAS SINCE RESOLVED. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED AND EVALUATED FOR MRI WITHOUT CONTRAST. CONCERNS REGARDING MRI SAFETY, INCLUDING POTENTIAL DEVICE MOVEMENT AND/OR HEATING, WERE RAISED BY THE PATIENT¿S GUARDIANS. AS A RESULT, A DECISION WAS MADE TO FOREGO MRI EVALUATION ON (B)(6), 2026. THE FIRST-DEGREE AV BLOCK WAS TREATED WITH A SHORT COURSE OF STEROIDS.

  Patient problems: Arrhythmia

  MAUDE report 24915143 ↗
• InjuryApr 14, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED; THE PHYSICIAN SELECTED A 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. THE DEVICE CROSSED THE DEFECT ON A GUIDEWIRE AND WAS PLACED IN THE DEFECT WITH MINIMAL SHUNT. AFTER LOCKING, THE SHUNT WAS MORE PRONOUNCED, AND THE PHYSICIAN DECIDED TO REMOVE THE DEVICE FOR UPSIZING. THE PHYSICIAN FELT TENSION WHILE TRYING TO RECAPTURE THE DEVICE WITH THE RETRIEVAL CORD. THE DEVICE WAS PULLED DOWN TO THE INFERIOR VENA CAVA TO AID IN RECAPTURE. AS MORE PRESSURE WAS APPLIED, THE RETRIEVAL CORD BROKE AND THE DEVICE EMBOLIZED. THE EMBOLIZED OCCLUDER WAS REMOVED WITH A SNARE FROM THE RIGHT ILIAC VEIN. ON INSPECTION, THE TIP OF THE DELIVERY CATHETER WAS KINKED AT THE GUIDEWIRE PORT. A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED WITH NO ISSUES. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 24872382 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS REVIEWED FOLLOWING THE SURGERY AND IT APPEARED THAT PART OF THE DEVICE SHIFTED INTO THE LEFT ATRIUM AND A 3-4MM COLOR JET WAS NOTED. THE PHYSICIAN DECIDED TO LEAVE THE DEVICE IMPLANTED AND CONTINUE TO MONITOR THE PATIENT.

  Patient problems: Pericardial Effusion

  MAUDE report 23878310 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 32MM GORE® CARDIOFORM ASD OCCLUDER IN AN OFF-LABEL PROCEDURE TO CLOSE A MITRAL PERAVALVULAR LEAK. THE 32MM DEVICE WAS ADVANCED TO THE MITRAL VALVE ON THE GUIDEWIRE. JUST AS THE DEVICE WAS ABOUT TO BE LOCKED, A PERICARDIAL EFFUSION WAS NOTED IN THE LEFT VENTRICLE. THE DEVICE WAS QUICKLY LOCKED, AND THE PATIENT WAS TREATED WITH A PERICARDIOCENTESIS AND TRANSFUSION, BUT THE PRESSURE KEPT DROPPING. A CARDIOVASCULAR SURGEON PERFORMED AN OPEN REPAIR OF THE EFFUSION, TO STABILIZE THE PATIENT. THE PATIENT IS RECOVERING, AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pericardial Effusion

  MAUDE report 23083558 ↗
• InjuryAug 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A 32MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT. LATER THAT DAY, THE PATIENT HAD A SLIGHT FEVER AND ON A FOLLOW-UP ECHO, AN ECHOGENIC MOTION WAS DETECTED ON THE RIGHT ATRIAL DISC OF THE OCCLUDER. THE PHYSICIAN IS TREATING IT AS A THROMBUS WITH AN ANTICOAGULANT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22686147 ↗
• InjuryMar 28, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. THE DEVICE WAS LOCKED BUT THEN SLIPPED THROUGH THE SEPTUM. WHILE REMOVING THE DEVICE WITH THE RETRIEVAL CORD, THE CORD BROKE CLOSE TO THE RIGHT EYELET. THE PATIENT WAS TAKEN TO SURGERY WHERE THE DEVICE WAS REMOVED FROM THE PULMONARY ARTERY. THE ASD WAS SURGICALLY CLOSED DURING THE SAME PROCEDURE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 21721303 ↗
• InjurySep 10, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 32MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT THAT BALLOON STOP FLOWED TO 18.5MM. ABSENT AORTIC RIM AND DEFICIENT SVC AND POSTERIOR RIM. THE SEPTAL LENGTH WAS 32MM. THE PHYSICIAN WAS ADVISED TO ABORT AND NOT ATTEMPT. THE PHYSICIAN DECIDED TO ATTEMPT TO PLACE A 32MM GCA. AFTER FIRST UNSUCCESSFUL DEPLOYMENT ATTEMPT, THE PHYSICIAN TRIED TO RE-SHEATH THE DEVICE INTO THE CATHETER AND RE-CROSS TO TRY AGAIN. THE LEFT DISC WAS UNABLE TO BE FULLY LOADED BACK INTO THE CATHETER. THE PHYSICIAN REDEPLOYED THE ENTIRE DEVICE AND ATTEMPTED TO RECAPTURE AGAIN. WHEN THE PHYSICIAN ATTEMPTED TO BRING THE DEVICE BACK INTO THE DELIVERY CATHETER THE 2ND TIME WITH THE SLIDER, THE DEVICE CAME OFF THE DELIVERY SYSTEM. THE PHYSICIAN REPORTEDLY DID NOT ACTIVATE THE LOCK MECHANISM IN ANY WAY NOR REMOVE THE RETRIEVAL CORD LOCK. THE DEVICE WAS NO LONGER ATTACHED TO THE RETRIEVAL CORD. THE DECISION WAS MADE TO SEND THE PATIENT TO SURGERY BECAUSE THE DEVICE WAS WEDGED IN THE TRICUSPID VALVE AND COULD NOT BE SNARED. THE PATIENT WAS STABLE AT THIS TIME. THE DEVICE WAS REMOVED DURING SURGERY AND A SURGICAL CLOSURE OF THE ASD WAS PERF

  Patient problems: Foreign Body Embolism

  MAUDE report 20185662 ↗
• InjuryFeb 22, 2024Migration; Migration

  IT WAS REPORTED TO GORE A 32MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT MEASURING 16MM STATIC AND BALLOON SIZED TO 18.5MM. AFTER SEVERAL DEPLOYMENTS THE PHYSICIAN LOCKED THE DEVICE AND THE DEVICE PROLAPSED ANTERIORLY AND SUPERIORLY INTO THE RIGHT ATRIUM. THE DECISION WAS MADE TO REMOVE THE DEVICE. UPON TRYING TO RECAPTURE THE DEVICE THE PHYSICIAN COULD NOT GET THE DEVICE TO RETRACT INTO THE DELIVERY SYSTEM. THE DEVICE APPEARED TO BE COAXIAL AND NO REASON IT SHOULD NOT BE ABLE TO BE RECAPTURED. AFTER SEVERAL MINUTES OF TRYING TO REMOVE THE DEVICE THE RETRIEVAL CORD BROKE. THE PHYSICIAN ATTEMPTED TO SNARE THE DEVICE AND IT ENDED UP EMBOLIZING TO THE PATIENT'S PULMONARY ARTERY. IT WAS REPORTED THE PATIENT REMAINED STABLE. THE CARDIAC SURGERY TEAM AT THAT POINT DECIDED THE PATIENT SHOULD GO TO THE OPERATING ROOM FOR A SURGICAL REPAIR. SURGERY WAS SUCCESSFUL AND THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body Embolism

  MAUDE report 18759996 ↗
• InjuryJul 10, 2023Entrapment of Device; Device Dislodged or Dislocated; Entrapment of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 32MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 18MM WITH A DEFICIENT POSTERIOR INFERIOR RIM. APPROXIMATELY 12 HOURS POST IMPLANT, THE DEVICE EMBOLIZED. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB TO RETRIEVE THE DEVICE; HOWEVER, THE DEVICE APPEARED TO BE ENTRAPPED WITHIN THE TRICUSPID VALVE AND THE PATIENT WAS SENT FOR SURGICAL DEVICE REMOVAL AND DEFECT CLOSURE. THE PATIENT WAS DOING WELL FOLLOWING SURGERY.

  Patient problems: Foreign Body Embolism

  MAUDE report 17286982 ↗
• InjuryJun 8, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE PHYSICIAN SELECTED A 32MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT WITH A STATIC SIZE OF 12.5MM AND BALLOON SIZED TO 17MM. THE DEFECT HAD NO RETRO AORTIC RIM AND THE SEPTAL LENGTH WAS 27-30MM. THE DEVICE WAS INSERTED THROUGH A10F INTRODUCER SHEATH AND FLUOROSCOPY WAS USED TO IMAGE DEVICE ADVANCEMENT TO THE DEFECT. THE DELIVERY SYSTEM REPORTEDLY BUCKLED IN THE INFERIOR VENA CAVA (IVC). THE DELIVERY SYSTEM WAS REMOVED AND A VENOGRAM WAS PERFORMED. THE DELIVERY SYSTEM WAS INSERTED AGAIN AND WAS ADVANCED WITHOUT ISSUE TO THE RIGHT ATRIUM. THE OCCLUDER WAS DEPLOYED AND POSITIONING WAS UNDER REVIEW ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY. AT THIS POINT, THE PATIENT BEGAN TO DESATURATE. THE DEVICE WAS COMPLETELY REMOVED. THERE WAS NO RETRO-PERITONEAL BLEED, AND NO PERFUSION AROUND HEART, BUT ANOTHER VENOGRAM SHOWED EXTRAVASATION OF THE IVC. AN ATRIUM ICAST STENT (7MM X 16MM X 120CM) WAS DEPLOYED TO TREAT THE EXTRAVASATION AND THE PATIENT STABILIZED. THE PROCEDURE WAS ENDED AND THE PATIENT WILL BE SENT FOR SURGICAL DEFECT CLOSURE AT A LATER DATE.

  Patient problems: Extravasation

  MAUDE report 17090370 ↗
• InjuryApr 12, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE A 15-16MM ATRIAL SEPTAL DEFECT. THE DEFECT HAD A DEFICIENT RETROAORTIC RIM. THE DEVICE WAS POSITIONED AND LOCKED, BUT AS SOON AS THE RETRIEVAL CORD WAS REMOVED, THE INFERIOR SIDE OF THE RIGHT DISC SLID INTO THE LEFT ATRIUM. A SNARE AND A 12FR SHEATH WERE USED TO RETRIEVE THE DEVICE. THE PHYSICIAN GRABBED WHAT WAS THOUGHT TO BE THE RIGHT EYELET AND BEGAN TO PULL THE DEVICE INTO THE SHEATH WHEN SHE FELT A ¿POP¿. THE LOCKING LOOP WAS STILL IN THE SHEATH, BUT THE DEVICE HAD EMBOLIZED TO THE LEFT ATRIUM. WITH MORE MANIPULATION, THE LOCKING LOOP ALSO PUSHED OUT OF THE SHEATH AND RESTED IN THE LEFT ATRIUM. A SNARE WAS USED TO REMOVE THE LOCKING LOOP AND THE SHEATH WAS UPGRADED TO A 14FR SHEATH. A BIOPSY CLAMP WAS USED TO GRAB ONE OF THE PETALS OF THE DEVICE, BUT THE PETAL BROKE OFF THE DEVICE AND WAS REMOVED. THE PHYSICIAN GRABBED ANOTHER PETAL, AND AGAIN THE PETAL BROKE OFF AND WAS REMOVED. THE DEVICE WAS THEN CAPTURED WITH A SNARE AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A NEW 37MM DEVICE WAS IMPLANTED AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 16725339 ↗
• InjuryMar 15, 2023Adverse 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, THE PHYSICIAN IMPLANTED A 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. THE DEVICE WAS PLACED AND LOCKED WITH NO ISSUES. THE PATIENT DEVELOPED A 1ST DEGREE HEART BLOCK. THE PATIENT WAS STARTED ON STEROIDS. THE PHYSICIAN DECIDED THAT THE DEFECT WOULD BEST BE CLOSED SURGICALLY. THE PATIENT WAS TAKEN TO SURGERY TO CLOSE THE DEFECT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Atrial Fibrillation

  MAUDE report 16547422 ↗
• InjuryFeb 6, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 32MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT ON (B)(6) 2022. AT THE TIME OF IMPLANT THE DEVICE WAS WELL SEATED WITH NO ISSUES REPORTED. AT A FOLLOW-UP, THE PATIENT PRESENTED WITH SIGNIFICANT MITRAL REGURGITATION. IMAGING DID NOT CONFIRM DEVICE INTERFERENCE WITH THE VALVES. THE DEVICE WAS EXPLANTED ON (B)(6) 2023. AT THE TIME OF SURGICAL REMOVAL, THE DEVICE APPEARED NORMAL. THE DEFECT WAS CLOSED WITH A PATCH AND THE VALVES APPEARED TO LINE UP BETTER. THE PHYSICIAN WAS NOT SURE IF THE DEVICE LED TO THE MITRAL REGURGITATION OR IF IT WAS THE RIGHT HEART SIZE CHANGE AFTER DEFECT CLOSURE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16309082 ↗
• InjurySep 15, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO GORE A 32MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT. THE DEFECT MEASURED 15MM X 16MM STATIC, STOP FLOW BALLOON 20MM ONLY IN AP, SEPTAL LENGTH MAXIMUM 35MM. RIMS IVC 4MM, AO 5MM, AND SVC 7MM. IT WAS REPORTED THE PHYSICIAN SELECTED A 9FR TERUMO SHEATH. NO GUIDEWIRE WAS USED. THE DEVICE WAS DEPLOYED, HOWEVER, PROLAPSED INTO THE LEFT ATRIUM WHILE STILL ATTACHED TO THE RETRIEVAL CORD. THE PHYSICIAN REPORTED DIFFICULTY RECAPTURING THE DEVICE INTO THE SHEATH. THE DEVICE WAS ABLE TO BE BROUGHT BACK TO THE RIGHT ATRIUM, BUT THE PHYSICIAN WAS STILL UNABLE TO RECAPTURE IT INTO THE SHEATH. ADDITIONAL ACCESS WAS OBTAINED THROUGH THE LEFT GROIN USING A 13FR LONG SHEATH TO ATTEMPT TO SNARE THE DEVICE FROM THE TOP; HOWEVER, THIS WAS UNSUCCESSFUL. ADDITIONAL ACCESS THROUGH THE RIGHT JUGULAR WAS OBTAINED USING A 14FR SHEATH AND THE DEVICE WAS ABLE TO BE SNARED AND REMOVED. IT WAS REPORTED THAT THE PROCEDURE TIME WAS APPROXIMATELY EIGHT HOURS, DURING WHICH THE PATIENT BECAME HYPOXIC WITH LOW SATURATIONS, HEART RATE AND HYPOTENSIVE AND RECEIVED A BLOOD TRANSFUSION OF 271CC OF PRBC'S. EXCESSIVE ACCESS SITE BLEEDING WAS REPORTED. IT WAS ALSO REPORTE

  Patient problems: Bradycardia; Hemorrhage/Blood Loss/Bleeding; Hypoxia; Low Blood Pressure/ Hypotension

  MAUDE report 15427394 ↗
• InjuryJul 25, 2022Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 32 MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. THE DEFECT MEASURED 13-15 MM. THE DEVICE WAS PLACED AND LOOKED GOOD ON FLUOROSCOPY BUT IMAGING WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS VERY POOR. THE DEVICE WAS REPOSITIONED SEVERAL TIMES. THE TEE IMAGES WERE NOT GOOD ENOUGH TO GET A GOOD VIEW, SO THE PROBE WAS SWITCHED FOR A LARGER ONE. THE DEVICE WAS REMOVED AND RE-FLUSHED AND BEFORE IT WAS ATTEMPTED AGAIN, A PERICARDIAL EFFUSION WAS NOTED. A PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 60 CC¿S OF BLOOD WHICH WAS AUTO-TRANSFUSED BACK TO THE PATIENT. THE EFFUSION STABILIZED AND THE CASE WAS ABANDONED. THE PATIENT WILL BE REASSESSED FOR DEVICE CLOSURE AT A LATER DATE.

  Patient problems: Pericardial Effusion

  MAUDE report 15094784 ↗
• InjuryApr 7, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 32MM GORE® CARDIOFORM ASD OCCLUDER. THE DEVICE WAS DEPLOYED AND RECAPTURED AND LOCKED, BUT DUE TO A RESIDUAL SHUNT IT WAS DECIDED TO REMOVE THE DEVICE. WHILE REMOVING WITH THE RETRIEVAL CORD, THE EPTFE LOOP BROKE. THE RETRIEVAL CORD WAS STILL INTACT. ABOUT 90% OF THE DEVICE WAS RECAPTURED INTO THE DELIVERY CATHETER WHEN THE LOOP BROKE. THE PHYSICIAN CHOSE TO SEND THE PATIENT TO SURGERY FOR DEFECT CLOSURE AND TO REMOVE THE DEVICE AND, ENSURE THAT IT DID NOT EMBOLIZE DURING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14042658 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE PHYSICIAN IMPLANTED A 32MM GORE® CARDIOFORM ASD OCCLUDER ON (B)(6)2021, TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). THE DEVICE WAS IMPLANTED WITH NO ISSUES. AT A TWO-WEEK FOLLOW-UP ECHOCARDIOGRAPHY, THE DEVICE WAS IN GOOD POSITION WITH NO THROMBUS. ON (B)(6) 2021 A PEDUNCULATED THROMBUS WAS NOTED ON THE INFERIOR EDGE OF THE RIGHT DISC. THE DEVICE REMAINS IN GOOD POSITION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A HYPERCOAGULABLE WORK UP. ON (B)(6) 2021, THE PATIENT WAS STARTED ON LOVENOX. ON (B)(6) 2022, THE DEVICE WAS VISUALIZED WITH NO RESIDUAL SHUNT, OR OBSTRUCTION TO AV VALVES OR VENOUS RETURN. NO THROMBUS SEEN ON ECHO. LOVENOX WAS DISCONTINUED ON (B)(6) 2022. THE PATIENT WILL CONTINUE ON ASA FOR 6 MONTHS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13093763 ↗
• InjuryNov 2, 2021Retraction Problem; Material Separation; Migration; Retraction Problem; Material Separation; Migration

  IT WAS REPORTED THE PHYSICIAN SELECTED A 32MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 16MM X 17.5MM WITH A DEFICIENT SVC RIM. THE PATIENT HAD A TOTAL SEPTAL LENGTH OF 5CM. FOLLOWING DEVICE LOCKING, THE OCCLUDER SLIPPED OFF THE SVC RIM. WHEN ATTEMPTING TO RETRIEVE THE OCCLUDER, THE TIP OF THE CONTROL CATHETER KINKED, THE RETRIEVAL LOOP BROKE, AND THE DEVICE EMBOLIZED TO THE PULMONARY ARTERY. THE PHYSICIAN SUCCESSFULLY SNARED THE DEVICE FROM THE PATIENT AND A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED WITH NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737367 ↗
• InjuryJun 2, 2021Disconnection; Device Dislodged or Dislocated; Disconnection; Device Dislodged or Dislocated

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE A 15.5MM - 16.5MM STOP-FLOW BALLOON SIZED ATRIAL SEPTAL DEFECT. POSITIONING OF THE LEFT ATRIAL DISC WAS CHALLENGING DUE TO THE ORIENTATION OF THE DEFECT RESULTING IN MULTIPLE (3) DEVICE RECAPTURE ATTEMPTS. UPON THE FINAL DEPLOYMENT, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS ABLE TO SHOW CAPTURE OF RIM ANATOMY WITH NO RESIDUAL SHUNTING PER COLOR FLOW ANALYSIS. UPON LOCKING THE DEVICE, A DRAMATIC SHIFT IN DEVICE POSITION OCCURRED; RIGHT EYELET AND LOCK LOOP AT A 90 DEGREE ANGLE TO DISTAL CATHETER, AS WELL AS A CHANGE IN DEVICE APPEARANCE; EXTREMELY FLAT, DISC-ON-DISC. FLUOROSCOPIC EVIDENCE LEAD TO BELIEVE THE DEVICE HAD PROLAPSED OFF OF THE RIM ANATOMY AND THIS WAS CONFIRMED WITH TEE. WHILE REMOVING THE DEVICE WITH THE RETRIEVAL CORD THE DEVICE WAS BROUGHT DOWN INTO THE INFERIOR VENA CAVA AND WHILE ATTEMPTING TO PULL IT INTO THE INTRODUCER SHEATH THE RETRIEVAL CORD BROKE. THE DEVICE EMBOLIZED TO THE PATIENT¿S LEFT PULMONARY ARTERY. THE PHYSICIAN SNARED AND REMOVED THE EMBOLIZED DEVICE. A 37MM DEVICE WAS SELECTED AND IMPLANTED WITH NO DIFFICULTIES. THE PATIENT WAS DOING WELL FOLLOWING THE PROCE

  Patient problems: Embolism/Embolus

  MAUDE report 11921417 ↗
• InjuryDec 28, 2020Migration; Migration

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). THE DEFECT MEASURED 14MM BY STOP FLOW BALLOON SIZING. AT LOCK RELEASE, IT WAS NOTED THAT PART OF THE RIGHT DISC WAS DEPLOYED ON THE LEFT SIDE OF THE SEPTUM. THE PHYSICIAN HAD DIFFICULTY UNLOCKING THE DEVICE. A GREAT DEAL OF FORCE WAS APPLIED TRYING TO PULL THE DEVICE BACK INTO THE DELIVERY CATHETER. THE DELIVERY CATHETER KINKED AT THE GUIDEWIRE PORT. THE PTFE LOOP THAT THE RETRIEVAL CORD RUNS THROUGH, BROKE RELEASING THE ENTIRE SYSTEM FROM THE OCCLUDER. THE RETRIEVAL CORD DID NOT BREAK. THE DEVICE WAS VIEWED AGAIN AND LOOKED IN A STABLE POSITION ON THE SEPTUM WITH THE DEVICE STILL LOCKED. THE RETRIEVAL CORD WAS REMOVED AND A FEW MINUTES LATER THE DEVICE EMBOLIZED TO THE LEFT VENTRICLE. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE DEVICE AND REPAIR THE ASD.

  Patient problems: Embolism

  MAUDE report 11079913 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 32MM GORE® CARDIOFORM ASD OCCLUDER. THE DEVICE NOTED TO BE TOO LARGE FOR THE ANATOMY, SO IT WAS REMOVED. THE PHYSICIAN WAS GOING TO IMPLANT A SMALLER DEVICE BUT WHILE SWITCHING TO A NEW SHEATH, A PERICARDIAL EFFUSION WAS NOTED. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS AND THE PATIENT¿S VITALS STABILIZED. NO DEVICE WAS IMPLANTED, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 10437795 ↗
• InjuryAug 21, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 32MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE A CHALLENGING ATRIAL SEPTAL DEFECT (ASD). THE DEFECT MEASURED 17MM ON FLUOROSCOPY AND 15MM ON INTRACARDIAC ECHOCARDIOGRAPHY. THE DEVICE LOOKED WELL PLACED, SO WAS IMPLANTED AND LOCKED IN THE DEFECT. THE FOLLOWING MORNING, THE DEVICE HAD EMBOLIZED TO THE LEFT VENTRICLE. IT APPEARED TO BE CAPTURED IN THE CORDAL TISSUE OF THE MITRAL VALVE. THE PATIENT WAS SENT FOR SURGICAL REMOVAL OF THE DEVICE AND CLOSURE OF THE DEFECT. THE PROCEDURE WAS DONE LATER THE SAME DAY AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10437551 ↗
• InjuryJun 9, 2020Activation, Positioning or Separation Problem; Difficult to Open or Close; Activation, Positioning or Separation Problem; Difficult to Open or Close

  IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER (GSO) AND A 32MM GORE® CARDIOFORM ASD OCCLUDER (GCA) TO TREAT A MULTIFENESTRATED AND EXTREMELY ANEURYSMAL ATRIAL SEPTAL DEFECT. THE PATIENT WAS INTUBATED AND UNDER GENERAL ANESTHESIA. THE PROCEDURE PLAN WAS TO IMPLANT A 30MM GSO IN THE ANTERIOR DEFECT AND A 32MM GCA IN THE INFERIOR DEFECT. THE SELECTED 30MM GSO WAS DEPLOYED IN THE ANTERIOR DEFECT. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE 32MM GCA IN THE INFERIOR DEFECT BUT HAD DIFFICULTY FINDING OPTIMAL APPOSITION. IN AN ATTEMPT TO RECAPTURE THE DEVICE FOR REPOSITIONING, THE PHYSICIAN COULD NOT FULLY RELOAD THE LEFT ATRIAL DISC. THE DEVICE WAS REMOVED WITHOUT BEING FULLY RETRIEVED. ON THE BACK TABLE, THE PHYSICIAN COULD NOT GET THE DEVICE TO FORM CORRECTLY AND PLACED THE DEVICE ASIDE. A SECOND 32MM GCA WAS ADVANCED AND DEPLOYED; HOWEVER, THE DEVICE DID NOT FULLY COVER THE REMAINING DEFECTS. THIS DEVICE WAS RETRIEVED WITHOUT ISSUE. AT THIS POINT THE PHYSICIAN ALSO REMOVED THE 30MM GSO TO REASSESS THE FENESTRATIONS AND MAKE SURE THEY WERE IN THE CORRECT DEFECTS. THE LARGER DEFECTS WERE LOCATED AND BALLOON SIZED. THE PHYSICIAN THEN IMPLANTED THE 30MM GSO

  Patient problems: Infarction, Cerebral

  MAUDE report 10135805 ↗