GORE CARDIOFORM Septal Occluder GSX0030ARecalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00733132631032), received between Jun 28, 2018 and Sep 21, 2026 — classified as 138 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (25 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. Dec 14, 2022Class IIOpen, Classified

   Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.

   Z-1048-2023 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 143 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Difficult or Delayed Positioning

  It was reported the physician was implanting a 30mm GORE® CARDIOFORM Septal Occluder to close a long tunnel, aneurysmal Patent Foramen Ovale. Both disc did not oppose the septum well, so the device was repositioned twice. On the third attempt, the left disc prolapsed into the tunnel. The device was deployed again, and a shunt was still present. The device was removed in favor of trying a larger device. At this point, the patient became symptomatic and a Pericardial Effusion was noted in the superior portion of the left atrium. The patient was treated with a Pericardiocentesis. The patient was sent for surgical repair of the effusion and closure of the PFO. The patient was doing well following the surgery.

  Patient problems: Pericardial Effusion

  MAUDE report 50841333 ↗
• InjuryMay 22, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A LONG TUNNEL (11MM TUNNEL) PATENT FORAMEN OVALE. THE PHYSICIAN GAINED ACCESS ACROSS DEFECT WITHOUT ANY COMPLICATIONS. WIRE WAS PLACED IN THE LEFT UPPER PULMONARY VEIN. DURING DEPLOYMENT THE PHYSICIAN NOTED FEELING RESISTANCE. ECHOCARDIOGRAPHY SHOWED THE DEVICE WAS STILL IN THE LONG TUNNEL. THE DEVICE WAS RECAPTURED AND REPOSITIONED. DURING THE SECOND DEPLOYMENT ATTEMPT THE LEFT DISC FORMED COMPLETELY. HOWEVER, DURING DEPLOYMENT OF THE RIGHT DISC, IT PROLAPSED IN A LAO/CRAN POSITION. THE RIGHT DISC WAS THEN RECAPTURED, ROTATED POSTERIORLY AND REDEPLOYED. A THIRD DEPLOYMENT ATTEMPT WAS PERFORMED BY PULLING THE LEFT DISC BACK ONTO THE SEPTUM SHOWING ADEQUATE CUPPING FOLLOWED BY FULL DEPLOYMENT OF THE RIGHT DISC. AT THIS TIME, THE RIGHT DISC APPEARED FLUSH WITH THE SEPTUM AND DIAMETER WAS SIMILAR TO LEFT DISC. THE DEVICE WAS THEN LOCKED AND RELEASED. SUBSEQUENT EVALUATION WITH ICE IMAGING IDENTIFIED A PERICARDIAL EFFUSION MEASURING APPROXIMATELY 8 MM. THE PATIENT REMAINED IN NORMAL SINUS RHYTHM WITH BLOOD PRESSURE AT 112/60 MMHG BUT BECAME DIAPHORETIC. A PERICARDIOCENTESIS WAS PERFORMED, WITH APPRO

  Patient problems: Pericardial Effusion

  MAUDE report 25257572 ↗
• InjuryMay 5, 2026Malposition of Device

  IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE. THE DEVICE WAS ADVANCED AND DEPLOYED. UPON DEVICE LOCKING, THE MANDREL MOVED INTO THE CONTROL CATHETER TIP SLOT AND PREVENTED THE LOCK LOOP FROM ACTUATING. THE PHYSICIAN UNSCREWED THE DELIVERY CATHETER LUER AND ADVANCED THE CATHETER TO REALIGN THE DEVICE. THE LOCK LOOP RELEASED, AND THE DEVICE WAS IMPLANTED. AFTER DEPLOYMENT, A SMALL PERICARDIAL EFFUSION WAS NOTED, WHICH WAS ATTRIBUTED TO THE PATIENT¿S ANATOMY AND DEVICE MANIPULATION ASSOCIATED WITH THE TIP SLOT ISSUE DESCRIBED ABOVE. APPROXIMATELY 22CC'S WAS DRAINED AND PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 25083399 ↗
• InjuryApr 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED; THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2026. AT A FOLLOW-UP APPOINTMENT ON (B)(6) 2026, A THROMBUS WAS NOTED ON THE DEVICE. THE PATIENT WAS TREATED WITH HEPARIN. THE REASON THE PATIENT WENT IN FOR AN EARLY ECHO WAS A REPORT OF ATRIAL FIBRILLATION, WHICH HAS SINCE RESOLVED WITH NO TREATMENT.

  Patient problems: Atrial Fibrillation; Thrombosis/Thrombus

  MAUDE report 24999819 ↗
• InjuryApr 21, 2026Patient-Device Incompatibility

  IT WAS REPORTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS IMPLANTED ON (B)(6)2025 TO TREAT A PATENT FORAMEN OVALE. ON (B)(6) 2026, THE PATIENT WAS DIAGNOSED WITH ATRIAL FIBRILLATION AND WAS PRESCRIBED ELIQUIS.

  Patient problems: Atrial Fibrillation

  MAUDE report 24944337 ↗
• InjuryApr 17, 2026Migration

  IT WAS REPORTED THAT A 30 MM GORE® CARDIOFORM SEPTAL OCCLUDER (GSO) WAS IMPLANTED TO CLOSE AN IATROGENIC ATRIAL SEPTAL DEFECT (IASD) DURING THE SAME PROCEDURE IN WHICH THE PATIENT RECEIVED AN EDWARDS M3 VALVE IMPLANT ON (B)(6), 2026. AT AN UNKNOWN POINT FOLLOWING THE PROCEDURE, THE PATIENT¿S CONDITION BEGAN TO DECLINE. ON (B)(6) 2026, IMAGING REVEALED THAT THE 30 MM GSO HAD EMBOLIZED INTO THE RIGHT PULMONARY ARTERY (PA). THE DEVICE WAS SUCCESSFULLY SNARED AND REMOVED FROM THE PA WITHOUT REPORTED COMPLICATIONS. A 44 MM GORE® CARDIOFORM ASD OCCLUDER (GCA) WAS SUBSEQUENTLY IMPLANTED. REVIEW OF FLUOROSCOPIC IMAGES BY THE FIELD SALES ASSOCIATE ON APRIL 6, 2026, INDICATED THAT THE ORIGINAL IASD WAS LARGE, MEASURING APPROXIMATELY 21 MM, AND POST-DEPLOYMENT IMAGES OF THE 30 MM DEVICE SHOWED RESIDUAL LEAKS AROUND THE DEVICE, SUGGESTING THE DEFECT MAY NOT HAVE BEEN FULLY CLOSED INITIALLY. FOLLOW-UP IMAGING PERFORMED (B)(6) 2026, CONFIRMED THAT THE 44 MM GCA REMAINS IN PLACE.

  Patient problems: Foreign Body Embolism

  MAUDE report 24913759 ↗
• InjuryApr 14, 2026Patient Device Interaction Problem

  IT WAS REPORTED; THE PHYSICIAN IMPLANTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER IN (B)(6) 2025. THE PATIENT HAD AN MRI CONFIRMED ACUTE INFARCT ON (B)(6) 2026. THROMBUS WAS NOTED ON THE RIGHT AND LEFT EYELETS OF THE DEVICE. THE PATIENT WAS TESTED WITH HEPARIN INFUSION THEN TRANSITIONED TO COUMADIN. BLOOD CULTURES AND NICKEL ALLERGY WERE ALL NEGATIVE.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 24876201 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE. DURING THE PROCEDURE, THE DEVICE WAS DEPLOYED TOO DEEP AND CROSSED THE SEPTUM WITHOUT THE USE OF A GUIDEWIRE. THE PATIENT SUBSEQUENTLY EXPERIENCED CHEST PAIN, AND IMAGING IDENTIFIED A LARGE PERICARDIAL EFFUSION. THE DEVICE WAS REMOVED AND A PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE FLUID. PATIENT WAS STABLE IN THE CARDIAC CARE UNIT.

  Patient problems: Pericardial Effusion

  MAUDE report 24768953 ↗
• InjuryApr 1, 2026Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE PHYSICIAN WAS IMPLANTING A GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A FLOPPY, ANEURYSMAL PATENT FORAMEN OVALE (PFO). THE PFO WAS CROSSED WITH A GUIDEWIRE, FIRST INTO THE LEFT ATRIAL APPENDAGE, THEN INTO THE LEFT UPPER PULMONARY VEIN. WHEN THE DEVICE WAS BEING DEPLOYED, IT WAS NOTED THAT THE CATHETER WAS IN A FENESTRATION, NOT THE PFO. THE CATHETER WAS REMOVED AND THE GUIDEWIRE CROSSED THROUGH THE PFO THIS TIME. THE GUIDEWIRE COULD NOT BE PARKED IN THE LEFT UPPER PULMONARY VEIN, SO IT WAS PLACED IN THE RIGHT UPPER PULMONARY VEIN. THE POOR INTRACARDIAC ECHOCARDIOGRAPHY(ICE) IMAGES, THE FLOPPY SEPTUM AND THE NOT IDEAL GUIDEWIRE PLACEMENT MADE VISUALIZING THE DEVICE VERY DIFFICULT. THE LEFT DISC WAS FIRST FORMED IN THE TUNNEL, SO IT WAS RECAPTURED AND DEPLOYED AGAIN. THIS TIME IT WAS FORMED OUTSIDE THE TUNNEL BUT STILL DID NOT LOOK RIGHT ON ICE. AT THIS POINT THE PATIENT BECAME UNRESPONSIVE FOR A SHORT TIME. THE PATIENT REGAINED CONSCIOUSNESS AND ANSWERED QUESTIONS BUT FELT LIKE THEY WERE GOING TO VOMIT. THE PATIENT THEN BECAME UNRESPONSIVE AGAIN. THE PATIENT WAS INTUBATED AND THE DEVICE AND CATHETER WERE REMOVED FROM THE PATIENT. A PERICARDIAL EFFUSION WAS NOTED

  Patient problems: Pericardial Effusion

  MAUDE report 24753505 ↗
• InjuryMar 10, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION AND WAS STARTED ON ELIQUIS AND METOPROLOL. THE CONDITION IS NOTED AS ONGOING.

  Patient problems: Atrial Fibrillation

  MAUDE report 24562236 ↗
• InjuryJan 26, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE AN ANEURYSMAL PATENT FORAMEN OVALE (PFO). THE PFO WAS CROSSED WITH A .035 GUIDEWIRE AND MPA CATHETER. USING INTRACARDIAC ECHOCARDIOGRAPHY, MULTIPLE ATTEMPTS WERE MADE TO GET THE WIRE INTO THE LEFT OR RIGHT UPPER PULMONARY VEIN. A NEW AMPLATZ WIRE WAS INSERTED INTO THE LEFT ATRIAL APPENDAGE AND THE CATHETER WAS REMOVED. THE 30MM DEVICE WAS INSERTED OVER THE WIRE ACROSS THE PFO. THE LEFT DISC WAS DEPLOYED BUT TOOK ON AN ODD SHAPE OF POSSIBLE BEING DEPLOYED IN THE TUNNEL. THE ECHO IMAGES WERE NOT SHOWING THE DEVICE WELL AS THE DEVICE WAS MOVED FORWARD. ONE MORE ATTEMPT TO FORM THE LEFT DISC WAS HAPPENING WHEN THE BLOOD PRESSURE WAS NOTED TO BE DROPPING. AN EFFUSION WAS NOTED IN THE ROOF OF THE LEFT ATRIUM, SO THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. A PERICARDIOCENTESIS WAS PERFORMED BUT DUE TO REOCCURRING BLEEDING THE PATIENT WAS TAKEN TO THE OR AND A PERICARDIAL WINDOW WAS PERFORMED TO ADDRESS THE EFFUSION. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 24177066 ↗
• InjuryJan 22, 2026Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. THE DEVICE WAS PLACED AND LOCKED WITH THE CORD RELEASED. SHORTLY AFTER, THE DEVICE EMBOLIZED TO THE DECENDING AORTA. A SNARE WAS USED TO REMOVE THE DEVICE. THE DEFECT WAS THEN BALLOON SIZED AND A LARGER 48MM GORE® CARDIOFORM ASD OCCLUDER WAS ATTEMPTED. A RESIDUAL SHUNT WAS NOTED, AND THE DEVICE WAS IMPINGING ON THE MITAL VALVE. THIS DEVICE WAS ALSO REMOVED. A NEW 48MM DEVICE WAS IMPLANTED SUCCESSFULLY IN THE PATIENT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 24146481 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A PATENT FORAMEN OVALE. NO ISSUES WERE NOTED DURING THE PROCEDURE. A LONG SL1 CATHETER WAS USED TO CROSS THE PFO AND INTRACARDIAC ECHOCARDIOGRAPHY WAS USED DURING THE PROCEDURE. THE DEVICE WAS IMPLANTED AND 45 MINUTES TO AN HOUR AFTER THE PROCEDURE, THE PATIENT WAS IN A COMA. AN AIR EMBOLISM WAS THE SUSPECTED CAUSE.

  Patient problems: Coma

  MAUDE report 24145725 ↗
• MalfunctionDec 9, 2025Activation, Positioning or Separation Problem

  CARDIOFORM DEVICE FAILED WHILE DEPLOYING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756241 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE PHYSICIAN IMPLANTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A PATENT FORAMEN OVALE ON (B)(6) 2025. THE DEVICE WAS IMPLANTED WITH NO ISSUES. ON (B)(6) 2025, THE PATIENT DEVELOPED ATRIAL FIBRILLATION AND SUPRAVENTRICULAR TACHYCARDIA. TREATMENT IS UNKNOWN AT THIS POINT. THE DEVICE REMAINS IN GOOD POSITION.

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 23742188 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A LONG TUNNEL PATENT FORAMEN OVALE (PFO). THE PFO WAS CROSSED WITH A GUIDEWIRE AND AS THE LEFT DISC WAS BEING DEPLOYED, A PERICARDIAL EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAPHY. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 23638502 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A PATENT FORAMEN OVALE (PFO). THE PFO WAS CROSSED WITH AN AMPLATZ SUPER STIFF .035 GUIDEWIRE. IT WAS UNCLEAR IF THE GUIDEWIRE WAS IN THE LEFT ATRIAL APPENDAGE OR IN THE LEFT UPPER PULMONARY VEIN. INTRACARDIAC ECHOCARDIOGRAPHY WAS ALSO USED DURING THIS CASE. THERE WERE SOME ISSUES WITH MANEUVERING THE PROBE IN THE RIGHT DIRECTION. THE CARDIOFORM DEVICE WAS ADVANCED AND DEPLOYED. AFTER REPOSITIONING, THE DEVICE WAS LOCKED AND RELEASED. THE PATIENT WAS TRANSFERRED TO RECOVERY AND AFTER ABOUT 10 MINUTES IN THE ROOM, THE PATIENT¿S BLOOD PRESSURE DROPPED. A BEDSIDE ECHO WAS PERFORMED, AND A PERICARDIAL EFFUSION WAS OBSERVED. A PERICARDIOCENTESIS WAS PERFORMED AND A DRAIN WAS PLACED. AFTER MEDICAL MANAGEMENT ALL VITALS WERE NORMALIZED, AND THE PATIENT WAS STABLE. THE PHYSICIAN WAS UNCERTAIN ON WHAT EXACTLY CAUSED THE DELAYED PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 23475769 ↗
• InjurySep 16, 2025Material Deformation; Material Protrusion/Extrusion

  ELECTIVE OUTPATIENT PFO [PATENT FORAMEN OVALE] CLOSURE COMPLICATED BY LEFT ATRIAL PERFORATION AND TAMPONADE REQUIRING EMERGENT PERICARDIOCENTESIS AND PERICARDIAL DRAIN. SUDDEN PERICARDIAL EFFUSION AFTER THE INSERTION OF THE PFO DEVICE AND DELIVERY SYSTEM (GORE CARDIOFORM SEPTAL OCCLUDER 30MM) WERE PLACED INTO THE BODY. THE PATIENT WAS EMERGENTLY TRANSCUTANEOUSLY PACED AND AN EMERGENT PERICARDIOCENTESIS WAS PERFORMED. RICU [RESPIRATORY INTENSIVE CARE UNIT] AND CT [CARDIOTHORACIC] SURGERY WERE EMERGENTLY CONTACTED FOR ASSISTANCE. THE DELIVERY SYSTEM AND OCCLUDER WERE REMOVED INTACT, OCCLUDER NOT DEPLOYED. PATIENT WAS ULTIMATELY ADMITTED TO THE ICU [INTENSIVE CARE UNIT] FOR CLOSE OBSERVATION AFTER DETERMINING WITH CARDIAC SURGERY THAT THE PATIENT DID NOT NEED TO EMERGENTLY GO TO THE OR. UPON REVIEW AFTER REMOVAL, THE ATTENDING PROCEDURALIST BELIEVES THE PFO OCCLUDER DEVICE WAS DEFECTIVE AND THOUGHT THE END WAS POSSIBLY MORE POINTED THAN USUAL, THE SILVER WIRE PROTRUDING FROM THE TIP OF THE DEVICE SHOULD NOT BE THERE AND LIKELY CAUSED THE PERFORATION. PRODUCT INFORMATION: GORE CARDIOFORM SEPTAL OCCLUDER 30MM. REF (B)(4). SERIAL NUMBER [(B)(6)]. EXPIRATION DATE 7/6/2027. MANUFACTURE DAT

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23061774 ↗
• InjurySep 4, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A PATENT FORAMEN OVALE ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT PRESENTED AT A HOSPITAL WITH CHEST PAIN AND A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED, NOTING THROMBUS ON THE RIGHT ATRIAL DISC. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS PERFORMED AT A DIFFERENT HOSPITAL (IMPLANT SITE) ON (B)(6) 2025. IMAGING DEMONSTRATED THROMBUS ON THE RIGHT ATRIAL DISC. THE PATIENT WILL BE TREATED WITH ANTICOAGULATION MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22963770 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® CARDIOFORM SEPTAL OCCLUDER INTO A LONG TUNNEL, FLOPPY PATENT FORAMEN OVALE. ABOUT 45 MINUTES AFTER THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS NOTED. THE PATIENT WAS TREATED WITH A PERICARDIOCENTESIS WHERE 600 CCS WERE DRAINED AND AUTO-TRANSFUSED BACK TO THE PATIENT. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 22959062 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN SELECTED A 30MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A 10MM X 10MM ATRIAL SEPTAL DEFECT. DURING DEVICE IMPLANT, THE PATIENT COMPLAINED OF CHEST PAIN. FOLLOWING DEVICE IMPLANT A PERICARDIAL EFFUSION WAS NOTED. PERICARDIOCENTESIS WAS PERFORMED BUT THE BLEEDING DIDN'T STOP AND THE PATIENT WAS PREPPED FOR SURGERY IN THE CATH LAB. A SURGEON SUCCESSFULLY TREATED THE EFFUSION, NOTING A TEAR IN THE WALL OF THE LEFT ATRIUM. THE DEVICE REMAINS IMPLANTED AND THE PATIENT WAS STABLE FOLLOWING SURGERY. THE PHYSICIAN NOTED THE LEFT ATRIAL DISC MAY HAVE BEEN DEPLOYED DEEPER INTO THE LEFT ATRIUM THAN NORMAL.

  Patient problems: Pericardial Effusion

  MAUDE report 22852587 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A GORE® CARDIOFORM SEPTAL OCCLUDER INTO A LONG TUNNEL PATENT FORAMEN OVALE. DURING THE PROCEDURE, THE INTRACARDIAC ECHOCARDIOGRAPHY WAS FREEZING UP. THE DEVICE WAS ADVANCED FORWARD IN THE TUNNEL. A FEW MINUTES LATER A PERICARDIAL EFFUSION WAS NOTED, AND A DRAIN WAS INSERTED. THE DEVICE WAS REMOVED, AND THE PATIENT WAS KEPT IN THE HOSPITAL UNTIL NO MORE BLOOD WAS DRAINING.

  Patient problems: Pericardial Effusion

  MAUDE report 22639849 ↗
• InjuryJul 11, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A 30 MM GORE® CARDIOFORM SEPTAL OCCLUDER HAD BEEN SELECTED TO TREAT AN ADULT PATIENT WITH A PATENT FORAMEN OVALE (PFO) EXHIBITING MULTIPLE FENESTRATIONS. A SIGNIFICANT PERICARDIAL EFFUSION WAS IDENTIFIED POST-PROCEDURE WITH THE ASSISTANCE OF THE ICE REPRESENTATIVE. APPROXIMATELY 900CC OF FLUID WAS DRAINED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. BLEEDING HAD CEASED BY THE END OF THE CASE, AND PROTAMINE WAS ADMINISTERED. THE FSA NOTED THAT DURING DEPLOYMENT, THERE WAS SOME UNCERTAINTY REGARDING THE PRECISE LOCATION WITHIN THE ATRIUM; HOWEVER, THE DEVICE WAS SUCCESSFULLY DEPLOYED. THE PATIENT WAS STABLE UPON LEAVING THE CATH LAB. IT WAS ALSO NOTED DURING THE PROCEDURE THAT DURING THE LOCKING STEP, A TIP SLOT SLIDER EVENT OCCURRED BUT WAS PROMPTLY CORRECTED WITHOUT COMPLICATION. THIS EVENT IS NOT BELIEVED TO BE RELATED TO THE PERICARDIAL EFFUSION.

  Patient problems: Pericardial Effusion

  MAUDE report 22480899 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT A 30 MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED FOR THE TREATMENT OF A PATENT FORAMEN OVALE (PFO). A POST-PROCEDURE PERICARDIAL EFFUSION WAS REPORTED, AND APPROXIMATELY 700 ML OF BLOOD WAS DRAINED. THE PATIENT WAS RETURNED TO SURGERY FROM THE RECOVERY AREA FOR THIS INTERVENTION. THE PATIENT TOLERATED THE PROCEDURE WELL, IS REPORTED TO BE DOING FINE, AND THE DEVICE REMAINS IMPLANTED. IT WAS NOTED BY THE FIELD SALES ASSOCIATE (FSA) SUPPORTING THE CASE THAT DURING THE PROCEDURE, THERE WAS SOME DIFFICULTY CROSSING THE TUNNEL, PROMPTING THE PHYSICIAN TO SWITCH TO A STRAIGHT WIRE, AFTER WHICH THE PROCEDURE APPEARED TO PROCEED SMOOTHLY.

  Patient problems: Pericardial Effusion

  MAUDE report 22480588 ↗
• InjuryJul 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 30 MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE ON (B)(6) 2025. AT THE PATIENT'S ONE MONTH FOLLOW-UP, EKG SHOWED ATRIAL FLUTTER. ASPIRIN WAS STOPPED AND APIXABAN WAS STARTED. AN OUTPATIENT REFERRAL WAS PLACED FOR CARDIOVERSION AND LEFT ATRIAL APPENDAGE COMPUTED TOMOGRAPHY ANGIOGRAPHY.

  Patient problems: Atrial Flutter

  MAUDE report 22372402 ↗