GORE CARDIOFORM Septal Occluder GSX0025ARecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00733132631025), received between Nov 6, 2018 and Sep 2, 2026 — classified as 1 death, 84 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (17 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 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Difficult or Delayed Positioning; Migration

  Patient problems: Foreign Body Embolism

  MAUDE report 50571013 ↗
• InjuryApr 30, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THAT A 25 MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT A PATENT FOREMAN OVALE (PFO). REPORTEDLY, THE PFO WAS CROSSED WITHOUT ISSUE AND WAS INITIALLY POSITIONED APPROPRIATELY; THE DEFECT WAS NOT BALLOON SIZED. DURING DEPLOYMENT OF THE LEFT ATRIAL DISC, THE DISC APPEARED TO DEPLOY WITHIN THE PFO TUNNEL. THE PHYSICIAN RETRACTED THE DISC INTO THE DELIVERY SYSTEM, ADVANCED THE SYSTEM, AND ATTEMPTED REDEPLOYMENT, BUT THE DISC APPEARED "SQUISHED". THE ENTIRE DELIVERY SYSTEM WAS REMOVED, AND A NEW DEVICE OF THE SAME SIZE WAS SUCCESSFULLY DEPLOYED WITHOUT ISSUE. FOLLOWING DEVICE IMPLANT, THE PATIENT EXPERIENCED A REACTION TO A PROTAMINE TEST DOSE AND HAD ALSO DEVELOPED A PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS, WHICH WAS ASSESSED BY THE PHYSICIAN AS BEING RELATED TO THE FIRST DEVICE ATTEMPTED. THE PATIENT ULTIMATELY TOLERATED THE PROCEDURE AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pericardial Effusion

  MAUDE report 25047508 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT HAD PAROXYSMAL ATRIAL FIBRILLATION, WHICH WAS TREATED WITH ELIQUIS.

  Patient problems: Atrial Fibrillation

  MAUDE report 24867120 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT HAD ATRIAL FIBRILLATION, WHICH WAS TREATED WITH METOPROLOL TARTRATE AND A 14 DAY HEART RYTHUM MONITOR WAS PLACED.

  Patient problems: Atrial Fibrillation

  MAUDE report 24778914 ↗
• InjuryMar 10, 2026Patient-Device Incompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2020. ON (B)(6) 2021 THE PATIENT WAS NOTED TO HAVE PAROXYSMAL ATRIAL FIBRILLATION. THE PATIENT WAS SUBSEQUENTLY TREATED WITH BETA BLOCKERS AND METOPROLOL.

  Patient problems: Atrial Fibrillation

  MAUDE report 24563323 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THE PHYSICIAN SELECTED A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A PATENT FORAMEN OVALE (PFO). DURING DEPLOYMENT, IT WAS NOTED THE DISTAL TIP OF THE DELIVERY CATHETER SPECIFICALLY AT THE WIRE PORT EXIT BROKE. THE DEVICE WAS ADVANCED FROM THE INFERIOR VENA CAVA TO THE RIGHT ATRIUM BUT WOULD NOT ADVANCE ACROSS THE PFO INTO THE LEFT ATRIUM. PHYSICIAN USED FORCEFUL BACK AND FORTH MOTION AT THE ATRIAL SEPTUM IN ATTEMPTS TO GET THE DELIVERY SYSTEM TO CROSS THE LEFT ATRIUM. WHEN THE DEVICE WOULD NOT CROSS, IT WAS REMOVED. ONCE REMOVED, IT WAS NOTED THE DISTAL TIP OF THE DELIVERY CATHETER WAS STILL IN THE BODY. FLUOROSCOPY WAS USED TO LOCATE THE TIP, ON THE WIRE, AT THE FEMORAL SHEATH. A 4.0X40 BALLOON WAS USED TO SECURE THE BROKEN TIP. FRAGMENTS OF DISTAL TIPS WERE REMOVED FROM THE BODY AND PATIENT WAS SCHEDULED FOR SURGERY TO COMPLETE DEFECT CLOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092916 ↗
• InjuryDec 23, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THE PHYSICIAN SELECTED A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE. THE OCCLUDER WAS PREPPED AND ABOUT TO BE ADVANCED INTO THE PATIENT WHEN THE GUIDEWIRE POSITION WAS LOST. THE PHYSICIAN REPOSITIONED THE WIRE, THEN THE DEVICE WAS ADVANCED. INTRACARDIAC ECHOCARDIOGRAPHY SHOWED THE LEFT DISC WAS STILL IN THE TUNNEL WHEN DEPLOYMENT WAS ATTEMPTED. THE OCCLUDER WAS RELOADED AND ANOTHER DEPLOYMENT ATTEMPT WAS MADE. AGAIN, IT APPEARED THAT THE LEFT DISC WAS DEPLOYING IN THE TUNNEL. THE DEVICE WAS RELOADED AND THE THIRD DEPLOYMENT ATTEMPT WAS SUCCESSFUL. THE DEVICE WAS LOCKED AND RELEASED WITHOUT ISSUE. THE PATIENT COMPLAINED OF CHEST/BACK PAIN AND ECHOCARDIOGRAPHY SHOWED A LARGE PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS SENT TO SURGERY. THE PHYSICIAN COMMUNICATED THAT THE PATIENT HAD A STERNOTOMY AND PATCHES WERE USED TO TREAT TWO POSTERIOR PERFORATIONS. THE PHYSICIAN NOTED THE DEVICE MAY HAVE BEEN TOO DEEP INTO THE ATRIUM WHEN UNSHEATHING OR DEPLOYING THE OCCLUDER.

  Patient problems: Pericardial Effusion

  MAUDE report 23878168 ↗
• InjuryDec 19, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTED A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2018, TO CLOSE AN ATRIAL SEPTAL DEFECT. A SHUNT WAS NOTED AT THE ONE YEAR FOLLOW-UP. ON (B)(6) 2025, AN ADDITIONAL TRANSCATHETER PROCEDURE WAS PERFORMED TO PLACE A SECOND 25MM GORE® CARDIOFORM SEPTAL OCCLUDER. THE PHYSICIAN WAS ABLE TO CROSS THE CATHETER AROUND THE EDGE OF THE DEVICE THROUGH THE SHUNT AND IMPLANT THE DEVICE TO CLOSE THE SHUNT SUCCESSFULLY. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Cardiac Septal Defect Residual Shunt

  MAUDE report 23851927 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION OBTAINED FROM THE MEDRIO CLINICAL STUDY DATABASE INDICATES THAT A GORE® CARDIOFORM SEPTAL OCCLUDER WAS IMPLANTED ON (B)(6), 2025. ON (B)(6) 2025, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION. THE PATIENT WAS TREATED WITH PLAVIX WHICH WAS SUBSEQUENTLY CHANGED TO ELIQUIS AND METOPROLOL.

  Patient problems: Atrial Fibrillation

  MAUDE report 23829252 ↗
• MalfunctionNov 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A 25 MM GORE® CARDIOFORM SEPTAL OCCLUDER (GSO) WAS SELECTED FOR THE TREATMENT OF A PATENT FORAMEN OVALE (PFO). DURING ADVANCEMENT THROUGH THE DELIVERY CATHETER, THE TIP OF THE CATHETER SHEARED OFF. NO UNUSUAL FRICTION OR RESISTANCE WAS REPORTED DURING DEVICE ADVANCEMENT, AND THERE WAS NO EVIDENCE OF KINKING OR BENDING OF THE DELIVERY CATHETER BEFORE OR DURING THE CASE. THE DELIVERY CATHETER WAS INSPECTED PRIOR TO USE, AND NO ABNORMALITIES WERE NOTED. THE BROKEN CATHETER TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT USING A BALLOON AND SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 25 MM GSO DEVICE, AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. THE PHYSICIAN HAS NOT IDENTIFIED A DEFINITIVE CAUSE FOR THE CATHETER TIP SHEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633390 ↗
• InjuryNov 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THE PHYSICIAN SELECTED A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE. DURING DEPLOYMENT THE OCCLUDER FORMED IMPROPERLY AND IT APPEARED TO BE DEPLOYED IN THE TUNNEL. THE PHYSICIAN RELOADED THE OCCLUDER, RECROSSED THE SEPTUM, THEN DEPLOYED AND LOCKED THE DEVICE. UPON FURTHER ASSESSMENT, IT WAS NOTED THAT THE OCCLUDER WAS TOO SMALL AS IT DIDN'T CAPTURE THE WHOLE SEPTUM. THE OCCLUDER WAS REMOVED WITHOUT ISSUE; HOWEVER, FOLLOWING REMOVAL A PERICARDIAL EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAPHY. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABLE. THE PROCEDURE WAS CONCLUDED WITHOUT DEFECT CLOSURE.

  Patient problems: Pericardial Effusion

  MAUDE report 23535295 ↗
• InjurySep 16, 2025Prophylactic removal due to corrective action; Prophylactic removal due to corrective action

  IT WAS REPORTED TO GORE THAT DURING A LAB WORKSHOP, THE PHYSICIAN SHARED A PRIOR CLINICAL EXPERIENCE INVOLVING A PATIENT WITH A SUSPECTED NICKEL ALLERGY. THE PATIENT UNDERWENT A SUCCESSFUL AND UNEVENTFUL PFO CLOSURE PROCEDURE USING A GORE® CARDIOFORM SEPTAL OCCLUDER (GSO) ON (B)(6) 2019, TO TREAT HYPOXEMIA WITH ACTIVITY. APPROXIMATELY TWO WEEKS POST-IMPLANT, THE PATIENT PRESENTED WITH CHEST PAIN AND SHORTNESS OF BREATH. ON (B)(6) 2019, SHE WAS ADMITTED TO THE EMERGENCY ROOM WITH A PERICARDIAL EFFUSION AND WAS TREATED WITH PREDNISONE. SHE RETURNED ON (B)(6) 2019, WITH RECURRENT SHORTNESS OF BREATH, AND THE PHYSICIAN NOTED THAT THE PERICARDIAL EFFUSION WAS NOT LARGE ENOUGH TO CAUSE TAMPONADE. SYMPTOMS AGAIN IMPROVED WITH PREDNISONE. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED AGAIN WITH A PERICARDIAL EFFUSION AND WAS REFERRED TO THE ALLERGY DEPARTMENT, WHERE NICKEL ALLERGY WAS CONFIRMED VIA SKIN TESTING. BASED ON THE SUSPECTED ALLERGIC REACTION, THE DECISION WAS MADE TO EXPLANT THE DEVICE. ON (B)(6) 2019, THE PATIENT UNDERWENT ROBOTIC-ASSISTED SURGICAL REMOVAL OF THE GSO AND A LINQ HEART FAILURE MONITOR. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. FOLLOWING DEVICE REMOVAL, TH

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23069609 ↗
• InjuryAug 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS IMPLANTED TO TREAT A PATENT FORAMEN OVALE ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION AND WAS TREATED WITH ELIQUIS. THE CONDITION IS NOTED AS ONGOING.

  Patient problems: Atrial Fibrillation

  MAUDE report 22832869 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT A GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT AN ADULT PATIENT WITH A PATENT FORAMEN OVALE (PFO). THE DEVICE WAS SUCCESSFULLY IMPLANTED. HOWEVER, WHILE PREPARING TO TRANSFER THE PATIENT TO RECOVERY, THE PATIENT EXPERIENCED A SUDDEN DROP IN BLOOD PRESSURE. THE GROIN ACCESS SITE WAS ASSESSED AND FOUND TO BE INTACT. FURTHER EVALUATION REVEALED FLUID ACCUMULATION IN THE PERICARDIUM, SUGGESTING A POSSIBLE PERFORATION. APPROXIMATELY 800 ML TO 1 LITER OF PERICARDIAL FLUID WAS DRAINED IN THE CATH LAB, STABILIZING THE PATIENT FOR SAFE TRANSPORT. THE PATIENT REQUIRED TRANSFUSION AND WAS TAKEN TO SURGERY, WHERE THE DEFECT WAS PATCHED. THE OCCLUDER DEVICE REMAINS IMPLANTED, AND THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 22744795 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED; THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6)2025. ON (B)(6) 2025, THE PATIENT WAS NOTED TO HAVE ATRIAL FIBRILLATION. THE PATIENT WAS STARTED ON ANTICOAGULATION MEDICATION. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 22470616 ↗
• InjuryJun 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THE PHYSICIAN SELECTED A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A LONG, NON-COMPLIANT PATENT FORAMEN OVALE. THE TUNNEL WAS BALLOONED AT THE BEGINNING OF THE PROCEDURE. THE PHYSICIAN EXPERIENCED DIFFICULTY CROSSING THE DEFECT WITH A GLIDEWIRE. THE GLIDEWIRE WAS THEN SWITCHED TO AN AMPLATZ GUIDEWIRE, AND THE DEFECT WAS CROSSED. UPON OCCLUDER DEPLOYMENT, IT APPEARED THE RIGHT DISC WAS DEPLOYING IN THE TUNNEL DUE TO THE LONG TUNNEL LENGTH. THE OCCLUDER WAS REMOVED AND THE PHYSICIAN BALLOONED THE TUNNEL A SECOND TIME. THE SAME 25MM OCCLUDER WAS ATTEMPTED AGAIN, BUT THE TUNNEL WAS TOO LONG TO ACCOMMODATE THE DEVICE AND IT WAS REMOVED. AT THIS POINT THE PATIENT FELT ILL AND THEN THEIR BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS NOTED AND THE PATIENT WAS INTUBATED AND DRAINED (APPROXIMATELY 550 ML). THE PATIENT WAS STABLE WHEN LEAVING THE ROOM AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WITH A GRAVITY DRAIN.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22197716 ↗
• MalfunctionMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 25 MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE A PATENT FORAMEN OVALE. THE PHYSICIAN FELT FRICTION WHILE ADVANCING THE DELIVERY CATHETER OVER THE GUIDEWIRE THROUGH THE 11 FR PINNACLE INTRODUCER SHEATH. IT WAS DECIDED TO REMOVE THE DELIVERY CATHETER. UPON INSPECTION OF THE REMOVED CATHETER, IT WAS NOTED THAT THE RADIOPAQUE MARKER AND GUIDEWIRE PORT WERE MISSING FROM THE TIP OF THE DELIVERY CATHETER. IT WAS STILL ON THE GUIDEWIRE JUST OUTSIDE THE TIP OF THE INTRODUCER SHEATH. A SNARE WAS USED TO REMOVE THE TIP OF THE CATHETER WITHOUT INCIDENT. A NEW 25 MM DEVICE WAS IMPLANTED WITH NO ISSUES. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. IT WAS ALSO STATED THAT THE INTRODUCER SHEATH WAS DAMAGED AND CRUNCHED UP AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090200 ↗
• InjuryApr 23, 2025Migration; Migration

  ON (B)(6) 2025, A PHYSICIAN IMPLANTED A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FOREMAN OVALE AND AN ATRIAL SEPTAL DEFECT. THE FOLLOWING DAY, THE DEVICE EMBOLIZED TO THE ABDOMINAL AORTA. THE DEVICE WAS SUCCESSFULLY REMOVED WITH A SNARE AND A 37MM GORE® CARDIOFORM ASD OCCLUDER WAS SUBSEQUENTLY IMPLANTED TO ENSURE PROPER CLOSURE. THE REMOVAL AND IMPLANT PROCEDURES WERE COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Foreign Body Embolism

  MAUDE report 21892077 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT A 25 MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS SELECTED TO TREAT A PATENT FORAMEN OVALE (PFO). THE DEVICE WAS SUCCESSFULLY IMPLANTED. HOWEVER, LATER THAT DAY, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION, NECESSITATING THE DRAINAGE OF 500 CC OF BLOOD. THE PATIENT IS CURRENTLY STABLE, AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pericardial Effusion

  MAUDE report 21874712 ↗
• InjuryOct 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE ON (B)(6) 2024. ON 11 JUNE 2024, AN EKG DETECTED PREMATURE ATRIAL CONTRACTIONS. CURRENTLY, TREATMENT IS UNKNOWN.

  Patient problems: Arrhythmia

  MAUDE report 20570970 ↗
• InjurySep 20, 2024Adverse 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 25MM GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2024, TO CLOSE AN ATRIAL SEPTAL DEFECT. THE NEXT DAY ON THE EKG, THE PATIENT WAS IN COMPLETE HEART BLOCK, WITH AV DISSOCIATION. THE PATIENT WAS STARTED ON STEROIDS AND A HEART MONITOR AND WAS DISCHARGED WITH PARTIAL RESOLUTION THE NEXT DAY. THE DEVICE REMAINS IMPLANTED, IN GOOD POSITION.

  Patient problems: Heart Block

  MAUDE report 20267419 ↗
• InjuryJul 22, 2024Adverse 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 25MM GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2024. THE DEVICE WAS IMPLANTED WITH NO ISSUES. ON (B)(6) 2024, THE PATIENT RETURNED TO THE HOSPITAL WITH A LOW-GRADE FEVER AND WAS EXPERIENCING ATRIAL FIBRILLATION. THE PATIENT WAS STARTED ON AMIODARONE FOR THE ARRHYTHMIA. THE DEVICE REMAINS IN GOOD POSITION AND THE FEVER AND AFIB HAVE RESOLVED.

  Patient problems: Atrial Fibrillation

  MAUDE report 19794399 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER WAS IMPLANTED ON (B)(6) 2024 TO TREAT A PATENT FORAMEN OVALE. IT WAS REPORTED THAT POST PROCEDURE ON THE SAME DAY, THE PATIENT DEVELOPED ATRIAL FIBRILLATION. IT WAS REPORTED THE ATRIAL FIBRILLATION WAS CONTROLLED BY MEDICATION.

  Patient problems: Atrial Fibrillation

  MAUDE report 19623297 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS OBTAINED THROUGH THE CLINICAL STUDY GSO 18-01: IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE® CARDIOFORM SEPTAL OCCLUDER ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT PRESENTED WITH ATRIAL FLUTTER AND WAS TREATED WITH A CHANGE TO ANTICOAGULATION, AN ADDITIONAL MEDICATION WAS STARTED, AND LINQ WAS IMPLANTED. IT WAS REPORTED THIS EVENT IS ONGOING.

  Patient problems: Atrial Flutter

  MAUDE report 18993608 ↗
• InjuryMar 28, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT A PATENT FORAMEN OVALE ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION. THE PATIENT WAS TREATED WITH XARELTO AND THE ATRIAL FIBRILLATION RESOLVED THE SAME DAY. ON (B)(6) 2022, THE PATIENT PRESENTED WITH ATRIAL FIBRILLATION. THE ATRIAL FIBRILLATION RESOLVED (B)(6) 2022 WITH TREATMENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 18993192 ↗