GORE CARDIOFORM ASD Occluder ASD44ARecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00733132636518), received between Oct 3, 2019 and Sep 16, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (4 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Positioning Problem; Migration

  Patient problems: Foreign Body Embolism

  MAUDE report 50793720 ↗
• MalfunctionSep 3, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589761 ↗
• InjuryMay 6, 2026Difficult or Delayed Positioning

  IT WAS REPORTED; THE PHYSICIAN WAS IMPLANTING A 48MM GORE® CARDIOFORM ASD OCCLUDER, TO CLOSE AN ATRIAL SEPTAL DEFECT. THE ASD HAD A BALD AORTIC RIM. THE DEFECT BALLOON SIZED TO 23-24 MM. THE PHYSICIAN CHOSE TO TRY THE 48MM DEVICE FIRST BECAUSE OF THE BALD RIM. THE DEVICE WAS ATTEMPTED WITH THE USE OF A MULLINS SHEATH. AFTER MULTIPLE ATTEMPTS WITH THE DEVICE SLIPPING OFF THE AORTIC RIM, THE PHYSICIAN TRIED TO USE A 44 MM GORE® CARDIOFORM ASD OCCLUDER. THE 44MM DEVICE ALSO PROLAPSED THROUGH THE BALD AORTIC RIM. THE NEXT STEP WAS TO CURVE THE CATHETER OUTSIDE THE BODY AND TRY AGAIN. BEFORE THE DEVICE WAS INSERTED AGAIN, A PERICARDIAL EFFUSION WAS NOTED, AND THE PATIENT WAS TREATED WITH A PERICARDIOCENTESIS. THE EFFUSION APPEARED TO COME FROM THE FREE WALL OF THE LEFT ATRIUM. AN AMPLATZER DEVICE WAS IMPLANTED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 25098593 ↗
• InjuryJan 26, 2026Positioning Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 37MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT A THICK SECUNDUM ATRIAL SEPTAL DEFECT (ASD) STATIC SIZED 18.2MM. THE DEFECT WAS NOT BALLOON SIZED. A ROSEN J-TIPPED GUIDEWIRE AND 14 FR SHEATH WERE USED TO CROSS THE DEFECT. THE OCCLUDER WAS THEN ADVANCED AND MULTIPLE DEPLOYMENT ATTEMPTS WERE MADE BUT THE OCCLUDER DID NOT SUCCESSFULLY CLOSE THE DEFECT AND A SHUNT REMAINED. THE 37MM DEVICE WAS REMOVED AND THE PHYSICIAN SELECTED A 44MM GORE® CARDIOFORM ASD OCCLUDER. FOLLOWING MULTIPLE ATTEMPTS OF DEPLOYING AND REPOSITIONING, A PERICARDIAL EFFUSION WAS NOTED (APPROXIMATELY 2 HOURS INTO THE PROCEDURE) AND THE DEVICE WAS REMOVED. A PERICARDIOCENTESIS WAS PERFORMED. ONE LITER OF FLUID WAS TAPPED, AND PATIENT WAS WATCHED FOR 20 MINUTES BEFORE BEING SENT TO SURGERY. THE PATIENT WAS STABLE BEFORE BEING TRANSFERRED TO THE OR. THE PHYSICIAN WAS UNSURE OF WHAT CAUSED THE PERICARDIAL EFFUSION BUT DID NOT THINK IT WAS OCCLUDER RELATED.

  Patient problems: Pericardial Effusion

  MAUDE report 24182790 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44 MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT MEASURING APPROXIMATELY 25 MM, WITH A DEFICIENT AORTIC RIM AND A SMALL POSTERIOR RIM. THE PHYSICIAN ATTEMPTED MULTIPLE DEPLOYMENTS WITH THE SAME DEVICE; HOWEVER, AFTER SEVERAL LOADING AND RELOADING CYCLES, THE DEVICE BECAME INCREASINGLY DIFFICULT TO LOAD. THE DECISION WAS MADE TO DISCONTINUE USE OF THAT DEVICE AND PROCEED WITH A NEW 44 MM OCCLUDER. THE REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED WITH ASSISTANCE FROM THE SENIOR PARTNER. FOLLOWING IMPLANTATION, THE PHYSICIAN REPORTED THAT THROMBUS WAS OBSERVED ON THE DEVICE DURING A FOLLOW-UP CALL ON FRIDAY EVENING. THE PATIENT SUBSEQUENTLY DEVELOPED A MILD FEVER AROUND TUESDAY EVENING AND WAS EVALUATED AT AN ADULT EMERGENCY DEPARTMENT BEFORE BEING TRANSFERRED TO A CHILDREN¿S HOSPITAL. AN ECHOCARDIOGRAM REVEALED THROMBUS/VEGETATION, AND ANTIBIOTICS WERE INITIATED. THE PATIENT WAS ADMITTED TO THE ICU FOR MONITORING AND CONTINUED ANTIBIOTIC THERAPY. BLOOD CULTURES SHOWED NO GROWTH, AND A REPEAT ECHOCARDIOGRAM INDICATED RESOLUTION OF THE THROMBUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 23830298 ↗
• InjuryNov 6, 2025Difficult or Delayed Positioning; Material Split, Cut or Torn; Difficult or Delayed Positioning; Material Split, Cut or Torn

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 44MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT WITH A DEFICIENT AORTIC RIM. THE DEVICE WAS LOCKED BUT IT PARTIALLY SLIPPED THROUGH THE DEFECT. WHILE REMOVING THE DEVICE WITH THE RETRIEVAL CORD, THE CORD BROKE. A LITTLE MORE THAN HALF THE DEVICE WAS PULLED INTO THE DELIVERY CATHETER. THE DEVICE WAS PULLED DOWN TO THE GROIN, WHERE A SURGICAL CUT DOWN WAS PERFORMED TO REMOVE THE DEVICE AND CATHETER. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23488616 ↗
• InjuryOct 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THIS INFORMATION WAS RECEIVED THROUGH LITERATURE ARTICLE "RECURRENT RIGHT ATRIAL THROMBUS AFTER PERCUTANEOUS ASD CLOSURE" AVAILABLE ONLINE 22 OCTOBER 2025, IN JACC CASE REPORTS. IT WAS REPORTED THE PHYSICIAN IMPLANTED A 44MM GORE® CARDIOFORM SEPTAL OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 19.5 X 18.0 MM. THE PATIENT WAS PRESCRIBED ASPIRIN 325 MG DAILY FOR 6 MONTHS. WITHIN 48 HOURS, THE PATIENT DEVELOPED INTERMITTENT FEVER, BUT INFECTIOUS WORK-UP WAS NEGATIVE, AND INITIAL TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) WAS UNREMARKABLE. THREE MONTHS POST PROCEDURE, A ROUTINE TTE REVEALED A MOBILE MASS ATTACHED TO THE RIGHT ATRIAL DISC. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED THE FINDINGS. BLOOD CULTURES REMAINED NEGATIVE AND THE MASS WAS DEEMED LIKELY THROMBOTIC IN NATURE. THE PATIENT UNDERWENT PERCUTANEOUS THROMBECTOMY WITH PATHOLOGY CONFIRMING A THROMBUS. A SMALL RESIDUAL MASS PERSISTED ON FOLLOW-UP TTE, ALONG WITH A SMALL LEFT-TO-RIGHT SHUNT. THE PATIENT WAS DISCHARGED ON APIXABAN 5 MG TWICE DAILY. ONE MONTH LATER, TTE DEMONSTRATED RECURRENT THROMBUS, CONFIRMED WITH TEE. GIVEN THE RECURRENCE DESPITE THERAPEUTIC ANTICOAGULATION, THE PATIENT UNDERWENT SURGICAL DEVIC

  Patient problems: Fever; Thrombosis/Thrombus

  MAUDE report 23404996 ↗
• InjuryDec 12, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 44MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT A SEPTAL DEFECT ON (B)(6) 2024. THE PHYSICIAN NOTIFIED GORE THAT AN EXPLANT WILL BE SCHEDULED DUE TO NICKEL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20913170 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 44MM GORE® CARDIOFORM ASD OCCLUDER USING A GUIDEWIRE. THE DEVICE WAS REPOSITIONED SEVERAL TIMES TO GET GOOD APPOSITION OF THE SEPTUM. THE DEVICE WAS PLACED AND LOCKED. RIGHT AFTER THE DELIVERY SYSTEM WAS REMOVED, A PERICARDIAL EFFUSION WAS NOTED, AND THE PATIENT WAS TREATED WITH A PERICARDIOCENTESIS AND PROTAMINE. THE DEVICE REMAINS IMPLANTED, AND THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 18730873 ↗
• InjuryOct 23, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THE PHYSICIAN SELECTED A 44MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT, MEASURED TO 18MM X 26MM BY 3D. THE DEFECT WAS NOT BALLOON SIZED DUE TO THE PHYSICIAN'S CONCERN OF TEARING SEPTAL TISSUE. INTRACARDIAC ECHOCARDIOGRAPHY WAS USED DURING THE PROCEDURE. THE FIRST AND SECOND DEPLOYMENT ATTEMPTS WERE NOT SUCCESSFUL IN CAPTURING THE RETRO AORTIC RIM, AS THE OCCLUDER PROLAPSED. THE DEVICE WAS REMOVED AND THE PHYSICIAN MANUALLY FORMED A LARGER BEND ON THE DISTAL END OF THE DELIVERY SYSTEM. THE DEVICE WAS THEN REINTRODUCED WITH A J GUIDEWIRE. UPON DEPLOYING THE RIGHT ATRIAL DISC, A PERICARDIAL EFFUSION WAS NOTED. 30MG/ML OF PROTAMINE WAS INITIATED. THE DEVICE WAS LOCKED AND ASSESSED FOR ADEQUATE COVERAGE AND THE RETRIEVAL CORD WAS REMOVED. THE PERICARDIAL EFFUSION WAS DRAINED. AN ADDITIONAL 20MG/ML OF PROTAMINE WAS ADMINISTERED. 1.5 L OF BLOOD WAS DRAINED. 30 ADDITIONAL UNITS OF PROTAMINE WAS GIVEN. THE DEVICE APPEARED STABLE WITH NO COLOR NOTED AROUND OCCLUDER. THE PATIENT WAS STABLE AND SENT TO CICU FOR MONITORING. BLOOD WAS TO BE GIVEN ON THE FLOOR.

  Patient problems: Pericardial Effusion

  MAUDE report 17986413 ↗
• InjuryApr 27, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 44MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE A MULTIFENESTRATED ATRIAL SEPTAL DEFECT. THE DEFECT BALLOON SIZED TO 18.5 MM. THE DEVICE WAS IMPLANTED WITH A SMALL RESIDUAL SHUNT STILL PRESENT. THE NEXT DAY THE POSTERIOR SHUNT HAD INCREASED. THE PHYSICIAN HAS ELECTED TO HAVE THE DEVICE REMOVED AND THE DEFECT CLOSED SURGICALLY.

  Patient problems: Unspecified Heart Problem

  MAUDE report 16824961 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE PHYSICIAN IMPLANTED A 44MM GORE® CARDIOFORM ASD OCCLUDER ON (B)(6) 2023, TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). THE DEVICE WAS IMPLANTED WITH NO ISSUES. ON (B)(6) 2023 THE PATIENT REPORTED TO THE HOSPITAL WITH SEVERE DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND SEPTIC SHOCK. SYMPTOM ONSET BEGAN APPROXIMATELY 48 HOURS POST IMPLANT. THE PATIENT HAD BEEN ON PLAVIX AND ASPIRIN. NO HISTORY OF ANTICOAGULATION PROBLEMS OR CLOTTING DISORDERS. THE OCCLUDER WAS REMOVED IN A TRANSCATHETER PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. A SAMPLE OF THE SEPTAL TISSUE SHOWED NO INFECTION. THE PATIENT IS SUFFERING WITH HEMOLYTIC UREMIC SYNDROME (HUS).

  Patient problems: Disseminated Intravascular Coagulation (DIC); Septic Shock

  MAUDE report 16403626 ↗
• InjuryDec 28, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THE PHYSICIAN SELECTED A 44MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 23MM. AFTER MULTIPLE MULTIPLE DEPLOYMENT ATTEMPTS, THE DEVICE COULD NOT BE SEATED ON THE SEPTUM. A PERICARDIAL EFFUSION WAS NOTED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY AND THE DEVICE WAS REMOVED FROM THE PATIENT, PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT WAS REFERRED FOR SURGICAL CLOSURE OF THE DEFECT.

  Patient problems: Pericardial Effusion

  MAUDE report 16060157 ↗
• InjuryJul 18, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE FOLLOWING ARTICLE WAS RECEIVED BY GORE: ¿PERCUTANEOUS MANAGEMENT OF LATE OCCLUDER DISLODGEMENT: A CASE REPORT¿. PUBLISHED ONLINE - INTERNATIONAL JOURNAL OF CARDIOLOGY CONGENITAL HEART DISEASE 8 (2022) 100369. THE ARTICLE PRESENTS THE CASE OF A 65 FEMALE WITH A 2.5 CM ASD, LEFT ATRIAL HYPERTENSION, DEFICIENT RETROAORTIC RIM, MOBILE SEPTUM PRIMUM AND HYPERTROPHIED SEPTUM SECUNDUM. SHE UNDERWENT UNCOMPLICATED CLOSURE WITH A 44-MM GORE® CARDIOFORM ASD OCCLUDER (GCA). HOWEVER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM FIVE WEEKS POST PROCEDURE AND WAS FOUND TO BE IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AT A RATE OF 158 BPM. FURTHER WORKUP SHOWED A DISLODGED GCA DEVICE DESPITE APPROPRIATE DEVICE PLACEMENT AND SIZE SELECTION BASED ON THE PUBLISHED INSTRUCTIONS FOR USE. WE ELECTED TO NOT REMOVE THE 44-MM GCA GIVEN THAT IT HAD BECOME ADHERENT TO THE SEPTUM PRIMUM BUT INSTEAD USED THE STIFFER AMPLATZER SEPTAL OCCLUDER TO STABILIZE THE GCA AND OCCLUDE THE RESIDUAL DEFECT.

  Patient problems: Atrial Fibrillation

  MAUDE report 15042426 ↗
• InjuryNov 15, 2021Fracture; Device Slipped; Fracture; Device Slipped

  IT WAS REPORTED THE PHYSICIAN SUCCESSFULLY IMPLANTED A 44MM GORE® CARDIOFORM ASD OCCLUDER ON (B)(6) 2019 TO TREAT AN ATRIAL SEPTAL DEFECT MEASURED TO 20 X 23MM. THE PATIENT WAS LOST TO FOLLOW-UP; HOWEVER, ON AN UNKNOWN DATE IN 2021, THE PATIENT EXPERIENCED A STROKE. IMAGING CONFIRMED A DEVICE-RELATED SHUNT AND IT WAS SUSPECTED THE DEVICE HAD SLIPPED ON THE SEPTUM. THE PATIENT WAS SENT TO ANOTHER HOSPITAL WHERE A SURGEON EXPLANTED THE OCCLUDER AND CLOSED THE ATRIAL SEPTAL DEFECT WITH A PATCH ON (B)(6) 2021.

  Patient problems: Ischemia Stroke

  MAUDE report 12810736 ↗
• InjuryJul 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PHYSICIAN SELECTED A 44MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 28MM IN A PATIENT WITH NO SUPERIOR RIM. THE DEVICE APPEARED STABLE FOLLOWING DEPLOYMENT AND WAS IMPLANTED WITHOUT ISSUE. THE FOLLOWING MORNING, IMAGING SHOWED THE DEVICE HAD EMBOLIZED TO THE PULMONARY ARTERY. THE OCCLUDER WAS RETRIEVED WITH A SNARE. THE PATIENT WAS DOING WELL FOLLOWING DEVICE REMOVAL AND THE DEFECT WILL LIKELY BE SURGICALLY CLOSED AT A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12227321 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE A 44MM GORE® CARDIOFORM ASD OCCLUDER WAS SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT STOP FLOW BALLOON SIZED TO 25MM. THE DEVICE WAS DEPLOYED IN THE DEFECT. IMMEDIATELY AFTER THE RIGHT DISC WAS DEPLOYED THE PATIENT EXPERIENCED COMPLETE HEART BLOCK. THE DEVICE WAS RELOADED INTO THE CATHETER AND PATIENT WAS MEDICALLY MANAGED UNTIL RHYTHM WENT BACK INTO SINUS RHYTHM. THE PATIENT REMAINS IN SINUS RHYTHM AND WILL BE TREATED SURGICALLY.

  Patient problems: Heart Block

  MAUDE report 12127869 ↗
• InjuryApr 30, 2021Migration; Migration

  IT WAS REPORTED THE PHYSICIAN SELECTED A 44MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 22MM WITH A DEFICIENT RETRO-AORTIC RIM. THE DEVICE WAS DEPLOYED, LOCKED, AND RELEASED WITHOUT ISSUE. DURING DEVICE ASSESSMENT, THE OCCLUDER EMBOLIZED INTO THE RIGHT ATRIUM. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE DEVICE WITH A SNARE; HOWEVER, THE RIGHT ATRIAL EYELET WAS STUCK ON THE TRICUSPID VALVE, AND THE PATIENT WAS SENT TO SURGERY FOR DEFECT CLOSURE AND DEVICE REMOVAL. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11754071 ↗
• InjuryJan 29, 2021Adverse 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 SELECTED TO TREAT AN ATRIAL SEPTAL DEFECT ON (B)(6) 2021. UPON LOCKING, THE DEVICE PROLAPSED AND WAS REMOVED USING THE RETRIEVAL CORD. A 44MM GORE® CARDIOFORM ASD OCCLUDER WAS THEN SELECTED AND SUCCESSFULLY IMPLANTED. IT WAS REPORTED THE PATIENT PRESENTED ON (B)(6) 2021 IN FIRST DEGREE HEART BLOCK. THE PATIENT IS BEING TREATED WITH STEROIDS AND THE DEVICE REMAINS IMPLANTED. THE PHYSICIAN REPORTED ON (B)(6) 2021 THAT THE FIRST DEGREE HEART BLOCK HAS COMPLETELY RESOLVED WITH MEDICAL MANAGEMENT. THE PATIENT WAS DISCHARGED WITH A HOLTER MONITOR AND IS DOING WELL.

  Patient problems: Arrhythmia

  MAUDE report 11250843 ↗
• InjuryJan 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO GORE A 44MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED ON (B)(6) 2020 TO TREAT AN ATRIAL SEPTAL DEFECT WITH A DEFICIENT INFERIOR RIM. LATER THAT EVENING THE PATIENT COMPLAINED OF CHEST PAIN. CHEST X-RAY AND ECHOCARDIOGRAM CONFIRMED THE DEVICE HAD EMBOLIZED TO THE LEFT PULMONARY ARTERY AND WAS BLOCKING FLOW. THE PATIENT WAS TAKEN BACK TO THE CATHERIZATION LAB TO ATTEMPT REMOVAL OF THE DEVICE; HOWEVER, THIS WAS UNSUCCESSFUL. THE PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2020 WHERE THE DEVICE WAS REMOVED AND THE DEFECT CLOSED. 2600-A: OTHER - USED FOR CHEST PAIN.

  Patient problems: Chest Pain

  MAUDE report 11223409 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 44MM GORE® CARDIOFORM ASD OCCLUDER TO TREAT AN ATRIAL SEPTAL DEFECT ON (B)(6) 2020. AT THE PATIENT'S ONE MONTH FOLLOW-UP, IMAGING REVEALED THROMBUS ON THE RIGHT ATRIAL DISC. THE PATIENT HAS BEEN PRESCRIBED BLOOD THINNERS.

  Patient problems: Thrombus

  MAUDE report 10697289 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THE PHYSICIAN IMPLANTED A 44MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD). DURING DEPLOYMENT THE PATIENT DEVELOPED JUNCTIONAL HEART RHYTHM, WHICH BY THE END OF THE PROCEDURE HAD SPONTANEOUSLY CONVERTED BACK TO SINUS RHYTHM. DURING THE NIGHT, THE PATIENT DEVELOPED ASYMPTOMATIC TYPE 2 HEART BLOCK. THE PATIENT WAS TREATED WITH PREDNISONE AND HAD NO PREVIOUS HISTORY OF HEART BLOCK.

  Patient problems: Arrhythmia

  MAUDE report 10581871 ↗
• InjuryDec 10, 2019Expulsion; Positioning Problem; Expulsion; Positioning Problem

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 44MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT WITH A STATIC MEASUREMENT OF 15MM X 23MM AND AN INFERIOR RIM DEFICIENCY. THE DEFECT WAS NOT BALLOON SIZED. APPROXIMATELY TWO HOURS FOLLOWING THE PROCEDURE, THE DEVICE EMBOLIZED TO THE MAIN PULMONARY ARTERY. THE DEVICE WAS SUCCESSFULLY REMOVED WITH A SNARE. THE DEFECT WAS THEN BALLOON SIZED (NON STOP-FLOW METHOD) TO 36MM, AND A 36MM AMPLATZER SEPTAL OCCLUDER DEVICE WAS IMPLANTED WITH NO ADVERSE EFFECTS. THE PHYSICIAN AND A GORE FIELD SALES ASSOCIATE REVIEWED IMPLANT FLUOROSCOPIC IMAGING AND NOTED THAT IT APPEARED THE DEVICE WAS PROLAPSING ON THE INFERIOR RIM.

  Patient problems: No Code Available

  MAUDE report 9447684 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PHYSICIAN IMPLANTED A 44 MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT BALLOON SIZED TO 26 MM. THE EVENING OF THE PROCEDURE AN ECHOCARDIOGRAM SHOWED A RESIDUAL SHUNT THAT WAS NOT SEEN FOLLOWING DEVICE IMPLANT. THE PHYSICIAN REMOVED THE DEVICE IN A TRANSCATHETER PROCEDURE. THE DEFECT WAS NOT CLOSED AND THE PATIENT WILL LIKELY BE SENT TO SURGERY.

  Patient problems: No Code Available

  MAUDE report 9152538 ↗