Amplatzer™ Septal Occluder (REF 9-ASD-030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00811806010229), received between Sep 11, 2018 and Sep 18, 2026 — classified as 1 death, 18 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (47 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 30mm Amplatzer Septal Occluder was chosen for implant using a non-Abbott delivery system. During the procedure, it was noted that the occluder conformed to cobra headed shape. The deformed device was never released from the delivery cable while inside the patient. There was no angulation or kink noted in the delivery system. There was no interaction with cardiac structures during deployment. The procedure was completed using an alternate device. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819451 ↗
• MalfunctionJul 10, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2025 that a 30 mm Amplatzer Septal Occluder was chosen for implant using a 10F Amplatzer Torqvue Delivery System. It was noted that the both the discs of the occluder were observed in Cobra shape. The deformed device was never released from the delivery cable while inside the patient. There was no angulation or kink noted in the delivery system. There was no interaction with cardiac structures during deployment. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785830 ↗
• MalfunctionMay 12, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 12F AMPLATZER TREVISIO DELIVERY SYSTEM. PRE-PROCEDURAL SIZING WAS PERFORMED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), WHICH MEASURED THE DEFECT AT 26 MM. BASED ON THIS MEASUREMENT, THE PHYSICIAN ELECTED TO USE A 30 MM DEVICE. DURING THE FIRST DEPLOYMENT ATTEMPT, THE OCCLUDER¿S LEFT ATRIAL DISC OPENED WITH A COBRA HEAD DEFORMITY. THE PHYSICIAN RETRIEVED THE DEVICE, RINSED, AND RELOADED IT. AFTER RELOADING, THE DEVICE INITIALLY APPEARED TO RETURN TO A NORMAL CONFIGURATION. DURING THE SECOND DEPLOYMENT ATTEMPT, THE COBRA HEAD DEFORMITY OF THE LEFT DISC REOCCURRED. THE PHYSICIAN RETRIEVED THE DEVICE AGAIN, WITH A TOTAL OF THREE RETRIEVAL ATTEMPTS PERFORMED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. DUE TO THE REPEATED DEFORMITY, THE PHYSICIAN DECIDED TO OPEN A NEW 30MM AMPLATZER SEPTAL OCCLUDER OF THE SAME SIZE . THE REPLACEMENT DEVICE WAS DEPLOYED SUCCESSFULLY WITH NO COBRA HEAD DEFORMITY OBSERVED. THE ASD CLOSURE WAS COMPLETED S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156571 ↗
• MalfunctionApr 21, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. PRE-PROCEDURE MEASUREMENTS WERE TAKEN BY USING A LARGE ASD BALLOON WITH SIZES RANGING FROM 28MM TO 30MM ON AN ECHO/ FLUORO IMAGING. INITIALLY A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT BUT THEN DETERMINED TO BE OVERZISED, LATER IT WAS DOWNSIZED TO A 30MM AMPLATZER SEPTAL OCCLUDER, WHICH AFTER MULTIPLE DEPLOYMENTS CONFORMED INTO A COBRA LIKE DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT PROBABLY IN LEFT ATRIUM AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A 28MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24934266 ↗
• MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2026 A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F NON-ABBOTT DELIVERY SHEATH. DURING DEPLOYMENT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY SYSTEM AND WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24546429 ↗
• MalfunctionMar 3, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE POSITIONING, THE LEFT ATRIAL DISC ASSUMED AN INCORRECT FORM (COBRA SHAPE). THE DEVICE WAS NOT IMPLANTED AND REMOVED FROM THE PATIENT. A NEW 30MM AMPLATZER SEPTAL OCCLUDER WAS USED AND IMPLANTED SUCCESSFULLY USING THE FIRST DELIVERY SYSTEM. THE PATIENT DID NOT EXPERIENCED ANY ADVERSE CONSEQUENCES AND THIS EVENT WAS NOT ATTRIBUTED TO PATIENT ANATOMY. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501544 ↗
• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION. A NEW 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470497 ↗
• MalfunctionFeb 24, 2026Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434435 ↗
• MalfunctionJan 30, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND CONFORMED INTO A COBRA-LIKE DEFORMATION ON THE LEFT DISC. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223724 ↗
• MalfunctionJan 5, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 12F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE IT WAS OBSERVED THAT OCCLUDDER CONFORMED INTO A COBRA LIKE DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 30MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967658 ↗
• MalfunctionDec 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE PHYSICIAN OBSERVED THE DEVICE WAS NOT CONFORMING TO ITS DESIRED SHAPE. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW 30MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888489 ↗
• MalfunctionDec 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824971 ↗
• InjuryDec 5, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING THE RIGHT ATRIAL DISC AFTER THE LEFT ATRIAL DISC WAS DEPLOYED, THE DEVICE COMPLETELY DETACHED FROM THE DELIVERY CABLE. THE CABLE CONNECTION WAS CHECKED DURING PREP AD PRIOR TO DEPLOYMENT. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO CARDIAC SURGERY, WHERE A SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE DEVICE AND CLOSE THE PATH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732797 ↗
• MalfunctionNov 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 14F NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING, THE PHYSICIAN NOTED THAT THE DEVICE WAS NOT CONFORMING TO ITS INTENDED SHAPE, THE DEVICE TOOK FORM OF COBRA DEFORMATION. THE RIGHT ATRIAL DISC WAS GETTING DEFORMED DURING DEPLOYMENT, EVEN AFTER MULTIPLE ATTEMPTS. THE DEFORMED DEVICE WAS RETRIEVED BACK. THE PROCEDURE WAS ABORTED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY SYSTEM WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURE DURING DEPLOYMENT AND NO ANGULATION/KINK WAS NOTICED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460691 ↗
• MalfunctionOct 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381421 ↗
• MalfunctionSep 29, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F NON-ABBOTT DEVICE. DURING THE PROCEDURE, THE PHYSICIAN NOTICED A COBRA FORMATION ON THE LEFT DISC AND THE ISSUE PERSISTED EVEN AFTER MULTIPLE ATTEMPTS. THE CASE WAS POSTPONED TO A LATER DATE. IT IS NOTED THAT THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN DELIVERY SYSTEM. IT WAS OBSERVED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23174913 ↗
• InjurySep 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE IN 2017 A 30MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. ON (B)(6)2025 THE DEVICE WAS ERODED.

  Patient problems: Erosion

  MAUDE report 23123955 ↗
• InjurySep 19, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025 A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WERE USED DURING THE PROCEDURE. THE ASD WAS MEASURED AT 26MM. THE DEVICES WERE PREPARED PER INSTRUCTIONS FOR USE (IFU). THE CABLE CONNECTION WAS CHECKED DURING DEVICE PREPARATION AND PRIOR TO DEPLOYMENT. DURING THE PROCEDURE THE OCCLUDER PREMATURELY DISCONNECTED FROM THE DELIVERY CABLE WHEN THE CABLE WAS GENTLY PULLED BACK TO THE DELIVERY SYSTEM. THE OCCLUDER CAUSED A PARTIAL BLOCKAGE OF BLOOD FLOW IN THE LEFT PULMONARY ARTERY. AN ATTEMPT WAS MADE TO SNARE THE OCCLUDER BUT WAS UNSUCCESSFUL. THE PATIENT UNDERWENT SURGERY TO REMOVE THE DEVICE AND CLOSE THE ASD. THE PATIENT STATUS WAS STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23097311 ↗
• MalfunctionSep 5, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A NEW 30MM NON-ABBOTT DEVICE WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22978598 ↗
• MalfunctionAug 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON UNKNOWN DATE, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THE PROCEDURE GOT TERMINATED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22689396 ↗
• MalfunctionJun 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN AMPLATZER SEPTAL OCCLUDER (ASO) WAS CHOSEN FOR IMPLANTATION. A 30MM ASO WAS ATTEMPTED TO BE IMPLANTED BUT DEFORMED INTO A COBRA SHAPE. A REPLACEMENT 32MM ASO WAS THEN ATTEMPTED BUT ALSO DEFORMED INTO A COBRA SHAPE. THE PROCEDURE WAS ABORTED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325031 ↗
• MalfunctionJun 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190411 ↗
• MalfunctionMay 23, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS DURING THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080144 ↗
• InjuryMay 19, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025, A 10MM AND A 30MM AMPLATZER ATRIAL SEPTAL OCCLUDER (ASO) WERE CHOSEN FOR IMPLANTATION INTO A COMPLEX AND FENESTRATED SEPTUM ANATOMY. A 34MM AMPLATZER SIZING BALLOON WAS USED. A 7F AMPLATZER TREVISO DELIVERY SHEATH WAS UTILIZING WITH THE 10MM ASO AND A 12F AMPLATZER TREVISIO DELIVERY SHEATH WAS USED WITH THE 30MM ASO. BOTH OCCLUDERS PASSED THE TENSION TEST AND WERE DEPLOYED. THE FOLLOWING MORNING, THE PATIENT WAS EXPERIENCING ARRHYTHMIA EPISODES WHEN LYING ON SIDE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED WHICH REVEALED THE 30MM OCCLUDER HAS EMBOLIZED INTO THE LEFT VENTRICLE. THE 10MM OCCLUDER WAS STILL IN PLACE. LATER THAT AFTERNOON, SURGICAL INTERVENTION WAS PERFORMED. BOTH OCCLUDERS WERE REMOVED AND THE SEPTUM WAS SURGICALLY CORRECTED. THERE WAS NO ISSUE WITH THE 10MM ASO. THE PATIENT WAS REPORTED TO BE HOSPITALIZED AND RECOVERING.

  Patient problems: Coronary obstruction/occlusion; Embolism/Embolus

  MAUDE report 22044585 ↗
• MalfunctionMay 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING PROCEDURE, COBRA DEFORMATION WAS OBSERVED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND REMOVED. IT WAS EXCHANGED FOR A NEW UNKNOWN SIZED NON-ABBOTT DEVICE, WHICH WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038225 ↗