Amplatzer™ Septal Occluder (REF 9-ASD-026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00811806010205), received between Sep 14, 2018 and Sep 25, 2026 — classified as 1 death, 26 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (46 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 25, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902160 ↗
• MalfunctionSep 11, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741327 ↗
• MalfunctionApr 24, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F NON-ABBOTT SHEATH. DURING PROCEDURE, WHILE DEPLOYMENT PHYSICIAN NOTED THAT THE DEVICE IS NOT TAKING ITS PROPER SHAPE, SO HE HAD TO RETRIEVE THE DEVICE BACK. THE PATIENT WAS HIV POSITIVE SO THEY HAD TO DISCARD THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984671 ↗
• MalfunctionMar 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F NON-ABBOTT SHEATH. DURING DEPLOYMENT PHYSICIAN NOTED THAT THE DEVICE IS NOT TAKING ITS PROPER SHAPE, SO HE HAD TO RETRIEVE THE DEVICE BACK. 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 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 24594166 ↗
• MalfunctionMar 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE PHYSICIAN DEPLOYED THE LEFT DISC OF THE DEVICE INSIDE THE LEFT ATRIUM (LA) BUT IT GOT A COBRA FORM. THEY REMOVED THE ENTIRE SYSTEM FROM THE PATIENT, RECOVERED THE DEVICE AND TRIED AGAIN BUT THE SAME THING HAPPENED. 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 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND THAT ONE ENDED UP WITH THE LEFT DISC LOOKING INFLATED (NOT FLAT). WITH A SOFT PUSH WITH THE SHEATH, THE DEVICE GOT THE PERFECT WAY AND FINALLY AFTER CHECKING EVERYTHING, THE DEVICE WAS RELEASED SUCCESSFULLY. 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 24594134 ↗
• MalfunctionMar 6, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM. WHILE DEPLOYMENT NOTED THAT THE DEVICE WAS NOT TAKING THE PROPER SHAPE AND HAD A COBRA DEFORMATION. THEY TRIED MULTIPLE TIMES BUT THE RESULTS REMAIN THE SAME. SO, THEY REMOVED THE DEVICE BACK. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE PROCEDURE GOT ABORTED. 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 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 24531532 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 26MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED USING AN 10 F AMPLATZER TREVISIO DELIVERY SYSTEM. THE PATIENT IS EXPERIENCING A PERSISTENT ALLERGIC REACTION OF UNKNOWN CHARACTERISTICS. THE IMPLANTING PHYSICIAN DID NOT KNOW WHEN THE SYMPTOMS BEGAN BUT INDICATED THAT HE WAS CONTACTED SEVERAL WEEKS AFTER THE SYMPTOMS HAD INITIATED. THE PATIENT IS CURRENTLY UNDERGOING EVALUATION BY AN ALLERGIST/IMMUNOLOGIST TO DETERMINE WHETHER THE REACTION MAY BE RELATED TO METAL OR NICKEL SENSITIVITY. THE IMPLANTING PHYSICIAN IS NOT AWARE OF ANY RESULTS FROM THE ALLERGIST AND IS NOT PRIVY TO ADDITIONAL INFORMATION REGARDING POTENTIAL METAL OR NICKEL ALLERGY TESTING. THERE WERE NO REPORTS OF ANAPHYLACTIC SHOCK; THE IMPLANTING PHYSICIAN ONLY DESCRIBED THE REACTION AS ¿SYSTEMIC.¿ THE SPECIFIC SYMPTOMS EXPERIENCED BY THE PATIENT WERE NOT KNOWN TO THE IMPLANTING PHYSICIAN. HE WAS ONLY INFORMED THAT THE PATIENT WAS EXPERIENCING SYSTEMIC REACTIONS. NO ISSUES WERE OBSERVED DURING THE IMPLANT PROCEDURE. NO IMPLANT COMPLICATIONS WERE REPORTED AT THE TIME OF THE PROCEDURE. ADDITIONALLY, THERE WERE NO ALLEGATIONS OF DEVICE MALFUNCTION OR PROCEDURAL CONCERNS. IT WAS ALSO REPORT

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24298511 ↗
• MalfunctionDec 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING THE PHYSICIAN NOTICED THAT THE DEVICE WAS NOT CONFORMING TO ITS DESIRED SHAPE AND THEREFORE THE DEVICE WAS RETRIEVED BACK. 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 23687951 ↗
• InjuryNov 26, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM FOR ATRIAL SEPTAL DEFECT (ASD) CLOSURE IN A 24-YEAR-OLD PATIENT WITH A DEFECT SIZE RANGING FROM 14 TO 24 MM. SEDATION WAS ADMINISTERED, AND THE ASD WAS ACCESSED USING A NON-ABBOTT CATHETER AND A COROWIRE. AN AMPLATZER SUPER STIFF WIRE WAS INTRODUCED THROUGH THE NON - ABBOTT CATHETER AND POSITIONED IN THE SUPERIOR PULMONARY VEIN. FLUOROSCOPIC IMAGING WAS USED TO CONFIRM WIRE PLACEMENT. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS INTENTIONALLY DEFERRED FOR LATER USE. THE DELIVERY SHEATH AND OCCLUDER WERE PREPARED, WITH ALL PRE-DEPLOYMENT CRITERIA MET: THE SHEATH WAS CONFIRMED TO BE FREE OF AIR, AND THE JUNCTION TEST BETWEEN THE DELIVERY CABLE AND OCCLUDER WAS SUCCESSFULLY COMPLETED. THE DELIVERY SHEATH WAS ADVANCED OVER THE AMPLATZER WIRE INTO THE LEFT ATRIUM AND POSITIONED WITHIN THE PULMONARY VEIN. DURING THE CONNECTION OF THE DEVICE TO THE SHEATH, SLIGHT LEFT ATRIAL PRESSURE WAS OBSERVED. NO BACKBLEEDING WAS INITIALLY NOTED; HOWEVER, A MINOR POSITIONAL ADJUSTMENT OF THE SHEATH RESULTED IN MINIMAL BACKBLEEDING. THE OCCLUDER WAS CONNECTED TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660844 ↗
• MalfunctionNov 7, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F NON-ABBOTT SHEATH. DURING THE DEPLOYMENT THE DEVICE PHYSICIAN NOTICED THAT THE DESIRED SHAPE WAS NOT TAKEN BY THE DEVICE, THAT¿S WHY THEY HAVE TO RETRIEVE THE DEVICE BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497952 ↗
• MalfunctionNov 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460690 ↗
• MalfunctionOct 30, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430684 ↗
• MalfunctionOct 23, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 26 MM AMPLATZER OCCLUDER WAS SELECTED FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE CLOSURE PROCEDURE, THE INITIALLY DEPLOYED OCCLUDER BECAME DEFORMED. THE DEVICE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING A NEW 28 MM AMPLATZER SEPTAL OCCLUDER. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372832 ↗
• InjuryOct 20, 2025Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED ON (B)(6) 2025 A 26MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). DURING THE PROCEDURE THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS SNARED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS CANCELED, AND THE PATIENT WAS TRANSFERRED TO SURGERY TO CLOSE THE ASD. 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 TO THE PROCEDURE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337645 ↗
• MalfunctionSep 29, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 26 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12 F AMPLATZER TREVISIO INVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER DEFORMED INTO COBRA HEAD DURING THE DEPLOYMENT OF THE LEFT ATRIAL DISC. THE DEVICE WAS ATTEMPTED TO DEPLOY MULTIPLE TIMES WITHIN THE LEFT ATRIUM, BUT THE DESIRED SHAPE WAS NOT RECOVERED. THE DEVICE WAS RETRACED INTO THE RIGHT ATRIUM AND THE BOTH DISCS WERE DEPLOYED BUT THE DESIRED SHAPE WAS NOT ACHIEVED. AFTER THE REMOVAL OF THE DISCS FROM THE PATIENT'S BODY , THE LEFT ATRIAL DISC REMAINED IN THE COBRA HEAD CONFIGURATION. THE PROCEDURE WAS COMPLETED USING A NEW 26MM AMPLATZER SEPTAL OCCLUDER. 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 23174918 ↗
• MalfunctionSep 22, 2025Difficult to Fold, Unfold or Collapse; Insufficient Device Problem Information; Difficult to Fold, Unfold or Collapse; Insufficient Device Problem Information

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23112047 ↗
• MalfunctionJul 18, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 26MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE DEVICE PRESENTED IN A COBRA DEFORMATION. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE TO RESOLVE THE EVENT. THERE WAS NO ANGULATION/KINK IN THE DELIVERY SYSTEM OR INTERACTION WITH CARDIAC STRUCTURES. THE PHYSICIAN DOESN'T BELIEVE THE PATIENT OR USER EXPERIENCED ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT'S CURRENT CONDITION IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546039 ↗
• MalfunctionJun 23, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 26MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F NON-ABBOTT DELIVERY SHEATH. 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 SHEATH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT 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 22308624 ↗
• MalfunctionApr 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 26MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN UNKNOWN NON-ABBOTT DELIVERY SHEATH. DURING THE PROCEDURE THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 26MM AMPLATZER SEPTAL OCCLUDER. 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 21830351 ↗
• MalfunctionMar 25, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 26MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F NON-ABBOTT DELIVERY SHEATH. IT WAS NOTED DURING PROCEDURE THAT THE OCCLUDER WAS NOT TAKING PROPER SHAPE WITH A COBRA DEFORMATION WHEN DEPLOYED. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE DECISION WAS MADE TO RECAPTURE AND REMOVE THE OCCLUDER FROM THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS ULTIMATELY ABORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692256 ↗
• MalfunctionJan 6, 2025Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Difficult to Advance; Difficult to Fold, Unfold or Collapse; Device Difficult to Setup or Prepare; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2024, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. WHEN PREPPING THE DEVICE THROUGH THE SHEATH, THE PHYSICIAN HAD AN ISSUE PULLING IT BACK INTO THE SHEATH. DURING PROCEDURE, WHEN THE DEVICE GOT DELIVERED, IT 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 DEVICE WAS REMOVED FROM THE BODY AND REPREPARED, THE FABRIC WAS NOT AROUND THE DEVICE AND MORE IN THE MIDDLE OF THE DEVICE. A NEW 28MM AMPLATZER SEPTAL OCCLUDER 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080008 ↗
• InjuryNov 7, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A 24MM ATRIAL SEPTAL DEFECT (ASD) CLOSURE USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE SIZING WAS DONE BY A 24MM SIZING BALLOON AND THE DEVICE SAT ODDLY WHEN DEPLOYED THE FIRST TIME. THE DEVICE WAS RESEARCHED AND DELIVERED A SECOND TIME. THE STABILITY TEST AND TUG TEST WAS PERFORMED WITH THE COMPLETE INTERROGATION BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) PROBE. THERE WAS NO LEAK NOTED AROUND THE LOBE OF THE DEVICE. ON ROUTINE FOLLOW UP AT 6 WEEKS, TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED THE POSTERIOR END OF THE DEVICE WAS FOUND TO BE SITTING PROUD AND THE RIGHT ATRIAL DISC WAS ON THE LEFT ATRIAL SIDE. THE DEVICE SHIFTED IN POSITION AND IT WAS FELT THAT THE DEVICE WAS AT RISK OF EMBOLIZATION. ON (B)(6) 2024, THE DEVICE WAS SURGICALLY REMOVED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20633823 ↗
• MalfunctionOct 4, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 26MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT, THE OCCLUDER DEFORMED INTO A COBRA SHAPE AND WAS NOT IMPLANTED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVER SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND REMOVED. A 26MM NON-ABBOTT DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372538 ↗
• MalfunctionSep 17, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 23 AUGUST 2024, A 26MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANT, AT THE SECOND TIME OF POSITIONING IN THE SEPTUM, COBRA DEFORMATION WAS OBSERVED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND WAS REMOVED. OUTSIDE THE PATIENT, THE OCCLUDER WAS CHECKED ON THE TABLE, BUT THE DEFORMATION PERSISTED. THE DEVICE WAS EXCHANGED FOR A NEW 24MM AMPLATZER SEPTAL OCCLUDER (LOT 10177515) WHICH WAS ATTEMPTED TO BE IMPLANTED USING THE SAME DELIVERY SYSTEM, HOWEVER THIS ALSO DEFORMED INTO A COBRA SHAPE. THERE WAS ALSO NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND WAS ALSO REMOVED. FINALLY, A NEW 24MM AMPLATZER SEPTAL OCCLUDER (LOT 10177515) WAS SUCCESSFULLY IMPLANTED USING THE SAME DELIVERY SYSTEM. THE PATIENT WAS REPORTED TO HAVE RECOVERED. THE PROCEDURE TIME WAS EXTENDED BY M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242398 ↗
• MalfunctionJul 25, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 26 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE GAINED A COBRA SHAPE DEFORMITY WHILE GETTING OUT FROM DELIVERY SYSTEM. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS RETURN TO ITS NORMAL SHAPE AFTER A FEW MANIPULATIONS. THE PHYSICIAN TRIED TO USE IT 2 MORE TIMES. HOWEVER, THE RESULT WAS THE SAME COULDN'T RETURN TO ITS NORMAL SHAPE AFTER MANIPULATIONS .THE PATIENT WAS REFER FOR SURGICAL ATRIAL SEPTAL DEFECT (ASD) CLOSURE. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828971 ↗