Amplatzer™ Septal Occluder (REF 9-ASD-032)Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00811806010236), received between Jul 23, 2018 and Sep 25, 2026 — classified as 17 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (67 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 101 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 50901838 ↗
• MalfunctionJul 13, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (b)(6) 2026, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTE. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER FORMED COBRA SHAPE. THE PROCEDURE WAS ABORTED. 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 25808030 ↗
• MalfunctionMar 17, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6), A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING DEPLOYMENT, THE LEFT ATRIAL (LA) DISC FORMED NORMALLY AND LAID FLAT AGAINST THE SEPTUM; HOWEVER, WHEN THE RIGHT ATRIAL (RA) DISC WAS DEPLOYED, IT DID NOT LAY FLAT AND APPEARED PUFFY. AFTER TWO ADDITIONAL ATTEMPTS TO RECAPTURE AND REDEPLOY, THE RA DISC CONTINUED TO EXHIBIT THE SAME BEHAVIOR. THE DEVICE WAS THEN FULLY RETRACTED INTO THE DELIVERY SYSTEM AND REMOVED FROM THE PATIENT. THE TEAM INSPECTED THE DEVICE ON THE BACK PREPARATION TABLE AND DEPLOYED IT IN A LARGE BOWL OF SALINE, WHERE THE LA DISC AGAIN FORMED NORMALLY WHILE THE RA DISC REMAINED PUFFY, GIVING THE DEVICE AN OVERALL MUSHROOM-LIKE APPEARANCE. THE PHYSICIAN LIGHTLY MASSAGED THE DEVICE UNDER SALINE IN AN ATTEMPT TO RESTORE ITS SHAPE. THE DEVICE WAS THEN PREPPED AGAIN AND REDEPLOYED IN THE PATIENT, BUT THE RA DISC CONTINUED NOT TO FORM PROPERLY. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE DEVICE AND DELIVERY SYSTEM WERE REMOVED, AND THE PROCEDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621582 ↗
• MalfunctionMar 3, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM. IT WAS OBSERVED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE BUT WAS FORMING COBRA 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 ABORTED. 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 24503109 ↗
• MalfunctionFeb 17, 2026Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2026, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 13F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING, THE PHYSICIAN NOTED THAT THE OCCLUDER CONFORMED INTO COBRA-LIKE DEFORMATION. THE OCCLUDER WAS RELEASED OUTSIDE AND WHEN ATTEMPTED TO RELEASE AGAIN OUTSIDE THE OCCLUDER CONFORMED INTO COBRA DEFORMATION EVEN AFTER THREE ATTEMPTS. 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. A SECOND 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING THE SAME DELIVERY SYSTEM AND WHEN DEPLOYING THE NEW OCCLUDER, IT CONFORMED INTO COBRA DEFORMATION. THE PHYSICIAN LATER RELEASED IT OUTSIDE THE BODY AND ATTEMPTED TO RELEASE TWICE OUTSIDE THE PATIENT'S BODY AND THE OCCLUDER WAS STILL DEFORMED INTO COBRA. THE PHYSICIAN, THEN MANUALLY RESHAPED THE OCCLUDER TO RESTORE TO ITS NORMAL CONFIGURATION AND AFTER TWO SUCCESSFUL RELEASES OUTSIDE THE PATIENT'S BODY, IT WAS IMPLANTED INTO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370489 ↗
• MalfunctionFeb 17, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 13F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING, THE PHYSICIAN NOTED THAT THE OCCLUDER CONFORMED INTO COBRA-LIKE DEFORMATION. THE OCCLUDER WAS RELEASED OUTSIDE AND WHEN ATTEMPTED TO RELEASE AGAIN OUTSIDE THE OCCLUDER CONFORMED INTO COBRA DEFORMATION EVEN AFTER THREE ATTEMPTS.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. A SECOND 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING THE SAME DELIVERY SYSTEM AND WHEN DEPLOYING THE NEW OCCLUDER, IT CONFORMED INTO COBRA DEFORMATION. THE PHYSICIAN LATER RELEASED IT OUTSIDE THE BODY AND ATTEMPTED TO RELEASE TWICE OUTSIDE THE PATIENT'S BODY AND THE OCCLUDER WAS STILL DEFORMED INTO COBRA. THE PHYSICIAN, THEN MANUALLY RESHAPED THE OCCLUDER TO RESTORE TO ITS NORMAL CONFIGURATION AND AFTER TWO SUCCESSFUL RELEASES OUTSIDE THE PATIENT'S BODY, IT WAS IMPLANTED INTO THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370486 ↗
• MalfunctionFeb 13, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335028 ↗
• MalfunctionFeb 2, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2026, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 12F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING, IT WAS OBSERVED THAT THE OCCLUDER DID NOT CONFORM TO ITS DESIRED SHAPE AND TOOK FORM OF A COBRA 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 ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240461 ↗
• MalfunctionJan 22, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE DEVICE CONFORMED INTO A COBRA-LIKE DEFORMATION. THE PROCEDURE WAS COMPLETED USING A NON-ABBOT DEVICE. 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 WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152209 ↗
• MalfunctionJan 20, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 12F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER CONFORMED INTO A COBRA-LIKE DEFORMATION. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. 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 24122575 ↗
• MalfunctionDec 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED BY THE PHYSICIAN THAT THE DEVICE DID NOT CONFORM TO ITS DESIRED SHAPE AND TOOK FORM OF A COBRA DEFORMATION. THE PROCEDURE WAS COMPLETED BY USING A NEW 32MM 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 23888491 ↗
• MalfunctionDec 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 30 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 12F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE OCCLUDER INSIDE THE PATIENT, THE DEVICE ASSUMED A COBRA-LIKE SHAPE AND DID NOT REVERT TO ITS ORIGINAL CONFIGURATION. THE TEAM RETRACTED THE DEVICE AND ATTEMPTED TO RELEASE IT OUTSIDE THE PATIENT; HOWEVER, THE DEVICE REMAINED IN THE COBRA SHAPE. AFTER RINSING THE DEVICE WITH SALINE AND GENTLY MANIPULATING IT, THE DEVICE EVENTUALLY RETURNED TO ITS ORIGINAL FORM. INTERNAL DAMAGE WAS NOTED, INCLUDING A BENT WIRE AND COMPROMISED MESH. SUBSEQUENTLY, THE TEAM ATTEMPTED TO REPLACE THE DEVICE WITH 32 MM AMPLATZER SEPTAL OCCLUDER. THE SAME ISSUE OCCURRED, WITH THE DEVICE FORMING A COBRA SHAPE AND FAILING TO RETURN TO ITS INTENDED CONFIGURATION. AFTER TWO OCCURRENCES OF THIS ISSUE, THE PHYSICIANS DECIDED TO RETRACT THE DEVICE AND PROCEED WITH A NON- ABBOTT ASD CLOSURE DEVICE. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS INTERACTION WITH THE CARDIAC STRUCTURES AS IT WAS DEPLOYED INSIDE THE LEFT ATRIAL AND IT TOUCHED ATRIAL SEPTAL. NO ANGUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824989 ↗
• MalfunctionOct 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 32 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 12 F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING, THE OCCLUDER DEFORMED INTO A COBRA SHAPE. 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 THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 32 MM AMPLATZER SEPTAL OCCLUDER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381249 ↗
• MalfunctionAug 28, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 32MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 13F NON-ABBOTT SHEATH. DURING THE PROCEDURE THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE AND 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 22914153 ↗
• InjuryAug 28, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING PROCEDURE, BOTH LEFT AND RIGHT DISCS OF THE OCCLUDER DEFORMED INTO COBRA FORMATION AND THE PHYSICIAN COULD NOT RETRIEVE THE DEVICE BACK. THERE WAS NO REPORT OF ANY INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. THERE WAS NO ISSUES NOTED ON THE DELIVERY SYSTEM. THE PATIENT WAS SENT FOR SURGICAL REMOVAL OF THE DEVICE. 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 22911872 ↗
• MalfunctionAug 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE DEVICE HAD A COBRA FORMATION. 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 GOT ABORTED. 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 22865977 ↗
• MalfunctionAug 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 32MM 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. A NEW 32MM 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 AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839743 ↗
• MalfunctionAug 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815099 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) - SH DEVICE REGISTRY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 32MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR PROCEDURE. INITIALLY, A 22MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS ATTEMPTED AFTER SIZING THE DEFECT WITH AN 18.19MM WAIST, BUT DUE TO A FLOPPY POSTERIOR SEPTUM AND RESIDUAL SHUNT, THE DEVICE WAS NOT STABLE. IT WAS UNEVENTFULLY RECAPTURED, AND THE 32MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, IT'S NOTED THAT THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK. THE EVENT LASTED APPROXIMATELY FOUR HOURS AND WAS CONFIRMED THROUGH A NEUROLOGICAL EXAM IN THE EMERGENCY DEPARTMENT, WHERE THE PATIENT PRESENTED WITH ACUTE ONSET HEMIHYPESTHESIA. A MAGNETIC RESONANCE IMAGING SCAN AND CRANIAL COMPUTED TOMOGRAPHY SCAN RULED OUT ACUTE CEREBRAL INFARCTION, AND SYMPTOMS COMPLETELY RESOLVED WITHIN A FEW HOURS. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS BUT EXPERIENCED NO OTHER CLINICAL SIGNS OR SYMPTOMS AND DID NOT SUSTAIN ANY PERMANENT INJURY OR DISABILITY. NO INTERVENTION WAS PERFORMED OR PLANNED DUE TO THE EVENT. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE IMPLANTING PHYSICI

  Patient problems: Transient Ischemic Attack

  MAUDE report 22690004 ↗
• MalfunctionAug 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F NON-ABBOTT SHEATH. DURING DEPLOYMENT, THE PHYSICIAN NOTED THAT THE DEVICE WAS 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 PROCEDURE GOT TERMINATED. 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 22689854 ↗
• MalfunctionJul 3, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394849 ↗
• 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 22325013 ↗
• MalfunctionJun 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 32MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 6F NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE AND 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 CLINICALLY SIGNIFICANT DELAYS TO 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 22320841 ↗
• MalfunctionJun 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 28 MAY 2025, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION WHEN ATTEMPTED TO BE IMPLANTED. 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 32MM 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 22292600 ↗
• InjuryApr 9, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 4 YEAR OLD PATIENT BROUGHT TO THE CARDIAC CATHETERIZATION (CATH) LABORATORY FOR PATENT DUCTUS ARTERIOSUS (PDA) AND ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE. THE PDA CLOSURE WAS DONE FIRST AND WITHOUT INCIDENT USING A 3 MM X 6 MM AMPLATZER PICCOLO OCCLUDER. NEXT ASD WAS CLOSURE ATTEMPTED WITH A 25MM AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM. UPON DEPLOYMENT OF THE OCCLUDER ON THE SEPTUM, THE PATIENT WAS NOTED TO HAVE DEVELOPED 2ND DEGREE HEART BLOCK. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, AND WAS OBSERVED FOR APPROXIMATELY 10MINS AT WHICH POINT CONVERTED SPONTANEOUSLY BACK TO NORMAL SINUS RHYTHM. THE DEVICE WAS THEN RELEASED FROM THE CABLE AND THE PATIENT WAS NOTED TO HAVE GONE BACK IN SECOND DEGREE HEART BLOCK. THE PATIENT WAS AGAIN MONITORED AND ELECTROPHYSIOLOGIST (EP) WAS CONSULTED. THE RECOMMENDATION WAS MADE TO ADMINISTER A DOSE OF STEROIDS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND EVENTUALLY CONVERTED BACK TO NORMAL SINUS RHYTHM APPROXIMATELY 30 MINUTES AFTER THE DEVICE WAS RELEASED. THE PATIENT WAS SENT BACK TO THE ROOM AND KEEP ON TELEMETRY MONITORING OVER NIGHT. THE NEXT MORNING THE PATIENT WAS NOTED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21806454 ↗