Amplatzer™ Septal Occluder (REF 9-ASD-028)Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00811806010212), received between Jun 11, 2018 and Sep 25, 2026 — classified as 2 deaths, 26 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (34 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 76 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 50901841 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 24 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING 10F AMPLATZER TREVISIO DELIVERY SYSTEM. COMPLEX ANATOMY WITH LARGE ATRIAL SEPTAL DEFECT. A DISCREPANCY WAS OBSERVED BETWEEN TEE AND FLUOROSCOPY MEASUREMENTS WHEN SIZING THE DEFECT WITH A BALLOON. THE 24 MM DEVICE WAS DEPLOYED FIRST; HOWEVER, A PERI-DEVICE LEAK WAS NOTED AROUND THE WAIST, AND THE DEVICE WAS SUBSEQUENTLY RETRIEVED. THE DEVICE WAS THEN UPSIZED TO A 28 MM AMPLATZER SEPTAL OCCLUDER. DURING DEPLOYMENT, A PORTION OF THE LEFT DISC WAS RELEASED INTO THE RIGHT ATRIUM, PROMPTING THE OPERATOR TO FULLY RECAPTURE THE DEVICE. DURING RECAPTURE, A STRUCTURE RESEMBLING A CLOT WAS VISUALIZED, APPEARING ATTACHED TO THE SEPTUM AND FLOATING WITHIN THE RIGHT ATRIUM. THE DEVICE AND DELIVERY SYSTEM WERE CAREFULLY REMOVED AND INSPECTED, AND NO CLOT WAS IDENTIFIED ON EITHER COMPONENT. THE PHYSICIAN SOUGHT A SECOND OPINION FROM COLLEAGUES, AND THE TEAM CONCLUDED THAT THE STRUCTURE WAS LIKELY A PARTIALLY DETACHED PIECE OF SEPTAL TISSUE. NO ASD DEVICE WAS IMPLANTED, AND THE PLAN WAS TO CONTINUE MONITORING THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE FOR THE DURATION OF THE PROCEDURE A

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24689631 ↗
• MalfunctionMar 12, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 10F NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING , THE PHYSICIAN NOTED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND TOOK FORM OF COBRA DEFORMATION. THEREFORE THEY HAD TO RETRIEVED IT BACK AND 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 24584293 ↗
• MalfunctionDec 9, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNSTABLE AND THE DEVICE 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 HAS BEEN POSTPONED AS DECIDED BY THE PHYSICIAN. 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 23762612 ↗
• MalfunctionNov 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622558 ↗
• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. THE OCCLUDER TOOK FORM COBRA FORMATION. 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 PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570406 ↗
• MalfunctionOct 23, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 29 SEPTEMBER 2025, A 28 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12 F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE FIRST DISC OF THE OCCLUDER FORMED A COBRA-LIKE DEFORMATION UPON INITIAL DEPLOYMENT. THE OCCLUDER CONTINUED TO DEFORM UPON RETRIEVAL OUTSIDE THE PATIENT AND COULD NOT BE USED, AS IT WAS UNABLE TO REGAIN ITS ORIGINAL 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/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 28 MM AMPLATZER SEPTAL OCCLUDER, AND IT PROCEEDED SMOOTHLY WITHOUT ANY ADVERSE OR DELAYED EFFECTS. 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 23373371 ↗
• InjuryOct 17, 2025Patient Device Interaction Problem; Premature Separation; Patient Device Interaction Problem; Premature Separation

  N/A.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322850 ↗
• MalfunctionSep 26, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23156915 ↗
• InjurySep 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  N/A.

  Patient problems: Angina; Perforation

  MAUDE report 23112946 ↗
• MalfunctionJul 8, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE DEVICE IMPLANTED WAS ATTEMPTED, BUT THEN REMOVED FROM THE PATIENT. WHEN IT WAS MANIPULATED, IT WAS NOTICED THAT THE POLYESTER SUTURE INSIDE THE OCCLUDER PROTRUDES AND FELL OUT. A NON-ABBOTT DEVICE WAS USED INSTEAD TO RESOLVE THE EVENT. 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 IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437129 ↗
• 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 22190414 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT. IT WAS REPORTED THAT DURING PROCEDURE, THE PATIENT DEVELOPED AN ONSET OF ATRIAL FIBRILLATION AND FLUTTER REQUIRING A 150 JOULE ELECTRIC SHOCK AND 150MG OF CORDARONE TO RETURN TO SINUS RHYTHM. THERE WAS NO DIFFICULTY IMPLANTING THE 28MM AMPLATZER SEPTAL OCCLUDER. AT AN UNKNOWN POINT IT WAS ALSO NOTED THAT THE PATIENT DEVELOPED LEFT VENTRICULAR EJECTION FRACTION IMPAIRMENT. THE PATIENT WAS ADMINISTERED A 20MG FUROSEMIDE BOLUS AND BEGAN RAPID PROGRESSIVE RECOVERY WITH INCREASED LEFT VENTRICULAR FILLING PRESSURES. ON (B)(6) 2025, IT WAS NOTED HAD DEVELOPED ACUTE RENAL FAILURE WITH CREATININEMIA. THIS RESULTED IN PROLONGED HOSPITALIZATION. THE PATIENT WAS HYDRATED AND GIVEN A POLYIONIC PERFUSION. THE CAUSE OF THE PATIENT'S INTRA-PROCEDURAL ATRIAL FIBRILLATION/FLUTTER IS CURRENTLY UNKNOWN. THE CAUSE OF THE PATIENT'S RENAL FAILURE AND LEFT VENTRICULAR EJECTION FRACTION IMPAIRMENT ARE ALSO CURRENTLY UNKNOWN. THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR PROCEDURE. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT. NO ADDITIONAL INF

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Failure/Congestive Heart Failure; Renal Failure

  MAUDE report 22090289 ↗
• MalfunctionMay 14, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING IMPLANT THE RIGHT ATRIAL DISC OF THE OCCLUDER TOOK ON A DEFORMED 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 IN 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 22019769 ↗
• MalfunctionApr 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 17 MAR. 2025, A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE DEVICE PRESENTED IN A COBRA DEFORMATION. THERE WAS NO ANGULATION OF KINKS IN THE DS OR INTERACTION WITH ANY CARDIAC STRUCTURES. THE DEVICE WAS REPLACED WITH A 30MM AMPLATZER SEPTAL OCCLUDER TO RESOLVE THE EVENT. 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 IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827693 ↗
• MalfunctionMar 14, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING DEVICE PREPARATION THAT THE OCCLUDER HAD A POLYESTER THREAD PROTRUDING FROM IT. IT WAS SPECIFICALLY NOTED WHEN STORING THE LOADER AFTER CONNECTING THE DELIVERY CABLE. THE OCCLUDER WAS NEVER RETRACTED FULLY/COMPLETELY INTO A DELIVERY SYSTEM. THE 28MM AMPLATZER SEPTAL OCCLUDER WAS NOT MISHANDLED OR DAMAGED AT ALL DURING DEVICE PREPARATION. AN ATTEMPT WAS MADE TO DEPLOY THE OCCLUDER IN THE PATIENT'S PATENT DUCTUS ARTERIOSUS, BUT WAS ULTIMATELY ABORTED. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 28MM AMPLATZER SEPTAL OCCLUDER WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606414 ↗
• MalfunctionDec 13, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN TO CLOSE AN ATRIAL SEPTAL DEFECT (ASD) USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEVICE WAS PREPARED BY THE PHYSICIAN AND LOADED INTO THE DELIVERY SYSTEM. BEFORE THE DELIVERY SYSTEM WAS INSERTED INTO THE PATIENT, THE DEVICE COULD SAFELY EXIT THE LOADER AND WAS THEN REINSERTED INTO THE LOADER. ONCE THE DEVICE WAS INSIDE THE PATIENT, THE LEFT DISC WAS DEPLOYED IN THE LEFT ATRIUM AND THE RIGHT DISC WAS RELEASED IN THE RIGHT ATRIUM. THE POSITIONING WAS NOT SATISFACTORY, SO THE DEVICE WAS RECAPTURED TWICE. ONCE THE LEFT DISC WAS DEPLOYED AGAIN, IT OPENED WITH THE DISTAL NOSE PORTION TOWARDS THE WAIST, ALMOST RESEMBLING A FLOWER SHAPE. WHEN THE DEVICE WAS ATTEMPTED TO BE RECAPTURED, THE DEVICE WOULD NOT RECAPTURE INTO THE SHEATH. THE DEVICE WAS MOSTLY RECAPTURED BUT NOT ENTIRELY. A WIRE WAS USED TO REMOVE THE SHEATH AND THE DEVICE FROM THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM. THE DEVICES WERE REPLACED WITH A NEW 28MM AMPLATZER SEPTAL OCCLUDER AND 10F AMPLATZER TREVISIO INTRAVASCULAR D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925398 ↗
• MalfunctionNov 21, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE HAD A COBRA FORMATION MULTIPLE TIMES DURING IMPLANTATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN, BUT HAD THE SAME COBRA DEFORMATION. 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 26MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748007 ↗
• InjuryNov 11, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 28 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). THE ASD WAS MEASURED AT 25 MM THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND STOPPED-FLOW TECHNIQUE. ANGIOGRAPHY AND TEE WERE USED DURING THE PROCEDURE. A STABILITY TEST WAS PERFORMED. THE DEVICE WAS RE-CAPTURED ONCE FOR OPTIMAL POSITIONING. THE DEVICE WAS IMPLANTED. APPROXIMATELY FOUR HOURS POST-PROCEDURE IT WAS NOTED UNDER TRANSTHORACIC ECHOCARDIOGRAM (TTE) THAT THE DEVICE EMBOLIZED TO THE LEFT ATRIUM. THE DEVICE WAS CAPTURED VIA TRANSCATHETER SNARE FROM THE LEFT ATRIUM. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653795 ↗
• MalfunctionOct 21, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT BOTH DISCS OF THE DEVICE TOOK ON A COBRA SHAPE. SEVERAL ATTEMPTS WERE MADE TO RE-DEPLOY THE DEVICE, HOWEVER THE DEVICE DID NOT CONFORM TO ITS ORIGINAL SHAPE. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 30MM AMPLATZER SEPTAL OCCLUDER. DURING IMPLANT IT WAS DETERMINED THAT THE DEVICE WAS TOO BIG AND DID NOT OPTIMALLY FIT IN THE INTERATRIAL SEPTUM. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 26MM AMPLATZER SEPTAL OCCLUDER. THE DEVICE FIT WELL WITH THE PATIENT ANATOMY AND WAS IMPLANTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN 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 20495930 ↗
• MalfunctionSep 23, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THIS REPORT IS FOR THE SECOND 28MM AMPLATZER SEPTAL OCCLUDER. IT WAS REPORTED THAT ON 30 AUGUST 2024, A 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) PROCEDURE USING AN UNKNOWN ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, THE LEFT DISC OF THE DEVICE HAD A BULBOUS DEFORMATION. THE DEFORMED FIRST 28MM DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW 28MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN HAD THE SAME ISSUE. THE DEFORMED SECOND 28MM DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. A NEW NON-ABBOTT DEVICE WAS CHOSEN AND COMPLETED THE PROCEDURE. 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 20280767 ↗
• MalfunctionSep 23, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280746 ↗
• MalfunctionAug 30, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZED ABBOTT UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, THE DISCS DEFORMED WITH A BULBOUS SHAPE AND WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20112528 ↗
• MalfunctionAug 29, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 10F NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 30MM AMPLATZER SEPTAL OCCLUDER. DURING IMPLANT THE DEVICE ALSO TOOK ON A DEFORMED SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS POSTPONED. THERE WAS SOME INTERACTION WITH CARDIAC STRUCTURES DURING THE PROCEDURE. 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 IN 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 20100498 ↗
• MalfunctionAug 23, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM (DS). WHILE THE DEVICE WAS DEPLOYED, IT DEFORMED INTO A COBRA DEFORMATION. THE DEVICE WASN'T RELEASED FROM THE DELIVERY CABLE AND WAS REPLACED WITH A 28MM NON-ABBOTT DEVICE TO RESOLVE THE EVENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES OR ANGULATION/KINK NOTED IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048948 ↗