Amplatzer™ Septal Occluder (REF 9-ASD-008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00811806010052), received between Aug 27, 2018 and Feb 27, 2026 — classified as 16 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (41 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION. THE DEVICE WAS RETRIEVED AND TESTED OUTSIDE THE PATIENT. THE DEVICE WAS DEPLOYED OUTSIDE THE PATIENT AND THE COBRA DEFORMATION KEPT HAPPENING THE ANATOMY WAS COMPLEX AND THE LEFT DISC WAS INTERFERING WITH THE ATRIAL WALL CLOSE TO THE AORTA. A NEW 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN. THE PHYSICIAN MANAGED TO CHANGE THE POSITION OF THE DELIVERY SHEATH SO THAT THE LEFT DISC WAS LESS INTERFERING WITH THE STRUCTURES DURING DEPLOYMENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO ADVERSE CONSEQUENCE REPORTED. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469633 ↗
• MalfunctionJan 16, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYMENT, IT WAS NOTED THAT THE LEFT DISC OF THE OCCLUDER WAS CONFORMING INTO A COBRA-LIKE DEFORMATION. IT WAS ATTEMPTED TWICE AND THE SAME ISSUE PERSISTED AND THEREFORE THE PHYSICIAN HAD TO RETRIEVE THE DEVICE BACK. 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 24098828 ↗
• MalfunctionJan 7, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995849 ↗
• MalfunctionNov 26, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DEFORMED INTO A COBRA-LIKE DEFORMATION WHILE OPENING THE LEFT ATRIAL DISC WHEN THE DELIVERY SYSTEM WAS INSIDE THE PATIENT. 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 10MM 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 23660776 ↗
• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8MM AMPLATZER SEPTAL OCCLUDER AND 18MM AMPLATZER CRIBRIFORM WAS CHOSEN FOR IMPLANT FOR ATRIAL SEPTAL DEFECT SEQUENTIALLY USING A 8F AMPLATZER TREVISIO DELIVERY SYSTEM. THE DEFECT SIZE WAS MEASURED USING AN INTRACARDIAC ECHOCARDIOGRAPHY(ICE) CATHETER. DURING THE PROCEDURE, WHEN THE DEVICE WAS EXPANDING INSIDE THE PATIENT, THE OCCLUDER DEFORMED INTO A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. IT WAS NOTED THAT CONTACTS OCCURRED WITH INTRACARDIAC TISSUE DURING THE OCCLUDER DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING A 25MM AMPLATZER CRIBRIFORM 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 23573141 ↗
• MalfunctionNov 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571000 ↗
• MalfunctionSep 19, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025 A 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7 F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE SHIRT HAD CAUSED THE OCCLUDER TO TAKE FORM OF A COBRA DEFORMATION ON TWO OCCASIONS , THE FIRST TIME THE COBRA DEFORMATION OCCURRED INSIDE THE PATIENT AND SECOND TIME BEFORE THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PROCEDURE WAS COMPLETED USING A NEW 8MM AMPLATZER SEPTAL OCCLUDER WITH 7 F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE PATIENT IS REPORTED TO BE STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100971 ↗
• MalfunctionAug 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 22708299 ↗
• MalfunctionJul 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR PROCEDURE. IT WAS NOTED DURING PROCEDURE THAT LEFT DISC OF THE OCCLUDER EXHIBITED A DEFORMATION. THE DEFORMED OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE DECISION WAS MADE TO RECAPTURE, REMOVED, AND REPLACE THE 8MM AMPLATZER SEPTAL OCCLUDER WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403869 ↗
• MalfunctionJun 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. 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 8MM 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 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 22235502 ↗
• MalfunctionMay 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE WAS DEFORMED (LEFT DISC IN COBRA) UPON DELIVERY. THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. 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 9MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027968 ↗
• MalfunctionApr 25, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION WHEN IT WAS DEPLOYED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS REPORT OF INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND THERE WAS NO REPORT OF REPORT OF ANY ANGULATION/KINK NOTICED WITH THE DELIVERY SYSTEM. A NEW 8MM 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 21909494 ↗
• MalfunctionMar 24, 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 AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE WHILE IN THE LEFT ATRIUM. THE OCCLUDER AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND A NEW 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM WAS USED WITH THE SAME OCCLUDER. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE AGAIN. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 10MM AMPLATZER SEPTAL OCCLUDER. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE. 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 21677641 ↗
• InjuryJan 13, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 TO TREAT AN ATRIAL SEPTAL DEFECT. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) MEASURED THE DEFECT AS 5-7MM AND ACCORDING TO A SIZING BALLOON IT WAS 7MM. ANGIOGRAPHY AND TEE WERE USED DURING THE PROCEDURE. A STABILITY CHECK WAS PERFORMED. DURING THE PROCEDURE IT WAS NOTED THAT UPON RELEASING THE OCCLUDER FROM THE DELIVERY CABLE, THE OCCLUDER EMBOLIZED TO THE LEFT ATRIUM. THE OCCLUDER WAS ABLE TO REMOVED FROM THE PATIENT WITH A TRANSCATHETER SNARE. A NEW NON-ABBOTT PFO OCCLUDER WAS IMPLANTED. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE USER BELIEVED THE EMBOLIZATION OCCURRED DUE TO THE DEVICE SIZING TOO SMALL AND IMAGING NOT PROPERLY DONE. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138406 ↗
• MalfunctionDec 30, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE LEFT ATRIAL DISC OF 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 10MM AMPLATZER SEPTAL OCCLUDER DUE TO THE 8MM SIZE BEING OUT OF STOCK. 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 21036750 ↗
• MalfunctionDec 13, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, COBRA DEFORMATION WAS OBSERVED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT AND WAS REMOVED. NO DEVICE WAS ULTIMATELY IMPLANTED AND THE DEFECT WAS CLOSED VIA SURGICAL PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924549 ↗
• MalfunctionNov 15, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). DURING IMPLANT THE DEVICE TOOK ON A COBRA HEAD SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE WAS RE-DEPLOYED OUTSIDE OF THE PATIENT AND THE DEVICE WAS CONFORMED BACK TO ITS ORIGINAL SHAPE. THE DEVICE WAS RE-INSERTED AND DEPLOYED ONCE MORE, HOWEVER THE LEFT ATRIAL DISC FORMED A COBRA HEAD SHAPE WHILE IN THE LEFT ATRIUM. THE DELIVERY SHEATH WAS RE-POSITIONED FROM THE ATRIAL SEPTAL DEFECT TO THE RIGHT ATRIUM. THE DEVICE WAS DEPLOYED ONCE MORE BUT THE LEFT ATRIAL DISC FORMED A COBRA HEAD SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 8MM AMPLATZER SEPTAL OCCLUDER USING THE SAME DELIVERY SYSTEM. THERE WAS SOME INTERACTION WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695940 ↗
• MalfunctionNov 4, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT, THE OCCLUDER DEFORMED WITH A COBRA SHAPE. 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 AND REMOVED FROM THE PATIENT. THE 7F DELIVERY SHEATH WAS EXCHANGED FOR A NEW 6F AMPLATZER DELIVERY SHEATH, HOWEVER THE DEFORMATION PERSISTED. A NEW 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING THE SAME 6F DELIVERY SHEATH AND WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605334 ↗
• MalfunctionAug 23, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 8MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) PROCEDURE USING AN UNKNOWN SIZE ABBOTT DELIVERY SYSTEM. DURING PROCEDURE, THE LEFT DISC OF THE DEVICE NOT IN A RIGHT SHAPE HAD A BULBOUS 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. THEY CANCELLED THE PROCEDURE AND PATIENT WAS SENT FOR SURGERY. 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 20045763 ↗
• MalfunctionJul 22, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, WHILE THE DEVICE WAS BEING DEPLOYED, IT PRESENTED IN A COBRA DEFORMATION WHILE EXPOSING THE LEFT ATRIAL DISC. THE DEVICE WAS RECAPTURED AND TRIED AGAIN, BUT THE DEFORMATION PERSISTED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 8MM AMPLATZER SEPTAL OCCLUDER TO RESOLVE THE EVENT. THE DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE AND THERE WAS NO KINK IN THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802726 ↗
• MalfunctionJun 20, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING DEPLOYMENT INSIDE THE PATIENT, THE OCCLUDER DEFORMED INTO A COBRA SHAPE. THE OCCLUDER WAS RE-SHEATHED AND RE-DEPLOYED 3 TIMES, HOWEVER THE DEFORMATION PERSISTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE CABLE WHILE INSIDE THE PATIENT. A NEW 10MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575686 ↗
• MalfunctionJun 12, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, WHILE THE LEFT ATRIAL DISC WAS BEING DEPLOYED, IT PRESENTED IN A COBRA DEFORMATION. THE DEVICE WAS RECAPTURED AND REMOVED. THE DEVICE WAS THEN TESTED ON THE BENCH AND THE COBRA DEFORMATION CONTINUED TO OCCUR. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES OR ANGULATION/KINK NOTED IN THE DELIVERY SYSTEM. THE OCCLUDER WAS REPLACED WITH A NEW 9MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520169 ↗
• MalfunctionMay 9, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, AN 8MM AMPLATZER ATRIAL SEPTAL DEFECT (ASD) OCCLUDER (LOT: 8445798) WAS CHOSEN FOR IMPLANTATION UTILIZING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANT THE OCCLUDER FORMED A COBRA DEFORMATION. A REPLACEMENT 12MM AMPLATZER SEPTAL OCCLUDER (LOT: 8781856) WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO ANGULATION OR KINK IN DELIVERY SYSTEM. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279509 ↗
• MalfunctionApr 11, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM TO TREAT THE ATRIAL SEPTAL DEFECT. A 9MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. BOTH DEVICES WERE DEPLOYED INTO THE PATIENT AT THE SAME TIME. DURING IMPLANT THE 8MM OCCLUDER TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 9MM AMPLATZER SEPTAL OCCLUDER. DURING IMPLANT THE FIRST 9MM OCCLUDER TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 10MM AMPLATZER SEPTAL OCCLUDER. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED IN 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 19088633 ↗
• MalfunctionApr 3, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 8MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 9MM AMPLATZER SEPTAL OCCLUDER. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED IN THE DELIVERY SYSTEM. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. 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 19035838 ↗