Amplatzer™ Septal Occluder (REF 9-ASD-016)Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00811806010137), received between Jun 29, 2018 and Aug 3, 2026 — classified as 26 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (39 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 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50121965 ↗
• MalfunctionApr 3, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 16MM AMPLATZER OCCLUDER WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER DID NOT CONFORM TO ITS DESIRED SHAPE, BUT IT TOOK FORM OF COBRA DEFORMATION ON BOTH THE DISCS. THE PATIENT WAS SENT FOR SURGERY. 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 24782579 ↗
• MalfunctionMar 2, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE DELIVERY SYSTEM WAS POSITIONED IN THE MID LEFT ATRIUM TO DEPLOY THE DEVICE. AS THE LEFT DISC WAS BEING DEPLOYED, IT COBRA HEADED. THE PHYSICIAN PULLED THE DEVICE BACK IN THE DELIVERY SHEATH AND ATTEMPTED TO DEPLOY IT AGAIN AND IT CAME OUT DEFORMED AGAIN. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND PLACED A NEW 18MM AMPLATZER SEPTAL OCCLUDER IN THE PATIENT WITH NO ISSUES. THE DEFORMED DEVICE EVER 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 24483134 ↗
• MalfunctionFeb 20, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS NOTED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND EVEN AFTER MULTIPLE ATTEMPTS IT WAS NOT CONFORMING TO ITS DESIRED SHAPE AND TOOK FORM OF COBRA DEFORMATION. THE PROCEDURE WAS ABORTED; 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 24405465 ↗
• MalfunctionFeb 9, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298582 ↗
• MalfunctionJan 2, 2026Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950742 ↗
• MalfunctionDec 5, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE IMPLANTING THE OCCLUDER, IT WAS NOTED THAT THE DEVICE TRANSFORMED INTO A COBRA-LIKE DEFORMATION. THE EFORMED DEVICE WAS RELEASED FROM THE DELIVERY SYSTEM 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 AN NEW 17MM 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 23732784 ↗
• MalfunctionOct 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025 , A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, THE DELIVERY CATHETER POPPED INTO THE RIGHT ATRIUM(RA) AS THE DEVICE WAS EXPOSED AND CONCURRENTLY, THE LEFT ATRIAL DISC TOOK FORM OF COBRA DEFORMATION. THEREFORE, PHYSICIAN REMOVED THE DEFORMED DEVICE AND REWIRED THE OCCUDER TO PREPARE FOR REIMPLANTATION. DUE TO THE DEFORMATION OBSERVED IN THE INITIAL DEVICE, THE PHYSICIAN CHOSE TO USE A DIFFERENT DEVICE WITH NO DEFORMATION ISSUES. THE PROCEDURE WAS COMPLETED USING A 16MM AMPLATZER SEPTAL OCCLUDER. THERE WAS NO ANGULATION/KINK OBSERVED ON THE DELIVERY CABLE. IT WAS ALSO REPORTED THAT THERE WAS NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE AND PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295710 ↗
• InjuryOct 3, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6)2025, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ONE HOUR AFTER THE PROCEDURE, THE DEVICE WAS REPORTED TO HAVE EMBOLIZED INTO THE LEFT VENTRICLE. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL DUE TO THE AVAILABILITY OF CARDIAC SURGERY. THE DEVICE WAS SUCCESSFULLY RECAPTURED VIA A PERCUTANEOUS APPROACH. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23209225 ↗
• MalfunctionSep 29, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE FORMED A COBRA-LIKE SHAPE. THE DEVICE WAS REMOVED FROM THE LOADER, AND AN ATTEMPT WAS MADE TO RECONFIGURE IT. THE RE-PREPARED DEVICE COULD NOT BE ADVANCED THROUGH THE DELIVERY SYSTEM. A NEW 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. A SMALL RESIDUAL LEAK WAS OBSERVED IN THE SHORT ACCESS ALONG THE PATENT FORAMEN OVALE (PFO) TUNNEL IN ECHOCARDIOGRAM. THE DEVICE WAS DETERMINED TO BE MIS-SIZED AND WAS REMOVED DUE TO THE RESIDUAL LEAK. THE PROCEDURE WAS COMPLETED USING A 20MM AMPLATZER SEPTAL OCCLUDER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADVERSE EVENTS WERE REPORTED, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23175192 ↗
• MalfunctionSep 16, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, THE OCCLUDER WAS NOTED TO HAVE A COBRA DEFORMATION. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO INTERACTIONS WITH THE CARDIAC STRUCTURES DURING THE DEPLOYMENT AND NO ANGULATION/KINK WERE OBSERVED WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 14MM 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 23067029 ↗
• MalfunctionJul 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT, DEFORMATION (COBRA HEAD) WAS OBSERVED IN THE LEFT ATRIAL DISC. 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. A NEW 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532892 ↗
• MalfunctionJul 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 13F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE LEFT ATRIAL (LA) DISC WAS DEFORMED WITH A COBRA HEAD. THE DEVICE AND THE DELIVERY SHEATH WAS SWAPPED OUT. 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 13F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM AND A NEW 16MM AMPLATZER SEPTAL OCCLUDER WERE CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509801 ↗
• 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 22394871 ↗
• MalfunctionJun 12, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 16 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN UNKNOWN 8F ABBOTT DELIVERY SYSTEM. DURING IMPLANT BOTH THE LEFT AND RIGHT DISCS OF THE OCCLUDER TOOK ON COBRA SHAPES. MULTIPLE ATTEMPTS WERE MADE TO RE-DEPLOY THE OCCLUDER, HOWEVER THE COBRA SHAPES REMAINED. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND REPLACED WITH A 16MM NON-ABBOTT DEVICE. 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 ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196132 ↗
• MalfunctionApr 21, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 8F 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 15MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN AND SUCCESSFULLY IMPLANTED USING THE SAME DELIVERY SYSTEM. THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875144 ↗
• MalfunctionApr 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21744935 ↗
• MalfunctionMar 31, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, A COBRA-LIKE DEFORMATION OCCURRED ON BOTH DISC SURFACES WHILE RELEASING THE OCCLUDER WITH THE STEEL CABLE, AND IT COULD NOT BE RESTORED. THE CUSTOMER REPORTED THAT THE DEVICE¿S FLOW-BLOCKING MEMBRANE DID NOT FULLY COVER THE DEFECT, ULTIMATELY LEADING TO THE FAILURE OF THE PROCEDURE. 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 18MM 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 21731426 ↗
• MalfunctionFeb 27, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 7F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING DEVICE PREPARATION, THE OCCLUDER HAD GOOD DEPLOYMENT WHEN TESTED OUTSIDE OF THE PATIENT. THE OCCLUDER WAS THEN DELIVERED TO THE IMPLANT LOCATION, HOWEVER COBRA DEFORMATION OF THE LEFT DISC OCCURRED DURING DEPLOYMENT. THE OCCLUDER WAS RE-SHEATHED AND DEPLOYED AGAIN, HOWEVER THE DEFORMATION PERSISTED. THERE WERE NO INTERACTIONS 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 AND INSPECTED OUTSIDE OF THE PATIENT, WHERE COBRA DEFORMATION CONTINUED TO PERSIST. THE DEVICE WAS EXCHANGED FOR A NEW 16MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21479482 ↗
• MalfunctionJan 9, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING AN 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE VIA FLUOROSCOPY, THAT THE OCCLUDER EXHIBITED A COBRA DEFORMATION MULTIPLE TIMES WHEN DEPLOYED. 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 16MM AMPLATZER SEPTAL OCCLUDER MISHANDLED OR DAMAGED DURING DEVICE PREPARATION. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 16MM AMPLATZER SEPTAL OCCLUDER WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117845 ↗
• InjuryDec 20, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT IN AN ASD OF 6.1 MM X 7.5 MM WITH LEFT TO RIGHT SHUNT. DURING THE PROCEDURE, THE DEVICE WAS SUCCESSFULLY IMPLANTED. IMMEDIATELY AFTER, IT WAS NOTED THAT THE DEVICE HAD EMBOLIZED INTO THE FEMORAL AORTA. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT VIA PERCUTANEOUS RETRIEVAL. A 35MM AMPLATZER MULTIFENESTRATED SEPTAL CRIBRIFORM OCCLUDER WAS THEN IMPLANTED. THE PHYSICIAN DOESN'T BELIEVE THAT THE PATIENT EXPERIENCED ANY ADVERSE HEALTH CONSEQUENCES DUE TO THE PERFORMANCE OF THE PRODUCT. THE PHYSICIAN BELIEVES THE CAUSE OF THE EMBOLIZATION WAS DUE TO COMPLEX ANATOMY WITH A LONG, THIN AND ANEURISMATIC SEPTUM. THERE WAS AN INCREASE IN PROCEDURE TIME, BUT THE PATIENT REMAINED HEMODYNAMICALLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20989637 ↗
• MalfunctionDec 17, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN SIZE DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER WAS DEFORMED IN TO A COBRA SHAPE. 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 16MM 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 20956102 ↗
• MalfunctionSep 19, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 8F TREVISO DELIVERY SYSTEM (DS). DURING THE PROCEDURE, WHILE THE DEVICE WAS BEING DEPLOYED, THE DEVICE PRESENTED IN A COBRA DEFORMATION. THE DEVICE WASN'T IMPLANTED AND A 26MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED USING A 10F TREVISO DS. THE LARGER SIZE ALLOWED THE CLOSURE OF TWO ASDS THAT WERE PRESENT. THERE WAS NO ANGULATION OR KINK NOTED IN THE DELIVERY SYSTEM OR INTERACTIONS WITH CARDIAC STRUCTURES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257065 ↗
• MalfunctionJul 26, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 16MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE PATIENT WAS UNDER CONSCIOUS SEDATION. DURING THE PROCEDURE THE DELIVERY SYSTEM WAS ASPIRATED PRIOR TO INSERTION OF THE OCCLUDER. THE CONTINUOUS FLUSH WAS ATTACHED TO THE Y-PORT OF THE DELIVERY SYSTEM. DURING IMPLANT THE LEFT ATRIAL DISC OF THE DEVICE TOOK ON A COBRA SHAPE. DURING RE-DEPLOYMENT THE PATIENT EXPERIENCED AN ST ELEVATION, FOLLOWED BY BRADYCARDIA AND A DROP IN BLOOD PRESSURE. ADRENALIN AND ATROPINE WERE ADMINISTERED. THE PATIENT RE-STABILIZED WITHIN 5 MINUTES. THE DEVICE WAS RE-CAPTURED AND RE-DEPLOYED BUT THE COBRA SHAPE PERSISTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 17MM AMPLATZER SEPTAL OCCLUDER. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. NO LEAKS WERE OBSERVED. THE PHYSICIAN SUSPECTED AN AIR EMBOLISM CAUSED THE ST ELEVATION. NO AIR WAS VISUALIZED IN THE PATIENT, HOWEVER LOW LEFT ATRIAL PRESSURE AND ADVANCING AIR INTO THE PATIENT'S HEART ALONG WITH THE DEVICE WAS ATTRIBUTED TO THE AIR EMBOLISM. THE PATIENT STATU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841920 ↗
• MalfunctionJul 18, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE OCCLUDER 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 15MM 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 DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772934 ↗