Amplatzer™ Septal Occluder (REF 9-ASD-012)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00811806010090), received between May 30, 2019 and Sep 11, 2026 — classified as 1 death, 12 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Difficult to Fold, Unfold or Collapse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733439 ↗
• InjuryFeb 23, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. PRE-PROCEDURAL IMAGING, INCLUDING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE), REPORTEDLY MEASURED THE ATRIAL SEPTAL DEFECT (ASD) BETWEEN 0.94 CM AND 1.03 CM IN VARIOUS VIEWS. BASED ON THESE MEASUREMENTS, THE CLINICAL TEAM ELECTED NOT TO BALLOON-SIZE THE DEFECT AND PROCEEDED WITH IMPLANTATION OF THE 12 MM DEVICE. THE DEVICE WAS REPORTED TO HAVE BEEN DEPLOYED WITHOUT COMPLICATIONS. A SATISFACTORY PUSH/PULL TEST WAS PERFORMED, AND NO RESIDUAL COLOR FLOW ACROSS THE DEVICE WAS OBSERVED. IT WAS ALSO REPORTED THAT THE PATIENT DID NOT EXPERIENCE A RHYTHM CHANGE DURING THE PROCEDURE, NO LEAK WAS DETECTED AROUND THE DEVICE LOBE, AND NO DIFFICULTY WITH IMPLANTATION OCCURRED, WITH ONLY ONE DEPLOYMENT PERFORMED WITHOUT RECAPTURE OR REPOSITIONING. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH BILATERAL LEG WEAKNESS. A COMPUTED TOMOGRAPHY (CT) SCAN REPORTEDLY REVEALED THAT THE ASD OCCLUDER HAD COMPLETELY DISLODGED FROM THE IMPLANT SITE AND EMBOLIZED TO THE ABDOMINAL AORTA. THE IMPLANTER REPORTEDLY BELIEVED THE C

  Patient problems: Movement Disorder

  MAUDE report 24422855 ↗
• MalfunctionFeb 10, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 8F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, AFTER DEVICE DEPLOYMENT, THE POSITIONING WAS DETERMINED TO BE INADEQUATE. THE DEVICE WAS SUBSEQUENTLY RECAPTURED AND REMOVED. UPON REMOVAL, THE LEFT DISC OF THE OCCLUDER WAS OBSERVED TO BE DEFORMED WHEN RE-EXPRESSED. THE DISC APPEARED BENT, INVOLVING APPROXIMATELY ONE-QUARTER (1/4) OF THE DISC. NO ANGULATION OR KINK WAS NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS THEN COMPLETED USING A NEW 12 MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310288 ↗
• MalfunctionNov 11, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN 10 F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYING THE LEFT ATRIAL DISC, IT WAS NOTED THAT THE OCCLUDER TOOK FORM OF A COBRA DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WERE INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A 13MM 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 23528483 ↗
• InjurySep 9, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE SIZE OF THE DEFECT WAS 10MM AND THE SIZING OF THE DEVICE WAS DETERMINED BY 18MM SIZING BALLOON. THE OCCLUDER WAS IMPLANTED AND A TUG TEST WAS PERFORMED. ON (B)(6) 2025, THE PATIENT HAD CHEST PAIN AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED THE OCCLUDER WAS EMBOLIZED INTO THE AORTA AND THE PATIENT UNDERWENT A SURGERY. THE PHYSICIAN MENTIONED THE CAUSE OF EMBOLIZATION WAS THE SEPTUM WAS REALLY THIN, SO PROBABLY NOT ENOUGH STABILITY. THE PATIENT WAS REPORTED STABLE AND DISCHARGED, SEPTUM WAS CLOSED DURING SURGERY.

  Patient problems: Angina

  MAUDE report 23006141 ↗
• MalfunctionAug 29, 2025Difficult to Fold, Unfold or Collapse; Off-Label Use; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2025, A 12MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS CHOSEN FOR IMPLANTATION INTO A PSEUDOANEURYSM NECK PRESENT ON THE OUTSIDE WALL OF THE LEFT VENTRICLE. A GREATER THAN 80CM DELIVERY SHEATH WAS REQUIRED TO REACH THE DEFECT, SO A DELIVERY CABLE FROM AN AMPLATZER TREVISIO WAS USED WITH A NON-ABBOTT TERUMO SHEATH. THE SHEATH WAS ADVANCED TO THE DEFECT. ONCE THE ASO EXITED THE TIP OF THE SHEATH, IT DEFORMED INTO A COBRA SHAPE. THE ASO WAS REMOVED AND THE DEFORMATION WAS MASSAGED OUT. THE ASO WAS RE-LOADED WITH TENSION AND ATTEMPTED TO BE DEPLOYED AGAIN BUT DEFORMED INTO COBRA SHAPE ONCE MORE. IT WAS THOUGHT PAPILLARY STRANDS MAY HAVE PREVENTED A NORMAL DEPLOYMENT OR INTERACTION WITH THE NON-ABBOTT SHEATH. A 12MM AMPLATZER VENTRICULAR SEPTAL DEFECT OCCLUDER (VSD) WAS THEN CHOSEN FOR IMPLANTATION UTILIZING THE SAME NON-ABBOTT 7F DELIVERY SHEATH. THE VSD WAS HARD TO ADVANCE THROUGH THE SHEATH, SO THE SHEATH WAS EXCHANGED FOR A NON-ABBOTT 7F SHUTTLE SHEATH. THE 12MM VSD WAS DEPLOYED BUT WAS DEFORMED (ELONGATED AND BULBOUS) POSSIBLY DUE TO PAPILLARY MUSCLE AGAIN. 12MM VSD REMOVED AND EXCHANGED FOR 10MM VSD WITH THE SAME DELIVERY SYSTEM. THE 10MM VSD WAS DEPLOYED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925932 ↗
• MalfunctionAug 15, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 23 JULY 2025, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE HAD A COBRA DEFORMATION WHEN EXPANDING INSIDE THE BODY. THE DEFORMED OCCLUDER WAS RETRIEVED OUTSIDE THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE INSIDE THE PATIENT. THERE WAS NO CONTACTS OCCURRED WITH INTRACARDIAC TISSUE DURING THE OCCLUDER DEPLOYMENT AND THERE WERE NO BENDS OR KINKS BEEN OBSERVED IN THE DELIVERY SHEATH. THE PROCEDURE WAS CANCELLED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATEIT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816137 ↗
• InjuryJul 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  N/A.

  Patient problems: Fatigue; Pain

  MAUDE report 22592026 ↗
• MalfunctionDec 4, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 12MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 12MM AMPLATZER SEPTAL OCCLUDER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. 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 20844553 ↗
• InjuryOct 25, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT (B)(6) 2024, A 12MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE DIMENSIONS OF THE DEFECT WERE 8MM AND WAS DETERMINED BY TEE. ON (B)(6) . 2024, THE DEVICE WAS FOUND TO HAVE COMPLETELY EMBOLIZED INTO THE AORTA AND NEEDED TO BE BE EXPLANTED. ON (B)(6) 2024, THE DEVICE WAS SUCCESSFULLY EXPLANTED PERCUTANEOUSLY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534864 ↗
• InjuryJul 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2013, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR ATRIAL SEPTAL DEFECT (ASD) USING A 7F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE 850MG OF CEFAZOLIN AND 15000 UNITS OF HEPARIN WAS ADMINISTRATED. THE DEVICE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2024, THE PATIENT WAS FOUND DOWN AND BLUE AT HOME, HE REGAINED CONSCIOUSNESS BUT VERY HYPOTENSIVE. A LARGE PERICARDIAL EFFUSION WITH TAMPONADE WAS NOTED. THE PATIENT WAS IN THE PEDIATRIC INTENSIVE CARE UNIT ON PRESSORS AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WELL TOLERATED WITH THE PROCEDURE AND HEART RATE CAME DOWN FORM 120S TO 70S AND BLOOD PRESSURE INCREASED FROM 80S TO170S. THE PRESSORS WERE RAPIDLY WEANED. ON (B)(6) 2014, THE PATIENT PRESENTED IN CARDIOGENIC SHOCK WITH A PERICARDIAL EFFUSION WHICH WAS DRAINED. THE BLOOD WORK WAS NORMAL BUT THERE WAS A SUSCEPTION OF A ASD DEVICE EROSION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, DEVICE EROSION WAS CONFIRMED AND THEY DECIDED TO REMOVE THE DEVICE AND CLOSE THE ASD SURGICALLY. THE DEVICE WAS REMOVED VIA TRANSCATHETER SNARE. AFTER THE DEVICE REMOVAL THE RENDERED TISSUE QUITE FRIABLE. THE LEFT ATRIUM WAS REPAIRED SURGICALLY AND ASD WA

  Patient problems: Cardiac Tamponade; Erosion; Low Blood Pressure/ Hypotension; Pericardial Effusion; Shock; Syncope/Fainting

  MAUDE report 19697674 ↗
• InjuryJun 19, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A 6MM ATRIAL SEPTAL DEFECT (ASD) USING A 8F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEVICE WAS SUCCESSFULLY IMPLANTED. LESS THAN FIVE MINUTES AFTER THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE WAS EMBOLIZED AND MOVED TOWARDS THE AORTA. THE PHYSICIAN MENTIONED THE CAUSE OF EMBOLIZATION WAS THE ANATOMY OF PATIENT. THE DEVICE WAS REMOVED VIA TRANSCATHETER SNARE. THE PHYSICIAN NOTED THAT THERE WAS A RELATIVELY SMALL ASD ACCOMPANIED BY A PATENT FORAMEN OVALE (PFO) AND THERE WAS INSUFFICIENT EDGES, SO IT WAS DECIDED TO SEND THE PATIENT TO SURGERY FOR CLOSURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19569849 ↗
• InjuryApr 8, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE SIZING OF THE WAS DEFECT WAS 11MM MEASURED BY ECHOCARDIOGRAM. DURING PROCEDURE, THE DEVICE WAS IMPLANTED AFTER ONE RECAPTURE. COUPLE OF MINUTES AFTER THE PROCEDURE, THE DEVICE WAS MIGRATED DUE TO BEING TOO SMALL. THERE WAS NO ALLEGATION AGAINST THE SIZING OF THE DEVICE. THE DEVICE WAS REMOVED VIA TRANSCATHETER SNARE. A NEW 14MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068057 ↗
• MalfunctionOct 10, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, IT WAS NOTED THAT THE LEFT DISC FAILED TO FULLY OPEN AND REMAINED IN A DROPPING STATE WHILE RELEASING THE OCCLUDER USING STEEL CABLES. THE DEVICE HAD A BULBOUS DEFORMATION AND THE SURGERY WAS ABORTED. 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 17905283 ↗
• InjurySep 1, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, THE SIZING OF THE DEVICE WAS DETERMINED BY BALLOON SIZING, WHEN THE 12MM OCCLUDER WAS RELEASED, THE DEVICE WAS COMPLETELY DISLODGE FROM THE IMPLANT SITE AND THE DEVICE WAS SAFELY SNARED OUT. A NEW 18MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. BUT THE 18MM OCCLUDER WAS TOO SMALL AND GOT RECAPTURED AND REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE AND SWITCHED TO A NEW 22MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672642 ↗
• MalfunctionMay 31, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEPLOYMENT OF THE LEFT ATRIAL DISC, IT WAS NOTICED THE DEVICE HAD A BULBOUS DEFORMATION. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THE DEVICE WOULD NOT RETURN TO THE ORIGINAL PROPER SHAPE AND A DECISION WAS MADE TO REPLACE THE DEVICE WITH A NEW 12MM AMPLATZER SEPTAL OCCLUDER. 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 REPLACEMENT 12MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035453 ↗
• MalfunctionMay 23, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT ON A DEFECT WITH A SIZE OF 12-14MM USING A 7F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. BUT THE 12MM AMPLATZER SEPTAL OCCLUDER HAD TOO LITTLE COMPRESSION WITHIN THE SEPTUM DEFECT AND THE DEVICE DEPLOYED IN A COBRA DEFORMATION, THUS WASN'T IMPLANTED. A 14MM AMPLATZER SEPTAL OCCLUDERS WAS THEN ATTEMPTED BUT IT ALSO DEPLOYED IN A COBRA DEFORMATION. THE DEFORMED DEVICES 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 DECISION WAS MADE TO CLOSE THE DEFECT SURGICALLY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE COBRA CONFIGURATION ON BOTH OCCLUDERS. THERE NO PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981973 ↗
• MalfunctionNov 24, 2021Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 12 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR PROCEDURE, ALONG WITH A 9 F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING PROCEDURE, IT WAS FOUND THAT THE DEVICE DEPLOYED AS A COBRA DEFORMATION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN ATTEMPTED TO SOFTEN THE DEVICE BEFORE ATTEMPTING TO DEPLOY IT A SECOND TIME. HOWEVER, THE PROBLEM PERSISTED, SO A 20 MM AMPLATZER SEPTAL OCCLUDER WAS USED INSTEAD TO SUCCESSFULLY CLOSE THE DEFECT. IT WAS ALSO MENTIONED THAT THERE WAS AN IMPROPER SHAPE OF THE DEVICE THAT HAD BEEN OBSERVED AFTER THE DEVICE WAS TAKEN OUT OF THE BOX. 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 12870924 ↗
• MalfunctionOct 4, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 12 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, THE DEVICE WAS FOUND TO HAVE DEPLOYED IN A COBRA DEFORMATION. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572140 ↗
• MalfunctionMar 19, 2021Material Deformation; Material Deformation

  ON (B)(6), 2021, A 12MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR ASD PROCEDURE. HOWEVER UPON IMPLANTING THE DEVICE, IT HAD PRESENTED IN A "COBRA SHAPE" ON THE ANGIOGRAPHY WHILE DEPLOYING OUT OF THE TREVISIO DELIVERY SYSTEM. THE DEVICE REMOVED AND EXCHANGED WITH ANOTHER DEVICE OF THE SAME SIZE WAS CHOSEN AND NO ADVERSE EFFECT WAS SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11532263 ↗
• MalfunctionMar 7, 2021Material Deformation; Material Deformation

  ON (B)(6), 2021, A 12MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT IN THE PATIENT USING AN AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE THE DEVICE WAS UNABLE TO BE DEPLOYED. THE DEVICE SHOWED A COBRA SHAPE AND NOT THE USUAL OCCLUDER SHAPE. THE DEVICE WAS EXCHANGED FOR A 11MM AMPLATZER SEPTAL OCCLUDER, WHICH WORKED WELL. 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 11429507 ↗
• MalfunctionFeb 19, 2021Material Deformation; Material Deformation

  ON (B)(6) 2021, A 12MM AMPLATZER SEPTAL OCCLUDER(ASO) WAS SELECTED FOR IMPLANT. HOWEVER, THE ASO DEFORMED INTO A COBRA HEAD SHAPE AND COULD NOT BE DEPLOYED NORMALLY WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE ASO IN THE PATIENT'S ATRIUM. THE ASO WAS REMOVED FROM THE PATIENT ONCE AND THE PHYSICIAN ATTEMPTED TO RESTORE THE SHAPE BY HAND, BUT THE ASO COULD NOT BE RESHAPED FROM THE COBRA HEAD SHAPE ALTHOUGH SEVERAL ATTEMPTS WERE MADE. THE PHYSICIAN DECIDED IT WAS IMPOSSIBLE TO RESTORE THE SHAPE OF THE ASO. THE ASO WAS REPLACED WITH ANOTHER SAME-SIZED, SAME LOT ASO AND THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348546 ↗
• MalfunctionNov 16, 2020Off-Label Use; Material Deformation; Off-Label Use; Material Deformation

  AN 12MM AMPLATZER SEPTAL OCCLUDER DEVICE WAS SELECTED FOR VSD IMPLANT. THE USER TRIED A 12MM AMPLATZER SEPTAL OCCLUDER (LOT NO: 6240039),AND IT FORMED A SHAPE OF A COBRA AND WOULDN¿T SIT APPROPRIATELY. WE DECIDED WE WOULD TRY A 14MM AMPLATZER SEPTAL OCCLUDER(LOT NO: 7266691), THAT TOO ALSO FORMED A SHAPE OF A COBRA, BUT IN THIS CASE AFTER A COUPLE OF TRIES IT WOULDN¿T GO BACK TO ORIGINALLY SHAPE AS GOOD AS IT SHOULD HAVE, THE SAME THING HAPPENED WITH 13MM AMPLATZER SEPTAL OCCLUDER (LOT NO: 6791191). IT WAS DECIDED TO TRY A MUSCULAR VSD, THEREFORE WE CLOSED THE SECOND HOLE WITH AN AVP2. THE PATIENT WASN¿T HARMED AT DURING PROCEDURE. THE CASE JUST TOOK A LITTLE LONGER THAN HOPED. ADDITIONAL REPORTS FOR 9-ASD-014 (MDR-2020-48416), 9-ASD-013 (MDR-2020-48435).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10842853 ↗
• InjuryNov 11, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020 A 12 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR USE. THE 12 MM ASO WAS RELEASED FROM THE DELIVERY CABLE AND DEPLOYED AT THE DEFECT AFTER PERFORMING WIGGLE MANEUVER TO CONFIRM THE ASO STABILITY. RIGHT AFTER THE ASO RELEASED, THE ASO CAME OFF FROM THE DEFECT AND MIGRATED INTO THE DESCENDING AORTA. ALTHOUGH THE ASO WAS ATTEMPTED TO BE RETRIEVED VIA PERCUTANEOUSLY ONCE, IT DID NOT SUCCEED. SO THE ASO WAS SURGICALLY RETRIEVED IN THE END. THE PATIENT WAS REPORTED TO BE RECOVERING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10822832 ↗
• DeathOct 14, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, A 12MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT, A COBRA-DEFORMATION WAS NOTED. THE DEVICE WAS PULL BACK INTO THE SHEATH AND DETACHED INTO THE SVCAND THE DEFORMATION WAS STILL NOTED. THE OCCLUDER WAS SNARED THOUGH A LARGE SHEATH. A 18MM AMPLATZER P.I. MUSCULAR VSD OCCLUDER WAS IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND WAS UNSTABLE. A FEW HOURS POST PROCEDURE THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. IT WAS REPORTED THAT THE MUSCULAR VSD OCCLUDER HAD EMBOLIZED INTO THE RIGHT VENTRICLE AND THE PATIENT EXPIRED ON (B)(6) 2020.

  Patient problems: Death

  MAUDE report 10680622 ↗