Amplatzer™ Septal Occluder (REF 9-ASD-038)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00811806010267), received between Aug 27, 2018 and Mar 20, 2026 — classified as 13 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (11 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 38MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, WHILE DEPLOYMENT, IT WAS OBSERVED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE AND TOOK FORM OF COBRA DEFORMATION, THEREFORE IT HAD TO RETRIEVE 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 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 24652005 ↗
• MalfunctionFeb 13, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335067 ↗
• MalfunctionFeb 2, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240526 ↗
• InjuryNov 26, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025 A 38MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM TO TREAT AN ATRIAL SEPTAL DEFECT (ASD). THE ASD WAS MEASURED 38MM. SIZING WAS PERFORMED WITH A 34MM AMPLATZER SIZING BALLOON. THE DEVICES WERE PREPARED PER INSTRUCTIONS FOR USE (IFU). FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WERE USED DURING THE PROCEDURE. A STABILITY CHECK WAS PERFORMED. THE OCCLUDER WAS IMPLANTED. APPROXIMATELY 24 HOURS LATER ON TRANSTHORACIC ECHOCARDIOGRAM (TTE) THE OCCLUDER WAS SHOWN TO HAVE EMBOLIZED IN THE LEFT VENTRICLE. THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY FOR REMOVAL OF THE DEVICE. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659067 ↗
• InjuryOct 7, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025 A 38MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT TO TREAT AN ATRIAL SEPTAL DEFECT (ASD) USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. THE DEFECT MEASURED 32.8MM ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A STABILITY CHECK WAS PERFORMED. THE OCCLUDER WAS IMPLANTED. THE FOLLOWING DAY IT WAS NOTED THAT THE OCCLUDER EMBOLIZED TO THE RIGHT ATRIUM ON TEE. THE PATIENT WAS REFERRED TO CARDIAC SURGERY. THE OCCLUDER WAS EXPLANTED, AND THE ASD WAS SURGICALLY CLOSED. THE USER BELIEVED THE DEVICE EMBOLIZATION WAS DUE TO THE DEFECT BEING LARGE IN SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23235589 ↗
• MalfunctionSep 29, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23174917 ↗
• MalfunctionApr 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 38MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F NON-ABBOTT SHEATH. DURING IMPLANT THE OCCLUDER TOOK ON A BARBELL SHAPE. SEVERAL ATTEMPTS WERE MADE TO CONFORM THE OCCLUDER BACK TO ITS ORIGINAL SHAPE WITH PARTIALLY RE-CAPTURING AND RE-DEPLOYING THE OCCLUDER BUT WERE UNSUCCESSFUL. THERE WAS SOME INTERACTION WITH THE LEFT ATRIAL ROOF AND THE LEFT UPPER PULMONARY VEIN. THE OCCLUDER WAS REMOVED AND REPLACED WITH A NEW 38MM AMPLATZER SEPTAL OCCLUDER, WHICH WAS SUCCESSFULLY IMPLANTED. 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 21901188 ↗
• InjuryFeb 6, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 38MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN ABBOTT DELIVERY SYSTEM. THE STABILITY CHECK WAS PERFORMED AND THE OCCLUDER WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, IT WAS NOTED THAT THE OCCLUDER WAS EMBOLIZED AND FOUND IN THE RIGHT ATRIUM. THE DEVICE GOT RETRIEVED PERCUTANEOUSLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322670 ↗
• MalfunctionOct 30, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567311 ↗
• MalfunctionOct 16, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 38MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE LEFT DISC OF THE DEVICE WAS NOT FORMING THE RIGHT SHAPE. WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE DELIVERY CABLE. NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM AND INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. A 14MM AMPLATZER VASCULAR PLUG II WAS SELECTED AS A REPLACED BUT COULD NOT ADVANCE IN THE DELIVERY CABLE. NO DEVICE WAS ULTIMATELY IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463189 ↗
• MalfunctionJun 12, 2024Difficult 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 THAT ON 23 APR. 2024, A 38MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, WHILE THE DEVICE WAS BEING DEPLOYED, IT WAS NOTED THAT IT PRESENTED IN A COBRA DEFORMATION. THERE WAS INTERACTION WITH THE PATIENTS CARDIAC STRUCTURES, BUT NO ANGULATION/KINK IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED AND REPLACED WITH A 36MM AMPLATZER SEPTAL OCCLUDER TO RESOLVE THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT IS STABLE AND THERE WERE NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519302 ↗
• MalfunctionFeb 6, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 38MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A NON-ABBOTT DELIVERY SHEATH. DURING IMPLANT THE DISC OF THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT. 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 18654729 ↗
• MalfunctionFeb 2, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 38MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT ON 10 (B)(6) 2024. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW NON-ABBOTT DEVICE. 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 18636796 ↗
• InjuryNov 15, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 38MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. IT WAS NOTED POST-PROCEDURE THAT THE DEVICE HAD EMBOLIZED AND WAS LOCATED IN THE RIGHT VENTRICLE. THE DEVICE WAS SUCCESSFULLY RETRIEVED. THE PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO ADVERSE PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143025 ↗
• MalfunctionOct 3, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 38MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION INTO AN ATRIAL SEPTAL DEFECT (ASD) UTILIZING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM. AFTER POSITIONING THE RIGHT DISC OF THE OCCLUDER, THE LEFT DISC HAD A BULBOUS SHAPED DEFORMITY. IT WAS DECIDED TO RETRIEVE THE DEVICE AND REMOVE FROM ANATOMY. HOWEVER, THE LEFT DISC WOULD NOT REENTER THE SHEATH AS IT WAS IN A SMALL BALL SHAPE. AFTER SEVERAL ATTEMPTS AND "UNTWISTING" THE CABLE, THE DEVICE WAS ABLE TO ENTER THE SHEATH. WHEN REMOVING THE SHEATH, THE BLUE TIP OF THE SHEATH WAS OBSERVED TO BE FOLDED IN. OUTSIDE OF THE BODY, THE OCCLUDER HELD THE BULBOUS SHAPE. THERE WAS NO KINK OR ANGULATION IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES. THERE WAS NO REPORTED PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861422 ↗
• InjurySep 11, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE ARTICLE, "LATE EROSION OF AMPLATZER SEPTAL OCCLUDER DEVICE 9 YEARS AFTER THE IMPLANTATION. A CASE REPORT.", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 50-YEAR-OLD FEMALE WITH AN ATRIAL SEPTAL DEFECT (ASD). IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 38MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED TO OCCLUDE AN ATRIAL SEPTAL DEFECT WITH A MAXIMUM DIAMETER OF 29MM. IT WAS LATER REPORTED 9 YEARS LATER, THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH SYMPTOMS OF CARDIOGENIC SHOCK. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED A LARGE PERICARDIAL EFFUSION WITH TAMPONADE PHYSIOLOGY. A DECISION WAS MADE TO PERFORM EMERGENCY PERICARDIOCENTESIS AND 700 ML OF FLUID WAS DRAINED AND THE PATIENT WAS STABILIZED. THE PATIENT WAS LATER ADMITTED FOR SURGERY TO EXPLANT THE 38MM ASO FOR SUSPECTED CARDIAC EROSION. DURING PROCEDURE, A PERFORATION WAS DISCOVERED IN THE ROOF OF THE LEFT ATRIUM WHICH WAS SURGICALLY CLOSED. THE ASD WAS REPAIRED WITH A PERICARDIAL PATCH AFTER EXPLANT OF THE 38MM ASO. THE PATIENT STATUS WAS REPORTED AS STABLE. THE ARTICLE CONCLUDED DIAGNOSIS AND TREATMENT OF CARDIAC EROSION ARE NOT ALWAYS EASY. IT MAY OCCUR EVEN A LONG TIME AFTER THE PLACEMENT OF THE DEVICE AND I

  Patient problems: Cardiac Tamponade; Heart Failure/Congestive Heart Failure; Pericardial Effusion

  MAUDE report 17720284 ↗
• InjuryMay 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, A 38MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING THE PROCEDURE, THE DEVICE WAS IMPLANTED WITHOUT DIFFICULTY OR MULTIPLE MANIPULATIONS. AFTER THE DEVICE WAS IMPLANTED, IT WAS NOTICED THAT THE DEVICE WAS TOUCHING THE RIGHT ATRIUM. THE FOLLOWING DAY ON (B)(6) 2023, THE PATIENT PRESENTED WITH CHEST PAIN AND HYPOTENSION. IT WAS CONFIRMED THAT EROSION OF RIGHT ATRIUM NEAR THE AORTIC ROOT HAD OCCURRED. THE DEVICE WAS EMERGENTLY EXPLANTED THE SAME DAY. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Angina; Erosion; Low Blood Pressure/ Hypotension

  MAUDE report 16940184 ↗
• InjuryDec 28, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, A 38MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED WITH NO REPORTED COMPLICATIONS. THE SAME DAY, THE DEVICE EMBOLIZED INTO THE RIGHT ATRIUM (SEEN ON ECHO) AND THE OCCLUDER WAS SURGICALLY REMOVED. IT WAS REPORTED THAT THE CAUSE OF THE DEVICE EMBOLIZING WAS DUE TO BEING TOO BIG. ULTIMATELY, NO DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095173 ↗
• MalfunctionOct 28, 2021Off-Label Use; Material Deformation; Off-Label Use; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT, HOWEVER THE DEVICE WAS MIS-SIZED TOO SMALL AND REMOVED WHILE STILL ATTACHED TO THE DELIVERY CABLE. THEN, A 32MM AMPLATZER SEPTAL OCCLUDER WAS ATTEMPTED; WHICH WAS ALSO MIS-SIZED AND REMOVED WHILE STILL ATTACHED TO THE DELIVERY CABLE. IN THE PROCESS OF RE-CROSSING THE VENTRICULAR SEPTAL DEFECT (VSD), THE 12F AMPLATZER TORQVUE DELIVERY SYSTEM DEVELOPED A KINK DUE TO TORTUOUS PATIENT ANATOMY AND WAS EXCHANGED FOR A NEW 12F AMPLATZER TORQVUE DELIVERY SYSTEM. THEN, A 28MM AMPLATZER SEPTAL OCCLUDER WAS ATTEMPTED, HOWEVER THE DEVICE DEFORMED WITH A COBRA HEAD AND WAS REMOVED WHILE STILL ATTACHED TO THE DELIVERY CABLE. DURING ANOTHER ATTEMPT AT CROSSING THE VSD, AN UNKNOWN MANUFACTURER GUIDE WIRE PERFORATED THE RIGHT VENTRICLE, RESULTING IN PERICARDIAL EFFUSION AND HEMODYNAMIC INSTABILITY. THE PATIENT PASSED AWAY DUE TO PERFORATION OF THE RIGHT VENTRICLE. THE PATIENT'S DEATH IS NOT RELATED TO AN ABBOTT DEVICE, BUT A NON-ABBOTT GUIDEWIRE USED DURING THE PROCEDURE. NOT ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12714448 ↗
• InjurySep 15, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2021, A 38MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. THE PATIENT WAS EXPERIENCING NON-SUSTAINED VENTRICULAR TACHYCARDIA WAS NOTED ON CARDIAC MONITORING AND PROMPTED AN ECHOCARDIOGRAM WAS PERFORMED TO ASSESS THE DEVICE'S PLACEMENT AND STABILITY. ON (B)(6) 2021, IT WAS NOTED THAT THE DEVICE HAD EMBOLIZED INTO THE RIGHT VENTRICLE. ON (B)(6) 2021, IT WAS DECIDED TO REFER THE PATIENT FOR SURGICAL CLOSER AND THE DEVICE WAS RETRIEVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Tachycardia

  MAUDE report 12473918 ↗
• MalfunctionAug 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 38 MM AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE WAS CHOSEN FOR PROCEDURE. DURING PROCEDURE, THE DEVICE WAS DEFORMED UPON DELIVERY. THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. A REPLACEMENT DEVICE, A 34 MM ASO, WAS 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313064 ↗
• InjuryJul 8, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED A 38 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR A PROCEDURE ON (B)(6) 2021. ON THE SAME DAY, POST IMPLANT, DURING A POST PROCEDURE ECHOCARDIOGRAM (ECHO) IT WAS DETERMINED THE DEVICE HAD EMBOLIZED. THE PATIENT WAS TAKEN FOR SURGICAL REMOVAL OF THE EMBOLIZED DEVICE AND UNDERWENT A SUCCESSFUL SURGICAL CLOSURE OF THE DEFECT. ALTHOUGH THE EVENT DID CAUSE A PROLONGED HOSPITALIZATION, THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND IS RECOVERING. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body Embolism

  MAUDE report 12134805 ↗
• MalfunctionApr 7, 2021Material Deformation; Material Deformation

  RELATED MANUFACTURING REFERENCE NUMBER: 2135147-2021-00132 ON (B)(6) 2021, AFTER BALOON SIZING AT 34MM WITH LITTLE AORTIC RIM, A 38MM AMPLATZER SEPTAL OCCLUDER(LOT#5612973) WAS SELECTED FOR IMPLANT IN THE PATIENT USING AN AMPLATZER TORQVUE DELIVERY SYSTEM(LOT#7302272). DURING THE PROCEDURE THE DEVICE DEPLOYED INTO A COBRA SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR A NEW 38MM AMPLATZER SEPTAL OCCLUDER(LOT#6330319). USING THE SAME DELIVERY SYSTEM, THE 38MM DEVICE WAS DEPLOYED IN THE PATIENT, BUT WAS MISSIZED TOO LARGE. THE DEVICE AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND EXCHANGED FOR A 32MM AMPLATZER SEPTAL OCCLUDER(LOT#6140846) AND A NEW AMPLATZER TORQVUE DELIVERY SYSTEM(LOT#707244). THE DEVICE DEPLOYED IN THE PATIENT IN A COBRA SHAPE AND THE PHYSICIAN EXCHANGED THE DEVICE FOR A NEW 32MM AMPLATZER SEPTAL OCCLUDER(LOT# 5933064). USING THE SAME DELIVERY SYSTEM, THE DEVICE WAS DEPLOYED WITH GOOD RESULTS IN THE PATIENT AND WAS RELEASED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, BUT THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE WITH NO ADVERSE EVENTS. THE PATIENT IS CURRENTLY DISCHARGED AND STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632064 ↗
• MalfunctionSep 29, 2020Material Deformation; Material Deformation

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). ON (B)(6) 2020 DECIDED TO IMPLANT A 24MM AMPALTZER SEPTAL OCCLUDER. THE DEVICE ENDED UP BEING TOO SMALL FOR THE DEFECT AND THE PHYSICIAN DECIDED TO USE A 36MM. WHEN THE PHYSICIAN UNSHEATHED THE LEFT DISC THE DEVICE FORMED A COBRA SHAPE. THE PHYSICIAN THEN RE-SHEATHED THE DEVICE AND REMOVED IT FROM THE PATIENT'S BODY. THE PHYSICIAN DECIDED TO USE THE 38MM AND UNSHEATHED THE RIGHT DISC DURING THE PROCEDURE AND THE DISC FORM COBRA SHAPE. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT'S BODY AND THE PROCEDURE WAS ABORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10602839 ↗
• InjuryAug 24, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020 A 38MM AMPLATZER WAS SELECTED FOR A PROCEDURE. POST PROCEDURE THE DEVICE EMBOLIZED AND THE PHYSICIAN SURGICALLY REMOVED THE DEVICE FROM RIGHT ATRIA. THE PATIENT IS DOING STABLE.

  Patient problems: Embolism

  MAUDE report 10446023 ↗