Amplatzer™ Septal Occluder (REF 9-ASD-034)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00811806010243), received between Mar 18, 2019 and Mar 17, 2026 — classified as 2 deaths, 7 injuries, 12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. DEVICE SIZING WAS DETERMINED USING BALLOON SIZING. THE PROCEDURE WAS PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND FLUOROSCOPIC GUIDANCE. THE OCCLUDER WAS POSITIONED WITHIN THE ATRIAL SEPTAL DEFECT; HOWEVER, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO DETACH THE DEVICE FROM THE DELIVERY CABLE. AFTER THE DEVICE WAS EVENTUALLY RELEASED, IT SHIFTED FROM ITS INTENDED POSITION OFF THE SUPERIOR VENA CAVA (SVC) RIM, WHICH WAS IDENTIFIED ON TEE IMAGING. THE IMPLANTER REPORTED THAT THE SHIFT OCCURRED AT THE TIME OF RELEASE FROM THE DELIVERY CABLE, AND THIS WAS BELIEVED TO BE THE CAUSE OF THE DEVICE MIGRATION. A STABILITY CHECK WAS PERFORMED FOLLOWING DEPLOYMENT. A RESIDUAL LEAK MEASURING 1¿3 MM AROUND THE RIGHT ATRIAL DISC WAS OBSERVED DURING INTRAPROCEDURAL ASSESSMENT. THE PATIENT EXPERIENCED A RHYTHM CHANGE AND SUBSEQUENTLY DEVELOPED HEMODYNAMIC INSTABILITY WITH INTERACTION BETWEEN THE DEVICE AND THE TRICUSPID VALVE. GIVEN THE DEVICE MALPOSITION, AN ATTEMPT WAS MADE TO REPOSITION THE OCCLUDER BY SNARING THE PIN ON THE RIGHT ATRIAL DISC. DURING THIS

  Patient problems: Arrhythmia

  MAUDE report 24618007 ↗
• MalfunctionFeb 11, 2026Difficult to Fold, Unfold or Collapse

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317746 ↗
• InjuryDec 17, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 34 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F DELIVERY SYSTEM IN A 37-YEAR-OLD PATIENT DIAGNOSED WITH ATRIAL SEPTAL DEFECT (ASD). THE DIAGNOSIS WAS CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY, WHICH MEASURED THE DEFECT AT APPROXIMATELY 22 MM WITH ADEQUATE RIMS. DEVICE SIZING WAS DETERMINED USING BALLOON SIZING IN COMBINATION WITH ECHOCARDIOGRAPHIC IMAGING AND TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) WAS USED DURING THE PROCEDURE. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM FOR PERCUTANEOUS CLOSURE UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE, MEASUREMENT BY ECHOCARDIOGRAPHER WAS NOTED AT 28 MM. STABILITY OF THE DEVICE WAS CONFIRMED USING THE VALSALVA MANEUVER, AND PROPER POSITIONING OF THE RIMS WITHIN THE DEVICE WAS ACHIEVED. THE DEVICE WAS THEN SUCCESSFULLY RELEASED. AT THE 48-HOUR POSTOPERATIVE FOLLOW-UP, ON (B)(6) 2025, A TRANSTHORACIC ECHOCARDIOGRAM IDENTIFIED MIGRATION OF THE DEVICE INTO THE RIGHT ATRIUM. THE DEVICE HAD COMPLETELY DISLODGED FROM THE IMPLANT SITE. THE IMPLANTER INDICATED THAT THE POSTERIOR RIM WAS POSSIBLY FLOPPIER. NO RHYTHM CHANGES WERE OBSERVED DURING THE PROCEDURE, AND NO LEAK WAS DETECTED AROU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824988 ↗
• InjuryDec 15, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 32MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM. TRANSESOPHAGEAL ECHOCARDIOGRAPHY MEASURED THE DEFECT AT 28 MM, AND STOP-FLOW BALLOON SIZING MEASURED 30 MM, WITH ADEQUATE RIMS EXCEPT FOR AN ANTERIOR DEFECT WHERE THE AORTIC RIM MEASURED 5 MM. THE INITIAL DEVICE 32MM AMPLATZER SEPTAL OCCLUDER WAS DEPLOYED BUT RESIDUAL FLOW PERSISTED, PROMPTING EXCHANGE FOR A LARGER 34MM AMPLATZER SEPTAL OCCLUDER , WHICH WAS DELIVERED AFTER SEVERAL ATTEMPTS AND APPEARED STABLE ON IMAGING IN MULTIPLE VIEWS. IT WAS NOTED THAT IT TOOK SOME MANUPULATION TO CATCH TH EAORTIC RIM TO PSOITION THE DEVICE. THE DEVICE WAS RELEASED FOLLOWING CONFIRMATION OF POSITION AND FLOW ELIMINATION. LATER THAT DAY, EMBOLIZATION OF THE DEVICE WAS REPORTED, THE DEVICE HAD COMPLETELY DISLODGED FROM ITS IMPLANT SITE AND TRAVEK TO THE LEFT ATRIUM IN THE PATIENT'S ANATOMY. THE PATIENT UNDERWENT SURGICAL CLOSURE WITH REMOVAL OF THE OCCLUDER. THE PHYSICIAN BELIEVED THE CAUSE OF THE EMBOLIZATION WAS ANEURYSMAL SEPTUM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809473 ↗
• MalfunctionSep 12, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F NON-ABBOTT SHEATH. DURING THE DEPLOYMENT OF THE DEVICE, THE PHYSICIAN NOTICED THAT THE DESIRED SHAPE WAS NOT TAKEN BY THE DEVICE. THE RIGHT DISC OF THE DEVICE WAS GETTING DEFORMED. IT AS NOTED AS COBRA DEFORMATION. AFTER MULTIPLE ATTEMPTS THE ISSUE PERSISTED, THEREFORE THE DEVICE WAS REMOVED. THE OCCLUDER WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WERE NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WERE OBSERVED IN THE DELIVERY SYSTEM. IT IS REPORTED THAT THE PATIENT WAS HEMODYNAMICALLY STABLE WITH NO ADVERSE CONSEQUENCES AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043171 ↗
• MalfunctionAug 8, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F SHEATH. DURING DEPLOYMENT, IT WAS NOTED THAT THE LEFT DISC OF THE DEVICE WAS NOT TAKING ITS PROPER SHAPE. THE PHYSICIAN TRIED TO RECAPTURE AND REDEPLOY BUT THE ISSUE PERSISTS. 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 PROCEDURE GOT TERMINATED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749463 ↗
• MalfunctionJun 6, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2025 A 34MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING IMPLANT THE OCCLUDER TOOK ON A COBRA SHAPE. THE OCCLUDER WAS RE-SHEATHED AND DEPLOYED AGAIN; HOWEVER, THE COBRA SHAPE REMAINED. THE OCCLUDER WAS NOT RELEASED FROM THE DELIVERY CABLE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND RE-DEPLOYED OUTSIDE, BUT THE COBRA SHAPE STILL REMAINED. THE OCCLUDER WAS REPLACED WITH A NEW 34MM 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 ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161821 ↗
• MalfunctionApr 28, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT O (B)(6) 2025, A 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 6F MULLINS DELIVERY SHEATH. DURING DEPLOYMENT THE OCCLUDER DEFORMED IN TO A COBRA SHAPE SO IT WAS REMOVED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES OR ANGULATION/KINK IN THE DELIVERY SYSTEM. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919234 ↗
• MalfunctionJan 9, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2024, A 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING DEVICE PREPARATION, THE PHYSICIAN NOTICED THAT A PART WAS MISSING AT THE TIP OF THE LOADER. DURING PROCEDURE, WHEN THE DEVICE WAS PARTIALLY DEPLOYED (LEFT DISC EXPOSED) AND FULLY RETRACTED INTO THE DELIVERY SYSTEM, A THREAD WAS SHOWING BETWEEN THE TIP OF THE DELIVERY SHEATH AND THE LEFT DISK DURING DEPLOYMENT. THEY STOPPED MANIPULATING/DEPLOYING THE DEVICE WHEN THE THREAD WAS NOTED. AFTER RECAPTURING THE DEVICE, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS TAKEN AND NOTICED A 7.5MM X 4MM THROMBUS WAS NOTED IN THE LEFT ATRIAL APPENDAGE (LAA). THE SHAPE OF THE THROMBUS WAS CIRCULAR AND THE ACT WERE BETWEEN 220S AND 240S THROUGHOUT THE PROCEDURE. AT END OF THE PROCEDURE THE ACT WAS MEASURED AGAIN AND IT WAS 238, TOTAL OF 5500 UNITS OF HEPARIN WAS GIVEN DURING THE PROCEDURE. THE PHYSICIAN MENTIONED THE SHEATH WAS IN THE PATIENT FOR A SIGNIFICANT PERIOD OF TIME. THE PATIENT WILL REMAIN HOSPITALIZED FOR TWO DAYS UNDER OBSERVATION AND WILL TAKE ANTICOAGULANTS FOR THE NEXT 6 MONTHS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21120718 ↗
• MalfunctionMay 13, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 34MM AMPLATZER SEPTAL OCCLUDER (LOT: 9206144) WAS CHOSEN FOR IMPLANTATION UTILIZING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING IMPLANTATION, THE DEVICE DEFORMED INTO A COBRA SHAPE. A REPLACEMENT 34MM AMPLATZER SEPTAL OCCLUDER (UNKNOWN LOT) AND REPLACEMENT 12F AMPLATZER TREVISIO DELIVERY SYSTEM (UNKNOWN LOT) WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298329 ↗
• MalfunctionFeb 28, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A NON-ABBOTT 14F ( 4.67MM INNER DIAMETER) DELIVERY SHEATH. DURING DEPLOYMENT THE DEVICE DEFORMED INTO A COBRA SHAPE. THERE WAS NO KINK OR BEND IN THE DELIVERY SYSTEM AND NO INTERACTION WITH CARDIAC STRUCTURES. THE DEVICE WAS REMOVED. NO REPLACEMENT WAS IMPLANTED. PATIENT WAS REPORTED TO BE STABLE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798998 ↗
• MalfunctionDec 12, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. DURING DEPLOYMENT, THE DEVICE WAS OBSERVED TO DEFORM IN A COBRA-LIKE SHAPE. A REPLACEMENT 36MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311438 ↗
• DeathSep 15, 2023Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER WAS CHOSEN FOR IMPLANT. THE PATIENT HAD PREVIOUSLY PRESENTED TO THE HOSPITAL WITH A MYOCARDIAL INFARCTION ON (B)(6) 2023, AND THE DEVICE WAS CHOSEN TO EMERGENTLY CLOSE A POST-INFARCT VENTRICULAR SEPTAL DEFECT (VSD). THE DIMENSIONS OF THE DEFECT WERE APPROXIMATELY 20MM X 28MM, AND THE SIZING OF THE DEVICE WAS DETERMINED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY. PRIOR TO PROCEDURE ON (B)(6) 2023, THE PATIENT PRESENTED WITH A LARGE VENTRICULAR SEPTAL RUPTURE AND WAS IN PROFOUND CARDIOGENIC SHOCK REQUIRING IMPELLA DEVICE SUPPORT, HYPOTENSION, ACUTE PULMONARY EDEMA, AND RENAL FAILURE. THE VSD OCCLUDER WAS INITIALLY PLACED BUT WAS TOO SMALL FOR THE DEFECT, SO IT WAS REMOVED PRIOR TO RELEASE FROM DELIVERY CABLE. THE DEVICE WAS REPLACED WITH A 34MM AMPLATZER SEPTAL OCCLUDER AND THEN SUCCESSFULLY IMPLANTED TO CLOSE THE VSD WITH A SMALL RESIDUAL SHUNT LEFT. THE PHYSICIAN WAS AWARE THAT THIS WAS OFF-LABEL USE TO IMPLANT AN ASO DEVICE INTO A VSD, BUT THE DECISION WAS MADE TO USE AN ASO DEVICE SINCE THERE WAS NOT A LARGER VSD DEVICE AVAILABLE. THE PATIENT WAS RETURNED TO THE CARDIAC INTENSIVE CARE UNIT (ICU)

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 17755719 ↗
• MalfunctionJun 12, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023 A 34MM AMPLATZER SEPTAL OCCLUDER (8090960) WAS ATTEMPTED TO BE IMPLANTED INTO AN ATRIAL SEPTAL DEFECT UTILIZING A 12F TORQVUE DELIVERY SYSTEM (LOT: 8541131). DURING DEPLOYMENT, THE LEFT ATRIAL DISC DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS RECAPTURED AND REDEPLOYED BUT THE COBRA DEFORMATION PERSISTED. A REPLACEMENT 36MM AMPLATZER SEPTAL OCCLUDER (LOT: 7955631) WAS THEN IMPLANTED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STABLE. THERE WAS NO REPORTED INTERACTION WITH CARDIAC STRUCTURES AND NO ANGULATIONS OR KINKS IN THE DELIVERY SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17110918 ↗
• InjuryDec 22, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. THE DEVICE WAS SIZED TO BE 30-31MM THROUGH TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE). THE DEVICE WAS DEPLOYED IN AN ABSENT AORTIC RING AND SMALL ATRIOVENTRICULAR RING. THE DEVICE DEPLOYED WELL AND WAS PLACED WELL IN THE DEFECT, AND THE PROCEDURE WAS CONCLUDED. AFTER SIX HOURS, IT WAS SEEN VIA TRANSTHORACIC ECHOCARDIOGRAM (TTE) THAT THE DEVICE EMBOLIZED TO THE LEFT ATRIUM. THE PATIENT WAS SENT FOR EMERGENCY OPEN HEART SURGERY TO EXPLANT THE DEVICE. ON THE SAME DAY, (B)(6) 2022, THE DEVICE WAS EXPLANTED SUCCESSFULLY. THE PATIENT WAS REPORTED AS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16037687 ↗
• MalfunctionAug 17, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 34MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022 USING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE PROCEDURE, ADVANCEMENT DIFFICULTY WAS OBSERVED. UPON DEPLOYMENT FROM THE DELIVERY SYSTEM, THE OCCLUDER DEFORMED WITH A COBRA SHAPE. THE DEVICE WAS RE-SHEATHED AND RE-DEPLOYED, HOWEVER THE ISSUE PERSISTED. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND THE PATIENT DID NOT HAVE A TORTUOUS ANATOMY. THE OCCLUDER WAS REMOVED AND A NEW 30MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED USING A NEW 10F AMPLATZER DELIVERY SYSTEM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242279 ↗
• InjuryJul 27, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 34MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. DEVICE WAS SIZED USING A SIZING BALLOON AND ECHOCARDIOGRAPHY. ON (B)(6) 2022, POST-PROCEDURE DAY 2, THE DEVICE EMBOLIZED INTO THE RIGHT ATRIUM AND WAS SNARED. IT IS UNKNOWN OF A DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE IMPLANT AND RETRIEVAL PROCEDURE. THERE WAS NOT A CLINICALLY SIGNIFICANT DELAY OR EXTENDED BYPASS TIME IN THE PROCEDURE DUE TO THIS EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15116935 ↗
• MalfunctionApr 27, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 34MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER DELIVERY SYSTEM. DURING PROCEDURE, THE DEVICE WAS DEPLOYED BUT WAS NOT TAKING THE DESIRED SHAPE AND APPEARED TO LOOK LIKE A COBRA HEAD. THE DEVICE WAS RETRIEVED BACK INTO THE DELIVERY SYSTEM. THERE WAS NO ANGULATION IN THE DELIVERY SYSTEM. A 32MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED INSTEAD. 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 14216694 ↗
• DeathDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A POST-INFARCT VENTRICULAR SEPTAL DEFECT CLOSURE (VSD). AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A LARGE ANEURYSM IN THE VENTRICLE, NEAR THE VSD. INITIALLY A 24MM VSD WAS SELECTED BUT DEEMED TOO SMALL, SO A 34MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED. DURING DEPLOYMENT, THE PATIENT BECAME HYPOTENSIVE AND WENT INTO CARDIAC ARREST. AN ECHOCARDIOGRAM REVEALED A CARDIAC EFFUSION AND RESUSCITATION EFFORTS WERE UNDERTAKEN FOR 45 MINUTES WHEN THE PATIENT WAS PRONOUNCED DEAD. THE ANEURYSM HAD RUPTURED LEADING TO THE EFFUSION.

  Patient problems: Aneurysm; Death; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 9444333 ↗
• InjuryApr 3, 2019Migration; Migration

  ON (B)(6) 2018, A 34MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. THREE MONTHS FOLLOWING THE IMPLANT, THE PATIENT PRESENTED WITH CHEST PAIN. A TOE WAS PERFORMED AND REVEALED THE DEVICE HAD MOVED POSTERIORLY BUT WAS NOT COMPLETELY DISLODGED. THE DEVICE WAS EXPLANTED AND A SURGICAL PATCH WAS PLACED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND WAS STABLE POST-OPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480062 ↗
• InjuryMar 18, 2019Material Deformation; Material Deformation

  ON (B)(6) 2018, A PATIENT PRESENTED WITH AN ATRIAL SEPTAL DEFECT (ASD) WITH AN ABSENCE OF AN ANTERIOR AORTIC RIM. AFTER SIZING THE DEFECT, A 32MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS SELECTED FOR IMPLANT. THE DEVICE WAS INSERTED AND POSITIONED, BUT PULLED THROUGH THE DEFECT AND WAS DEEMED TOO SMALL. THE DEVICE WAS REPLACED WITH A 34MM ASO. BOTH THE LEFT ATRIAL DISC AND RIGHT ATRIAL DISC WERE DEPLOYED, BUT THE ICE IMAGES REVEALED THE ANTERIOR MARGIN OF THE DEVICE ADJACENT TO THE AORTIC VALVE DID NOT APPEAR FULLY EXPANDED. A PUSH-PULL TEST WAS PERFORMED AND THE DEVICE PULLED THROUGH THE DEFECT. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AND OBTAIN CARDIAC SURGERY CONSULT DUE TO THE RISK OF EROSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428649 ↗