Amplatzer™ Amulet™ 9-ACP2-007-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 285 adverse event reports that list this exact device (DI 00811806013480), received between Sep 29, 2021 and Aug 25, 2026 — classified as 29 deaths, 230 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (60 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 285 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 22mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a 14F Torquve Delivery System. Prior to procedure, there was trace effusion present. The left atrial pressure at time of procedure was 13mm Hg. During procedure, there were multiple manipulations and the device got caught on tissue a few times. The Amulet was implanted. Post procedure less than 48hrs, the patient had a large effusion and a pericardiocentesis was performed.

  Patient problems: Pericardial Effusion

  MAUDE report 50437775 ↗
• InjuryAug 24, 2026Migration or Expulsion of Device

  It was reported that on an Unknown date, a 22mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. On (b)(6) 2026, the patient came in for their 45 day post-implant transesophageal echocardiogram (TEE). The physician found that the device has shifted and is at risk of embolizing. They need to explant the device and they are currently working on scheduling an explant date. There were no negative symptoms presented in the patient. On an Unknown date, the device was extracted from the patient. The patient is doing well, no reported issues during extraction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420795 ↗
• InjuryAug 17, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026 a 22mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant. The device was implanted. On (b)(6) 2026 the patient presented with chest pain. Transthoracic echocardiography (TTE) identified a pulmonary artery injury (PAI). The PAI was surgically repaired. The patient status was stable.

  Patient problems: Perforation

  MAUDE report 50281728 ↗
• MalfunctionAug 5, 2026Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50144301 ↗
• InjuryJul 29, 2026Patient-Device Incompatibility

  It was reported on 29 June 2026 a 22 mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using a 12F Amplatzer Amulet delivery sheath for a left atrial appendage (LAA) closure. During the procedure, the left atrial pressure was above 12 mmHg. The activating clotting factor (ACT) was 339 seconds and Heparin was administered. The heart rhythm was atrial fibrillation. Transseptal puncture was made at the inferior and mid location. Protamine 30 cc was administered. The device was implanted. On (b)(6) 2026, the patient experienced chest pain and went into cardiac arrest. Cardiac tamponade was determined to be present. Injury to the pulmonary artery was noted from the stabilizing wires of the device. Surgical intervention was performed using a surgical patch on the pulmonary artery to resolve the issue. The patient status was stable.

  Patient problems: Angina; Cardiac Arrest; Cardiac Tamponade; Perforation; Pericardial Effusion

  MAUDE report 50070271 ↗
• InjuryJul 28, 2026Patient-Device Incompatibility

  It was reported on (b)(6) 2026 a 22 mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using a 14F Amplatzer Amulet delivery sheath for a left atrial appendage (LAA) closure. Prior to the procedure, a baseline trivial pericardial effusion presenting as transverse sinus fluid was noted. During the procedure, the activating clotting time (ACT) was above 287 seconds, and a total of Heparin 15,000 units was administered. The heart rhythm was atrial fibrillation and the left atrial pressure was 16 mmHg. Transseptal was made at the inferior and mid-to-anterior location. The wire was positioned in the left upper pulmonary vein (LUPV). The device was implanted. Protamine 50 mg was administered. The following day, the patient had chest pain. Transesophageal echocardiogram confirmed a small circumferential pericardial effusion. The physician believed the chest pain was from pericarditis due to the pericardial effusion. The patient was monitored and discharged with Colchicine. The patient status was stable. The patient was taking Aspirin and Plavix at the time the pericardial effusion was dedicated.

  Patient problems: Angina; Pericardial Effusion; Pericarditis

  MAUDE report 50056591 ↗
• MalfunctionMay 11, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING AN 12F AMULET DELIVERY SYSTEM. THE PROCEDURE INVOLVED A DIFFICULT LEFT ATRIAL APPENDAGE (LAA) CLOSURE DUE TO A SMALL, SHALLOW APPENDAGE, WHICH REQUIRED A VERY ANTERIOR TRANSSEPTAL PUNCTURE TO FACILITATE CANNULATION OF THE APPENDAGE WITH THE DELIVERY SYSTEM. AN 25 MM AMPLATZER AMULET DEVICE WAS INITIALLY ATTEMPTED; HOWEVER, THIS DEVICE WAS ASSESSED TO BE TOO LARGE AND WAS REMOVED. THE PROCEDURE WAS CONTINUED USING A 22 MM AMPLATZER AMULET, DURING WHICH THE DEVICE FORMED A COBRA HEAD CONFIGURATION WHEN TRANSITIONING FROM THE BALL POSITION TO THE TRIANGLE CONFIGURATION. THE DEVICE WAS RESHEATHED, AND A SECOND ATTEMPT WAS MADE TO DEPLOY THE DEVICE IN THE BALL POSITION, BUT THE COBRA HEAD CONFIGURATION RECURRED. 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 DEVICE WAS THEN EXCHANGED FOR ANOTHER NEW 22 MM AMPLATZER AMULET, WHICH WAS SUBSEQUENTLY DEPLOYED SUCCESSFULLY WITHOUT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143475 ↗
• MalfunctionApr 3, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET WAS IMPLANTED USING AN UNKNOWN DELIVERY SYSTEM. ON (B)(6) 2025, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED, WHICH DEMONSTRATED A POTENTIAL PERI-DEVICE LEAK AROUND THE AMULET. THE POTENTIAL GAP AND LEAK WERE OBSERVED LATERAL TO THE DEVICE. THE LEAK WAS MEASURED AT APPROXIMATELY 1.7 MM ON ECHOCARDIOGRAPHY, AND FIELD TRAINERS ASSESSED THAT THE LEAK WAS LESS THAN 5 MM. NO INTERVENTIONS WERE PERFORMED TO ADDRESS THE LEAK, AND THE PHYSICIAN ELECTED TO CONTINUE MONITORING WITHOUT CORRECTIVE ACTION AT THIS TIME. THE PATIENT WAS REPORTED TO BE STABLE, WITH NO KNOWN CLINICAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780316 ↗
• DeathMar 31, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMPLATZER AMULET DELIVERY SYSTEM. PRIOR TO THE IMPLANT, THE PATIENT¿S CONDITION WAS REPORTED AS GOOD, WITH NO SYMPTOMS, ATRIOVENTRICULAR (AV) BLOCK III, AND STABLE CIRCULATION. PRE-PROCEDURAL SIZING WAS DETERMINED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) USING THE MANUFACTURER¿S SIZING CHART, WITH LANDING ZONE MEASUREMENTS RECORDED AS 17 MM AT 0°, 18 MM AT 45°, 16 MM AT 90°, AND 18 MM AT 135°. TEE WAS UTILIZED AS THE IMAGING MODALITY THROUGHOUT THE PROCEDURE. THE DEVICE WAS DEPLOYED WITH A TIRE-SHAPED CONFIGURATION, AND A TENSION TEST WAS PERFORMED, AFTER WHICH NO PERI-DEVICE LEAK WAS DETECTED AROUND THE LOBE. APPROXIMATELY 250 ML OF FLUID WAS ADMINISTERED DURING THE PROCEDURE. THE IMPLANTER REPORTED THAT THE CLOSE CRITERIA WERE MET, AND ALL CRITERIA WERE VERIFIED MULTIPLE TIMES. THE IMPLANTATION WAS CONSIDERED SUCCESSFUL, AND NO SYMPTOMS WERE NOTED AT THE CONCLUSION OF THE PROCEDURE DESPITE THE ABSENCE OF SINUS RHYTHM. ON (B)(6) 2026 (DAY 10 POST-IMPLANT), THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH MALAISE AND DYSPNEA/SHORTNESS OF BREATH. A TRANSTHORACIC ECHOCARDIOGRAM SUBSEQUENTLY CONFIRME

  Patient problems: Dyspnea; Fatigue; Shock

  MAUDE report 24749648 ↗
• InjuryMar 30, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT (b)(6) 2026, A 22MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. NO PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED AT AN INFERIOR POSTERIOR LOCATION. AT THE TIME OF THE PROCEDURE, THE PATIENT WAS IN SINUS RHYTHM, WITH A LEFT ATRIAL PRESSURE OF 12 MMHG. HEPARIN WAS ADMINISTERED AT A DOSE OF 100 E/KG, ACHIEVING AN ACTIVATED CLOTTING TIME (ACT) GREATER THAN 250 SECONDS.THE LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEEDED SMOOTHLY, WITH NO REPORTED DIFFICULTY OR MULTIPLE MANIPULATIONS DURING DEVICE IMPLANTATION. THE 22 MM AMPLATZER AMULET DEVICE WAS POSITIONED IN A WINDSOCK-TYPE LAA ANATOMY IN A SEMI-SANDWICH CONFIGURATION. SEVERAL HOURS AFTER THE LAA CLOSURE, THE PATIENT DEVELOPED SYMPTOMS CONSISTENT WITH CARDIAC TAMPONADE. FURTHER EVALUATION REVEALED A CIRCUMFERENTIAL PERICARDIAL EFFUSION, WITH THE LARGEST DIMENSION MEASURING APPROXIMATELY 1.5 CM, WHICH WAS NOTED IN THE REGION OF THE LEFT ATRIAL APPENDAGE. STABILIZATION MEASURES WERE INITIATED, INCLUDING PLACEMENT OF A PERICARDIAL DRAIN. INITIALLY, THERE WAS SIGNIFICANT BLOOD LOSS THROUGH THE DRAIN, WHICH SUBSEQUENTLY DECREASED TO APPROXIMATELY

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion

  MAUDE report 24720079 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24683812 ↗
• InjuryMar 13, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET WAS IMPLANTED. PRE-PROCEDURAL ASSESSMENT DOCUMENTED LEFT ATRIAL APPENDAGE OSTIUM DIMENSIONS OF 14X19MM, AND DEVICE SIZING WAS DETERMINED USING ECHOCARDIOGRAPHY AND FLUOROSCOPY. INTRAPROCEDURAL IMAGING WAS PERFORMED WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), DURING WHICH NO RHYTHM CHANGE WAS OBSERVED AND NO PERI-DEVICE LEAK WAS DETECTED. AT THE 60-DAY FOLLOW-UP ON (B)(6) 2026, ECHOCARDIOGRAPHY IDENTIFIED THE DEVICE IN THE DESCENDING AORTA. THE PATIENT REMAINED ASYMPTOMATIC, WITH NO CLINICAL SIGNS OR SYMPTOMS, ASIDE FROM ELEVATED BLOOD PRESSURE. THE DEVICE WAS DETERMINED TO HAVE COMPLETELY DISLODGED FROM THE INTENDED IMPLANT SITE, WITH THE IMPLANTER ATTRIBUTING THE EVENT TO UNDER SIZING. THE EMBOLIZED DEVICE RESULTED IN A PARTIAL OBSTRUCTION OF BLOOD FLOW IN THE DESCENDING AORTA. ON (B)(6) 2026, THE DEVICE WAS SUCCESSFULLY REMOVED PERCUTANEOUSLY WITHOUT COMPLICATIONS.

  Patient problems: High Blood Pressure/ Hypertension; Obstruction/Occlusion

  MAUDE report 24597383 ↗
• InjuryMar 6, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER TORQVUE DELIVERY SHEATH. THE PATIENT WAS IN NORMAL SINUS RHYTHM AT THE START OF THE PROCEDURE AND HAD TAKEN ELIQUIS THE DAY BEFORE THE PROCEDURE. A TRANSSEPTAL PUNCTURE WAS PERFORMED IN THE INFERIOR MID LOCATION. THE WIRE WAS POSITIONED IN THE UPPER PULMONARY VEIN, AND THERE WERE NO MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES. THE PATIENT¿S LEFT ATRIAL PRESSURE MEASURED 22MMHG, AND THE ACTIVATED CLOTTING TIME (ACT) DURING THE PROCEDURE WAS 289 SECONDS. THE PATIENT RECEIVED 7,000 UNITS OF HEPARIN, AND NO WIRE WAS EVER PLACED IN THE LEFT ATRIAL APPENDAGE. THE PATIENT UNDERWENT THE AMULET PROCEDURE AT APPROXIMATELY 9:30 A.M., DURING WHICH A 0.6 CM PERICARDIAL EFFUSION WAS NOTED. THE DEVICE WAS SUCCESSFULLY DEPLOYED ON THE FIRST ATTEMPT. FOLLOWING THE PROCEDURE, THE EFFUSION WAS REASSESSED AND AGAIN MEASURED 0.6 CM. AT THE CONCLUSION OF THE CASE, 50 UNITS OF PROTAMINE WERE ADMINISTERED. APPROXIMATELY 1.5 HOURS LATER, THE TEAM WAS INFORMED THAT THE PATIENT HAD DEVELOPED CARDIAC TAMPONADE, AND A BEDSIDE PERICARDIOCENTESIS WAS SUBSEQUENTLY PERFORMED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24536505 ↗
• InjuryMar 6, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) A 22MM AMPLATZER AMULET WAS IMPLANTED USING 14F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, NO PERICARDIAL EFFUSION HAD BEEN NOTED PRIOR TO THE INTERVENTION, AND HEPARIN WAS ADMINISTERED PER PROCEDURAL PRACTICE. A TRANSSEPTAL PUNCTURE WAS PERFORMED IN THE INFERIOR ANTERIOR LOCATION, AND ACCESS TO THE LEFT ATRIUM WAS ACHIEVED. THE NON-ABBOTT WIRE WAS PLACED IN THE LEFT ATRIAL APPENDAGE, AFTER WHICH THE PROCEDURE PROCEEDED WITH ADVANCEMENT OF THE DELIVERY SYSTEM. THERE WERE NO MULTIPLE WIRE OR SHEATH EXCHANGES, AND THE WIRE POSITION REMAINED IN THE MID LEFT ATRIUM THROUGHOUT DEVICE PREPARATION AND DEPLOYMENT. HEMODYNAMIC ASSESSMENT SHOWED A LEFT ATRIAL PRESSURE OF 10 MMHG AT THE TIME OF THE PROCEDURE. THE OCCLUDER DEVICE WAS THEN INTRODUCED AND DEPLOYED WITHOUT IMMEDIATE COMPLICATION. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY ROOM, WHERE A CIRCUMFERENTIAL PERICARDIAL EFFUSION WAS IDENTIFIED. A TOTAL OF 300CC WAS DRAINED, AND IT WAS NOTED THAT THERE WAS NO PRESENCE OF TAMPONADE. THE PATIENT REMAINED STABLE. THE USER LATER REPORTED A BELIEF THAT THE EFFUSION WAS CAUSED BY AN ABBOTT DEVICE, SPECIFICALLY IDENTIFYING THE AMULET.

  Patient problems: Pericardial Effusion

  MAUDE report 24536301 ↗
• InjuryMar 2, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. EARLIER IN THE PROCEDURE, THE DEVICE WAS IMPLANTED WITH ONE RECAPTURE DURING DEPLOYMENT, AND FLUID WAS OBSERVED IN THE TRANSVERSE SINUS ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING; HOWEVER, NO WORSENING WAS IDENTIFIED AT THAT TIME. A FEW HOURS AFTER THE AMULET IMPLANT, A PERICARDIAL EFFUSION WAS NOTED IN THE PATIENT. A PERICARDIOCENTESIS (TAP) WAS SUBSEQUENTLY PERFORMED SUCCESSFULLY, AND THE PATIENT WAS REPORTED TO BE DOING WELL FOLLOWING THE INTERVENTION.

  Patient problems: Dyspnea; Pericardial Effusion

  MAUDE report 24490278 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 12F AMULET DELIVERY SYSTEM. THE PROCEDURE WAS DESCRIBED AS UNCOMPLICATED. PRE-OPERATIVE PLANNING INCLUDED 3MENSIO AND FEOPS ASSESSMENTS AND NO PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. A ROUTINE TRANSSEPTAL PUNCTURE WAS PERFORMED AT AN INFERIOR/SUPERIOR LOCATION. DURING THE PROCEDURE, THE PATIENT REMAINED IN AF/SR, AND THE ACTIVATED CLOTTING TIME (ACT) WAS MAINTAINED ABOVE 300 SECONDS THROUGHOUT. THE PATIENT HAD BEEN TAKING ORAL ANTICOAGULATION AND ASPIRIN PRIOR TO THE PROCEDURE, AND THIS REGIMEN CONTINUED AT THE TIME THE LATER PERICARDIAL EFFUSION WAS DETECTED. HEPARIN WAS ADMINISTERED INTRA-PROCEDURALLY, WITH 5,000 UNITS INITIALLY FOLLOWED BY AN ADDITIONAL 2,000 UNITS. NO PROTAMINE OR OTHER REVERSAL AGENTS WERE USED. THE WIRE POSITION WAS MAINTAINED IN THE LEFT UPPER PULMONARY VEIN, AND THERE WERE NO MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES. THE LEFT ATRIAL PRESSURE AT THE TIME OF THE PROCEDURE WAS 11 MMHG. A WIRE WAS NOT PLACED IN THE LEFT ATRIAL APPENDAGE AT ANY POINT. THE FIRST DEVICE WAS PARTIALLY RECAPTURED ONCE AND FULLY RECAPTURED ONCE, THEN REMOVED DUE TO MISSIZING.

  Patient problems: Pericardial Effusion

  MAUDE report 24298684 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22 MM AMPLATZER AMULET DEVICE WAS SELECTED FOR IMPLANT. INITIALLY A 25 MM AMPLATZER AMULET DEVICE WAS ATTEMPTED FIRST; HOWEVER, DUE TO POOR SHEATH COAXIALITY, A NEW TRANSEPTAL PUNCTURE WAS SUGGESTED. THEREFORE, THE PHYSICIAN ELECTED TO TRY A SMALLER 22 MM DEVICE. DURING THE PROCEDURE, INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING APPEARED TO SHOW A POTENTIAL CLOT AT THE END OF THE DELIVERY SHEATH OR DEVICE. THE ICE IMAGE SHOWED SOMETHING LONG AND ¿STRINGY¿ APPEARING TO HANG FROM THE SHEATH OR DEVICE. BASED ON THIS OBSERVATION, THE PHYSICIAN CHOSE TO RECAPTURE THE DEVICE AND REMOVE BOTH THE DEVICE AND THE SHEATH FROM THE PATIENT. UPON INSPECTION OUTSIDE THE BODY, NO MATERIAL CONSISTENT WITH A CLOT WAS IDENTIFIED ON EITHER THE DEVICE OR THE SHEATH. AFTER THEIR REMOVAL, THE PHYSICIAN REVIEWED ICE IMAGING AGAIN TO ASSESS THE CARDIAC STRUCTURES, AT WHICH TIME A STRUCTURE WAS NOTED TO BE ATTACHED TO ONE OF THE AORTIC VALVE LEAFLETS. THE PHYSICIAN BELIEVED THIS STRUCTURE COULD REPRESENT EITHER A CLOT OR SHAVINGS FROM THE SHEATH. GIVEN THIS FINDING, THE DECISION WAS MADE TO DISCONTINUE THE PROCEDURE. NEITHER AMULET DEVICE WAS IMPLANTED. THE PATIENT REMA

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24226207 ↗
• InjuryJan 28, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 22MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 12F AMULET DELIVERY SYSTEM FOR A LAAO PROCEDURE DURING A LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE. PRIOR TO IMPLANT, LANDING ZONE MEASUREMENTS WERE OBTAINED USING A 3D CT SCAN, SHOWING A MINIMUM DIMENSION OF 14.7 MM, MAXIMUM OF 22 MM, AND AN AVERAGE OF 18.4 MM. DEVICE SIZING WAS DETERMINED USING CT IMAGING ALONG WITH INTRA-PROCEDURAL FLUOROSCOPY AND INTRACARDIAC ECHOCARDIOGRAPHY (ICE). DURING THE PROCEDURE, FLUOROSCOPY AND ICE WERE USED FOR IMAGING GUIDANCE. A 22 MM AMPLATZER AMULET WAS SELECTED FOR IMPLANT USING A 12F AMULET DELIVERY SYSTEM. THE DEVICE WAS ADVANCED TO THE LEFT ATRIAL APPENDAGE, AND THE STABILITY TEST WAS PERFORMED PER PROTOCOL. AT THE TIME OF IMPLANT, THE DEVICE EXHIBITED A ¿TIRE¿ SHAPE. THE CLOSE CRITERIA WERE REPORTED AS SATISFIED, AND A TENSION (TUG) TEST WAS PERFORMED. NO PERI-DEVICE LEAK WAS OBSERVED AROUND THE LOBE (NO LEAK). THE DEVICE WAS THEN RELEASED. A FEW MINUTES AFTER RELEASE, THE AMPLATZER AMULET EMBOLIZED AND WAS OBSERVED FLOATING FREELY IN THE LEFT ATRIUM WITHOUT CROSSING THE VALVE. THE DEVICE HAD COMPLETELY DISLODGED FROM THE IMPLANT SITE. THE EMBOL

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203206 ↗
• DeathJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMULET DELIVERY SYSTEM UNDER TEE GUIDANCE. DEVICE SIZING WAS INSTEAD DETERMINED ON THE DAY OF THE CASE USING TEE MEASUREMENTS. THE LANDING ZONE MEASUREMENTS OBTAINED VIA TEE WERE 17, 16, 17, AND 19 MM AT 0, 45, 90, AND 135 DEGREES, RESPECTIVELY, AND BASED ON THE IFU SIZING CHART, A 22MM DEVICE WAS SELECTED. DURING THE PROCEDURE, THE PATIENT DID NOT EXPERIENCE ANY RHYTHM CHANGES. A NON- ABBOTT WIRE WAS PLACED IN THE LEFT ATRIAL APPENDAGE, AND THE PATIENT¿S LEFT ATRIAL PRESSURE MEASURED 13 MMHG. THE DEVICE REQUIRED THREE PARTIAL RECAPTURES/REPOSITIONING ATTEMPTS BEFORE FINAL DEPLOYMENT, AND AT THE TIME OF IMPLANT, THE DEVICE EXHIBITED TIRE/BARREL COMPRESSION. THE PATIENT WAS DISCHARGED ON THE SAME DAY. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH AND WAS FOUND TO BE IN MULTI-ORGAN FAILURE. THE PATIENT SUBSEQUENTLY PASSED AWAY. THE CAUSE OF DEATH WAS DETERMINED TO BE MULTI-ORGAN FAILURE, AND THE IMPLANTER CLASSIFIED THE EVENT AS BEING RELATED TO THE PROCEDURE AND THE PATIENT¿S COMORBIDITIES.

  Patient problems: Shock

  MAUDE report 24192620 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22 MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14FAMPLATZER TORQVUE DELIVERY SHEATH IN A 79-YEAR-OLD FEMALE PATIENT. THE PROCEDURE INVOLVED ONE DEPLOYMENT OF THE DEVICE. DURING THE PROCEDURE, TWO TRANSEPTAL PUNCTURES WERE PERFORMED DUE TO LOSS OF ACCESS IN THE LEFT ATRIUM. THE DEVICE INITIALLY MOVED BACK PROXIMALLY UPON DEPLOYMENT BUT MET CLOSE CRITERIA AND PASSED THE TUG TEST. FOLLOWING DEPLOYMENT, THE TEE PHYSICIAN IDENTIFIED A PERICARDIAL EFFUSION LOCATED ON THE POSTERIOR WALL. THE EFFUSION MEASURED APPROXIMATELY 6 MM AND WAS NOTED TO BE CIRCUMFERENTIAL. THE EFFUSION WAS MONITORED FOR 10 MINUTES AND APPEARED STABLE WITHOUT FURTHER ENLARGEMENT. THE ECHOCARDIOGRAPHY PROBE WAS SUBSEQUENTLY REMOVED, AND THE PATIENT WAS SCHEDULED TO REMAIN IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. ADDITIONAL INFORMATION FROM THE ACCOUNT IS EXPECTED TO BE PROVIDED LATER.

  Patient problems: Pericardial Effusion

  MAUDE report 24035675 ↗
• InjuryJan 2, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SHEATH. FOLLOWING THE AMULET PROCEDURE, THE PATIENT WAS FOUND TO BE NON-RESPONSIVE, AND A CODE WAS INITIATED. THE PATIENT WAS NOTED TO HAVE PULSELESS ELECTRICAL ACTIVITY. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, AND PERICARDIOCENTESIS WAS CONDUCTED, WITH 280 CC OF FLUID DRAINED. THE PATIENT WAS STABILIZED AND INTUBATED. EXTUBATION WAS PLANNED FOR (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23950635 ↗
• InjuryDec 24, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMPLATZER TORQVUE DELIVERY SHEATH. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH AND WAS FOUND TO HAVE AN EMBOLIZED AMULET DEVICE TEN DAYS POST-IMPLANT. THE PATIENT SUBSEQUENTLY UNDERWENT A MINI LATERAL THORACOTOMY WITH EXCISION OF THE DEVICE, MITRAL VALVE REPAIR, AND LEFT ATRIAL APPENDAGE (LAA) LIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Dyspnea

  MAUDE report 23888485 ↗
• InjuryDec 24, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22 MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMULET DELIVERY SHEATH. ON (B)(6) 2025, 24 HOURS AFTER THE IMPLANT IT WAS OBSERVED THAT THE A MODERATE PERICARDIAL EFFUSION WAS PRESENT REQUIRING A PERICARDIAL WINDOW. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 23888482 ↗
• InjuryDec 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMULET DELIVERY SHEATH IN A REVERSE CHICKEN WING ANATOMY. THE TRANSSEPTAL PUNCTURE WAS PERFORMED IN AN INFERIOR AND MEDIAL POSITION OF POSTERIOR-ANTERIOR ORIENTATION, AS THIS APPROACH IS RECOMMENDED FOR REVERSE CHICKEN WING ANATOMY. DURING THE PROCEDURE, AT THE POINT OF DEPLOYING THE DEVICE, THE SHEATH WAS POSITIONED VERY DEEP, AND THE PREFERRED STRATEGY WAS TO WITHDRAW THE SHEATH RATHER THAN ADVANCE THE CABLE. DESPITE THIS ADJUSTMENT, THE FIRST CONTRAST INJECTION REVEALED THE PRESENCE OF PERICARDIAL EFFUSION, INDICATING THAT THE LEFT ATRIAL APPENDAGE HAD BEEN PERFORATED BY THE DISTAL TIP OF THE DEVICE (DISTAL SCREW). THE PERICARDIAL EFFUSION WAS NOTED INTRAPROCEDURAL AT THE MOMENT OF DELIVERING THE BALL INSIDE THE LEFT ATRIAL APPENDAGE. IT WAS LOCATED IN THE LEFT ATRIAL APPENDAGE AND RESOLVED WITH PERICARDIOCENTESIS. THE OPERATOR BELIEVED THE EFFUSION WAS CAUSED BY AN ABBOTT DEVICE, SPECIFICALLY THE DISTAL SCREW. THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) DURING THE PROCEDURE WAS 250. HEPARIN WAS ADMINISTERED, THOUGH THE EXACT AMOUNT IS PENDING CONFIRMATION. THE GREATEST DIFFICULTY ENC

  Patient problems: Cardiac Tamponade; Perforation; Pericardial Effusion

  MAUDE report 23881944 ↗
• DeathDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 12F AMULET DELIVERY SHEATH FOR A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE. THE PATIENT¿S CONDITION PRIOR TO THE PROCEDURE WAS REPORTED AS PERMANENT ATRIAL FIBRILLATION (AF), STABLE, WITH A HISTORY OF AMYLOID ENCEPHALOPATHY. THE PROCEDURE WAS PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND FLUOROSCOPY GUIDANCE AND WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND WAS REPORTED TO BE STABLE IMMEDIATELY POST-PROCEDURE AND AT DISCHARGE. NO ECG CHANGES OR ARRHYTHMIAS WERE NOTED BEFORE DISCHARGE, AND THE PATIENT WAS COMPLIANT WITH PRESCRIBED MEDICATIONS, INCLUDING ANTICOAGULANTS AND ANTIPLATELETS. FOLLOWING THE PRESCRIBED HOSPITALIZATION PERIOD, THE PATIENT WAS DISCHARGED WITHOUT ANY REPORTED ADVERSE EVENTS. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL IN CARDIAC ARREST A FEW DAYS AFTER DISCHARGE. PRIOR TO THE CARDIAC ARREST, THE PATIENT EXPERIENCED SYNCOPE AND CHEST PAIN. RESUSCITATION EFFORTS WERE UNSUCCESSFUL, AND THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST WITH PR

  Patient problems: Angina; Cardiac Arrest; Myocardial Infarction; Syncope/Fainting

  MAUDE report 23881821 ↗