Amplatzer™ Amulet™ 9-ACP2-010-031Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 00811806013510), received between Sep 1, 2021 and Sep 18, 2026 — classified as 11 deaths, 113 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (67 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 145 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 31mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. On follow up transthoracic echocardiogram (TTE) prior to discharge, it was noted that the Amulet device had embolized to the left ventricle (LV). The patient was stable without symptoms. The patient underwent a procedure to retrieve the embolized device via a retrograde aortic approach. The device was retrieved successfully. The patient remained hemodynamically stable throughout the time the device was discovered to be in the LV and was retrieved. There was no damage to the mitral valve or aortic valve was noted. There was no change to the patient's heart function post device retrieval was noted. The patient was kept overnight for monitoring.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817237 ↗
• InjurySep 4, 2026Patient Device Interaction Problem

  It was reported on (b)(6) 2026 a 34mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for left atrial appendage closure (LAAC) using a 14F Amulet Delivery Sheath. The landing zone was measured under the following views: 28.8mm at 0 degrees, 26.7mm at 45 degrees, 29.3mm at 90 degrees, and 35.4mm at 135 degrees. The LAA had a perimeter of 98.1mm. During the procedure, approximately 15 seconds after the first deployment attempt, the device on the superior side at 90 degrees and posterior side at 135 degrees was observed to shift proximally as though being pushed outward. The 34mm Amulet was determined to be oversized. The device was removed from the patient and down-sized to a new 31mm Amplatzer Amulet Left Atrial Appendage Occluder. During the first deployment attempt, the 31mm Amulet was positioned above the pectinate muscles. However, the same issue occurred with the device shifting proximally. A partial re-capture was performed, and the device was re-deployed with the intention of anchoring at the most posterior pectinate muscle. Lobe configuration was barrel-shaped with a lobe leak observed on the posterior side. During the tug test, contact on the posterior side cha

  Patient problems: Arrhythmia; Bradycardia; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 50616039 ↗
• InjuryAug 13, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 31mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. The sizing of the device was determined by FEops. During procedure, two different sized devices were attempted and this was the third attempt of the second size. The left atrial pressure was 10mmgh initially so saline was given, later over 12mmhg. The Amulet was implanted after satisfying CLOSE criteria and tension test was performed. The shape of the device was Marshmallow or slightly above, not a roman helmet. The implanted Amulet was embolized that evening. A transcatheter retrieval was performed but, unsuccessful so surgery is being considered. The Amulet was currently in the left ventricle apex. Later the device got removed and the patient was reported recovering.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240604 ↗
• InjuryAug 6, 2026Migration or Expulsion of Device

  It was reported on (b)(6) 2026 a 31 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. Intracardiac echocardiography (ICE) imaging was used during the procedure. The landing zone measurements were 28 mm at 0 degrees, 26 mm at 45 degrees, 26.8 mm at 90 degrees, and 27 mm at 135 degrees. The left atrial pressure was above 12 mmHg. The lobe was not able to be properly seated due to the presence of pectinate muscles requiring two partial recaptures. No leak was detected. CLOSE criteria were met and a tension test was performed. The device was implanted. The observed device shape was Roman Helmet. The following day, x-ray angiogram confirmed the device had embolized to the left atrium. The device was surgically removed via open heart surgery. The patient status was stable. The physician believed the presence of the pectinate muscles caused the device embolization.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161942 ↗
• DeathAug 3, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026 a 31 mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using an unknown delivery sheath for a left atrial appendage (LAA) closure. Computed tomography (CT) measured the landing zone with a minimum of 19.7 mm and a maximum of 27.5mm. During the procedure, the left atrial pressure was 12 mmHg. Heparin was administered. Transseptal was made at the inferior and mid location. The Non-Abbott wire was positioned in the LAA. One deployment of the device was made. The device was implanted. About 4 hours after the procedure the patient went into cardiac arrest. Cardiopulmonary Resuscitation (CPR) was initiated and a pericardial effusion (PE) developed during CPR. A pericardiocentesis was performed during cardiac arrest and approximately 1000 ml of fluid was removed. CPR was unsuccessful and the patient expired. The autopsy report showed a large tear in the superior vena cava and device interaction with the pulmonary artery, resulting in a pulmonary artery injury. The physician believed the device in combination of the patient's comorbidities was the cause of death.

  Patient problems: Cardiac Arrest; Perforation; Pericardial Effusion

  MAUDE report 50117649 ↗
• InjuryJul 29, 2026Migration or Expulsion of Device

  It was reported on 06 July 2026 a 31 mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using an unknown delivery sheath for a left atrial appendage (LAA) closure. Imaging modalities used during the procedure were computed tomography (CT), angiography, and transoesophageal echocardiogram (TOE). During the procedure the landing zone measurements averaged 17 mm to 24 mm in all dimensions. The left atrial pressure was 15 mmHg and minimal amount of fluid was given. No repositioning was required. No Leak was detected. CLOSE criteria were satisfied and a tension test was performed. The device was implanted. After 5 minutes, a rhythm change was noted. The device was found to have embolized into the left ventricle. A Non-Abbott sheath was inserted into the patient's left groin to snare the device. Multiple snare attempts were made. At one point during snaring, the snare capture was lost and the device traveled to the descending aorta. The device was retrieved and removed from the body. Additional Heparin 3000 units was given maintain the activating clotting time (ACT) above 250 seconds. Both left and right groin were closed with closure devices. No pericardial effu

  Patient problems: Arrhythmia

  MAUDE report 50070388 ↗
• MalfunctionJul 2, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED ON (B)(6) 2026 A 31 MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LAAO) WAS SELECTED FOR IMPLANT USING AN UNKNONWN DELIVERY SHEATH FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE. THE DEVICE WAS NOTED TO BE DEFECTIVE WITH THE SIDES APPEARING DENTED. THE DEVICE WAS REPLACED WITH A NEW 28 MM AMPLATZER AMULET LAAO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25691861 ↗
• MalfunctionJun 15, 2026Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025 A 34 MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LAAO) WAS SELECTED FOR IMPLANT USING A 14F TORQVUE DELIVERY SHEATH FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE. THE IMAGING MODALITY USED FOR THE PROCEDURE AND TO DETERMINE THE DEVICE WAS TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE DEVICE WAS RESIZED AND A 31 MM AMPLATZER AMULET LAAO WAS SELECTED FOR IMPLANT. THE DEVICE WAS RE-SHEATHED. THE LANDING ZONE MEASUREMENTS AT 0 DEGREES WAS 25 MM, 45 DEGREES WAS 20 MM, 90 DEGREES WAS 27 MM, AND 135 DEGREES WAS 21 MM. DURING THE PROCEDURE THE LEFT ATRIAL PRESSURE WAS BELOW 12 MM HG. FLUID WAS GIVEN. THE DEVICE WAS REPOSITIONED TWICE. CLOSE CRITERIA WERE MET. A TENSION TEST WAS PERFORMED. THE DEVICE WAS IMPLANTED. THE DEVICE SHAPE AT THE TIME OF IMPLANT WAS ROMAN HELMET. AT A FOLLOW UP APPOINTMENT ON (B)(6) 2026, IT WAS NOTED ON TEE THE DEVICE SHIFTED IN POSITION BUT WAS STILL IMPLANTED. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25506055 ↗
• InjuryMar 24, 2026Patient Device Interaction Problem

  CLINICAL INFORMATION: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE USING A AMULET¿ STEERABLE DELIVERY SHEATH. THE LAA DEPTH WAS 24MM AND THE SHAPE OF THE APPENDAGE WAS CHICKEN WING. THE LEFT ATRIAL PRESSURE WAS 11 MMHG AND ATRIAL RHYTHM RECORDED AT START OF PROCEDURE WAS SINUS RHYTHM. THE ACTIVATED CLOTTING LEVELS WERE 234,255S AND HEPARIN WAS GIVEN. THE 28MM AMULET WAS NOT IMPLANTED DUE TO INCOMPATIBLE WITH ANATOMY. A NEW 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2026, THE PATIENT HAD A CARDIOVERSION DUE TO ATRIAL FIBRILLATION (AF) AND TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED A 3MM PERI DEVICE LEAK. THERE WAS NO THROMBUS WAS NOTED IN THE AMULET. THE PATIENT WAS INITIATED WITH 5MG APIXABAN TWICE DAILY. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681741 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 31MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER AMULET DELIVERY SYSTEM. HEPARIN WAS ADMINISTERED AS PER USUAL PROCEDURAL INDICATIONS; HOWEVER, THE PHYSICIAN DID NOT PROVIDE THE EXACT ACTIVATED CLOTTING TIME (ACT) LEVELS. THE MITRACLIP PROCEDURE WAS PERFORMED FIRST, FOLLOWED BY THE LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE. AT THE END OF THE PROCEDURES, THE PATIENT DEVELOPED BLEEDING FROM THE MOUTH AT THE SITE WHERE THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE HAD BEEN POSITIONED. THE BLEEDING RESOLVED WITHIN APPROXIMATELY TEN MINUTES. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT AS PER STANDARD POST-PROCEDURAL PRACTICE AND WAS REPORTED TO BE STABLE. ON THE FOLLOWING MORNING, THE PATIENT WAS TRANSFERRED URGENTLY TO THE SURGICAL OPERATING UNIT WITH A DIAGNOSIS OF ESOPHAGEAL LACERATION WITH HEMODYNAMIC COMPROMISE. THE PATIENT UNDERWENT ESOPHAGEAL RECONSTRUCTION SURGERY. ACCORDING TO THE PHYSICIAN, THE ESOPHAGEAL LACERATION WAS BELIEVED TO HAVE RESULTED FROM SCRAPING DURING INTUBATION AND TEE PROBE INSERTION, AND THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE ABBOTT DEVICE OR THE PROCEDURE. THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s) of Esophagus

  MAUDE report 24666584 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED IN THE PATIENT. THE PATIENT DISCHARGED ON PLAVIX AND ASPIRIN (ASA) FOR 6 MONTHS. AT 6 MONTHS, TAKEN OFF PLAVIX, REMAINED ON ASA. THE 45 DAY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED NO LEAK, NO DEVICE RELATED THROMBUS (DRT). ON (B)(6) 2026, THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL WITH STROKE SYMPTOMS AND CONFIRMED TO HAVE ACUTE LEFT P2 OCCLUSION. THEY DECIDED TO RETURN PATIENT TO ELIQUIS FOR 3 MONTHS, AND RE-IMAGE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Obstruction/Occlusion; Stroke/CVA

  MAUDE report 24648390 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 28MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMULET DELIVERY SHEATH DURING A LEFT ATRIAL APPENDAGE OCCLUSION PROCEDURE PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) GUIDANCE, WITH TEE USED AS THE IMAGING MODALITY TO DETECT THE THROMBUS. PRIOR TO THE FINAL IMPLANT, A BROCCOLI-SHAPED LEFT ATRIAL APPENDAGE WITH TWO TO THREE LOBES WAS IDENTIFIED, AND A 31-MM AMPLATZER AMULET DEVICE WAS INITIALLY SELECTED. THE DELIVERY SHEATH HAD BEEN INTRODUCED EARLIER IN THE PROCEDURE, AND APPROXIMATELY 1 HOUR AND 9 MINUTES ELAPSED FROM SHEATH INSERTION TO THE TIME THROMBUS FORMATION WAS OBSERVED. DURING PLACEMENT OF THE 31-MM DEVICE, A SLUDGE-LIKE LINEAR ECHO WAS OBSERVED AROUND THE DEVICE IN THE 135° ECHOCARDIOGRAPHIC VIEW. BECAUSE DOWNSIZING TO A 28-MM DEVICE HAD ALREADY BEEN PLANNED, THE 31-MM DEVICE WAS RETRIEVED WITHOUT FURTHER MANIPULATION, AND THROMBUS WAS SUBSEQUENTLY CONFIRMED TO BE ATTACHED TO BOTH THE RETRIEVED DEVICE AND THE DELIVERY CABLE; THE THROMBUS WAS DESCRIBED AS HAVING A DARK RED, LEECH-LIKE APPEARANCE, AND NO THREADS WERE OBSERVED ON THE DEVICE OR DELIVERY SYSTEM COMPONENTS. AT THE TIME THROMBUS WAS IDENTIFIED, THE REPORTED COAGU

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24597418 ↗
• InjuryMar 6, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 34-MM AMPLATZER AMULET DEVICE WAS INITIALLY CHOSEN FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE IN AN 80-YEAR-OLD FEMALE PATIENT. PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) DEMONSTRATED A WINDSOCK-TYPE LAA WITH A LANDING ZONE MEASURING 25.5 × 23.3 MM AND A MAXIMAL OSTIUM DIAMETER OF 25.6 MM. ADEQUATE DISTANCE FROM THE PULMONARY ARTERY WAS CONFIRMED AT THE INTENDED PROXIMAL DEPLOYMENT SITE. BASED ON TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) FINDINGS, A 34-MM AMPLATZER AMULET DEVICE WAS INITIALLY SELECTED; HOWEVER, THIS SIZE WAS DETERMINED TO BE INAPPROPRIATE, AND FULL RECAPTURE WAS PERFORMED. THE DEVICE WAS SUBSEQUENTLY DOWNSIZED TO A 31-MM AMPLATZER AMULET DEVICE, WITH NO PARTIAL RECAPTURE REQUIRED. FINAL ASSESSMENT SHOWED SATISFACTORY POSITIONING OF THE 31-MM DEVICE, WHICH WAS THEN RELEASED WITHOUT COMPLICATIONS. DUE TO A MARKEDLY ENLARGED LEFT ATRIUM, WARFARIN THERAPY WAS CONTINUED FOLLOWING THE PROCEDURE. ON (B)(6) 2026, THE PATIENT DEVELOPED HYPOTENSION DURING A DIALYSIS SESSION AT ANOTHER HOSPITAL AND WAS TRANSFERRED TO KOKURA MEMORIAL HOSPITAL FOR EVALUATION. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) REVEALED CIRCUMFERENTIAL PERICARDIAL EFFU

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24536090 ↗
• InjuryJan 30, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 28MM AMULET WAS CHOSEN FOR IMPLANT DURING A LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE. THE LEFT ATRIAL APPENDAGE (LAA) WAS DESCRIBED AS COMPLEX WITH SIGNIFICANT PECTINATE MUSCLES. MEASUREMENTS INDICATED AN OSTIUM SIZE OF 22¿33 MM AND A LANDING ZONE OF 21¿24 MM, AND SIZING SUPPORTED THE SELECTION OF A 28 MM AMULET DEVICE. AFTER DEPLOYMENT OF THE 28 MM DEVICE, A SMALL RESIDUAL GAP WAS OBSERVED ON THE MITRAL SIDE. AS A RESULT, A 31 MM AMPLATZER DEVICE WAS SELECTED AS A REPLACEMENT AND IMPLANTED USING AN UNKNOWN DELIVERY SYSTEM. FOLLOWING IMPLANTATION, THE GAP WAS NO LONGER PRESENT, CLOSURE CRITERIA WERE MET, AND THE DEVICE WAS RELEASED. SEVERAL HOURS LATER, THE RECOVERY UNIT REPORTED THAT THE PATIENT HAD DEVELOPED THIRD-DEGREE HEART BLOCK, PROMPTING PHYSICIAN REVIEW. A CHEST X-RAY AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) WERE ORDERED. THE TTE WAS INCONCLUSIVE; HOWEVER, THE CHEST X-RAY INDICATED THAT THE DEVICE WAS NOT IN ITS EXPECTED POSITION. A CT SCAN WAS SUBSEQUENTLY PERFORMED AND CONFIRMED THAT THE DEVICE HAD EMBOLIZED INTO THE AORTA. THE TEAM PROCEEDED WITH RETRIEVAL, AND THE DEVICE WAS SUCCESSFULLY REMOVED VIA SNARE FROM THE DESCENDING

  Patient problems: Atrial Fibrillation; Heart Block

  MAUDE report 24226248 ↗
• InjuryJan 20, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT. AFTER IMPLANTATION, IT WAS NOTED THAT THE DEVICE HAD EMBOLIZED POST PROCEDURE. LANDING ZONE MEASUREMENTS OBTAINED VIA ICE WERE AORTIC: 24MM, MITRAL: 28MM, AND SUPRAMITRAL: 24MM, AND SIZING WAS DETERMINED USING THE MAXIMUM ICE LANDING ZONE MEASUREMENT PLUS 3MM. INTRACARDIAC ECHO WAS USED DURING THE PROCEDURE, AND CT IMAGING IDENTIFIED THE MIGRATION. THE DEVICE COMPLETELY DISLODGED FROM THE IMPLANT SITE AND TRAVELED TO THE LEFT ATRIUM. CLOSE CRITERIA WERE SATISFIED, AND THE PATIENT REMAINED IN SINUS RHYTHM AFTER AF ABLATION THROUGHOUT THE IMPLANT. A TENSION TEST WAS PERFORMED, AND LEFT ATRIAL PRESSURE WAS ABOVE 12 MMHG. AT IMPLANT, THE DEVICE SHAPE WAS ROMAN HELMET, AND NO LEAK WAS DETECTED AROUND THE LOBE. THE PATIENT EXPERIENCED NO CLINICAL SIGNS OR SYMPTOMS, AND THERE WAS NO DIFFICULTY WITH IMPLANTING THE DEVICE, SUCH AS MULTIPLE RECAPTURES OR REPOSITIONING. SURGERY WAS PLANNED TO ADDRESS EMBOLIZATION, BUT COMPLETION IS UNCLEAR DUE TO COMPLEXITY AND A PLAN FOR CORONARY ARTERY BYPASS GRAFTING. THE EMBOLIZED DEVICE DID NOT CAUSE OBSTRUCTION OR BLOCKAGE OF BLOOD FLOW, AND RETRIEVAL WAS NOT CONSIDERED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122514 ↗
• InjuryDec 11, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM. IT WAS NOTED THAT THE DEVICE EMBOLIZED AFTER BEING DEPLOYED WHILE THE PATIENT WAS STILL HOSPITALIZED. THE DEVICE WAS EXPLANTED ON (B)(6) 2025, AND THE PATIENT IS CURRENTLY HOME AND STABLE WITH A NEW DEVICE IN PLACE. THE LANDING ZONE MEASUREMENTS USED TO DETERMINE THE DEVICE SIZE WERE 22, 23, 25, AND 27 AT 0°, 45°, 90°, AND 135° RESPECTIVELY.DEVICE SIZING WAS DETERMINED BY USING ALL AVAILABLE IMAGING AND MEASUREMENTS, INCLUDING COMPUTED TOMOGRAPHY (CT) ANALYSIS, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), INTRACARDIAC ECHOCARDIOGRAPHY (ICE), ANGIOGRAPHY (ANGIO), AND LEFT ATRIAL (LA) PRESSURE. IMAGING MODALITIES USED DURING THE PROCEDURE WERE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND ANGIOGRAPHY (ANGIO), AND THE EMBOLIZATION WAS IDENTIFIED VIA TRANSTHORACIC ECHOCARDIOGRAPHY (TTE). THE DEVICE COMPLETELY DISLODGED FROM THE IMPLANT SITE AND MIGRATED TO THE LEFT VENTRICLE (LV). THE IMPLANTER BELIEVES THE CAUSE OF EMBOLIZATION IS UNKNOWN BUT NOTED THAT UPON DEPLOYMENT OF THE FINAL DEVICE, THE LEFT ATRIAL (LA) PRESSURE WAS 22 MMHG (COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23784596 ↗
• InjuryDec 9, 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 31MM AMPLATZER AMULET WAS IMPLANTED USING 14F AMPLATZER TORQVUE DELIVERY SYSTEM. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AT AN INFERIOR/MID LOCATION. THE PATIENT WAS IN ATRIAL FIBRILLATION AT THE TIME OF THE PROCEDURE. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE LEFT ATRIAL PRESSURE WAS GREATER THAN 12 MMHG. DURING DEVICE IMPLANTATION, THERE WAS ONE PARTIAL RECAPTURE, AND THE WIRE WAS EXCHANGED IN THE LEFT UPPER PULMONARY VEIN (LUPV). NO WIRE WAS EVER PLACED IN THE LEFT ATRIAL APPENDAGE. THERE WERE NO MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES. A PERICARDIAL EFFUSION OCCURRED, REQUIRING PERICARDIOCENTESIS; HOWEVER, CARDIAC TAMPONADE WAS NOT CONCLUDED BY THE PHYSICIAN. THE DEVICE WAS PARTIALLY RECAPTURED ONCE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: Pericardial Effusion

  MAUDE report 23762183 ↗
• MalfunctionDec 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A PROCEDURE. DURING EXHAUST OPERATION, IT WAS NOTED THAT ONE METAL WIRE OF THE LOBE WAS BROKEN. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23746019 ↗
• InjuryDec 5, 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 31MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM TO CLOSE A CHALLENGING LEFT ATRIAL APPENDAGE (LAA). THE TRANSSEPTAL PUNCTURE WAS PERFORMED AT AN INFERIOR AND MID LOCATION. DURING THE PROCEDURE, THE PATIENT WAS IN ATRIAL PACED RHYTHM, AND THE LEFT ATRIAL PRESSURE WAS GREATER THAN 12 MMHG. THE PATIENT RECEIVED 13,000 UNITS OF HEPARIN, AND THE ACTIVATED CLOTTING TIME (ACT) WAS 314. THREE PARTIAL RECAPTURES OF THE DEVICE WERE REQUIRED DURING IMPLANTATION. A WIRE WAS NEVER PLACED IN THE LEFT ATRIAL APPENDAGE. AFTER THE PROCEDURE, 50 MG OF PROTAMINE WAS ADMINISTERED. SEVERAL WEEKS LATER, ON (B)(6) 2025, THE PATIENT PRESENTED WITH A PERICARDIAL EFFUSION. IMAGING SHOWED A SMALL TO MODERATE PERICARDIAL EFFUSION ON CT AND A MODERATE TO LARGE EFFUSION ON TTE, LOCALIZED TO THE RIGHT VENTRICLE. MEASUREMENTS WERE NOT NOTED IN THE ECHO REPORT. A PERICARDIOCENTESIS WAS PERFORMED, AND APPROXIMATELY 450- 500 CC OF BLOODY FLUID WAS REMOVED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, AND CARDIAC TAMPONADE WAS NOT PRESENT AT THE TIME OF PERICARDIOCENTESIS. THE PATIENT WAS HOSPITALIZED FOR A COUPLE OF DAY

  Patient problems: Pericardial Effusion

  MAUDE report 23726882 ↗
• InjuryDec 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. TRANSSEPTAL PUNCTURE WAS MID/SUPERIOR AND MID. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 331 SECONDS. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 12MMHG. DURING THE PROCEDURE THE OCCLUDER WAS PARTIALLY RE-CAPTURED THREE TIMES. THE OCCLUDER WAS IMPLANTED SLIGHTLY DEEPER THAN ANTICIPATED, HOWEVER THE DEVICE REMAINED STABLE WITH NO LEAKS. POST-PROCEDURE THE PATIENT COMPLAINED OF CONFUSION DURING THE NIGHT. THE FOLLOWING MORNING A 1CM PERICARDIAL EFFUSION WAS DISCOVERED IN THE LEFT ATRIAL APPENDAGE AND LEFT VENTRICLE. THE PATIENT WAS HELD FOR AN ADDITIONAL DAY FOR MONITORING AND THEN DISCHARGED WITH A PAUSE OF ORAL ANTI-COAGULANTS FOR ONE WEEK. NO INTERVENTION WAS REQUIRED. THE USER BELIEVED THE OCCLUDER CAUSED THE PERICARDIAL EFFUSION.

  Patient problems: Cognitive Changes; Pericardial Effusion

  MAUDE report 23694635 ↗
• InjuryDec 1, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM AMPLATZER AMULET WAS IMPLANTED IN THE PATIENT'S BODY USING A 14F AMPLATZER TORQVUE DELIVERY SHEATH . THE LANDING ZONE MEASUREMENTS USED TO DETERMINE DEVICE SIZE WERE 22 MM AT 0°, 18 MM AT 45°, 28 MM AT 90°, AND 28 MM AT 135°. DEVICE SIZING WAS BASED ON THE LARGEST LANDING ZONE MEASUREMENT PLUS 3 MM, AND THE OSTIUM MEASURED APPROXIMATELY 30¿32 MM. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS UTILIZED DURING THE PROCEDURE FOR IMAGING. THE DEVICE WAS IMPLANTED IN A ¿ROMAN HELMET¿ SHAPE, AND A TENSION TEST WAS PERFORMED. THE PATIENT¿S LEFT ATRIAL PRESSURE AT THE TIME OF THE PROCEDURE WAS 11 MMHG, AND NORMAL FLUID WAS ADMINISTERED DURING THE PROCEDURE. CLOSE CRITERIA WERE SATISFIED. ON (B)(6) 2025, DURING A 45-DAY FOLLOW-UP, TEE REVEALED THAT THE DEVICE HAD MIGRATED. THE DEVICE HAD SHIFTED WITHIN THE LANDING ZONE BUT REMAINED IN THE APPENDAGE; HOWEVER, THE DISC WAS NOT FULLY ENGAGED. THE IMPLANTER ATTRIBUTED THE MIGRATION TO A CALCIFIED APPENDAGE AND HYPER-CONTRACTILE ATRIAL TISSUE. THE INTERVENTION PERFORMED TO ADDRESS THE MIGRATION WAS PERCUTANEOUS RETRIEVAL. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED AND PATIENT IS REPORTED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687944 ↗
• MalfunctionNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM AMPLATZER AMULET WAS IMPLANTED. ON (B)(6) 2025, A LEAK WAS OBSERVED ON THE 31MM AMPLATZER AMULET OCCLUDER BY THE COUMANDIN RIDGE. THE LEAK WAS IDENTIFIED USING COMPUTED TOMOGRAPHY (CT) SCAN. THE MEASURED SIZE OF THE LEAK WAS APPROXIMATELY 10MM. NO INTERVENTIONS WERE PERFORMED TO ADDRESS THE LEAK AND THERE WAS NO ADDITIONAL DEVICE PLACEMENT, SURGICAL CORRECTION, OR MEDICATION ADJUSTMENT. THE PATIENT REMAINS ON DUAL ANTIPLATELET THERAPY (DAPT). THE PHYSICIAN OPTED TO MONITOR THE PATIENT WITHOUT FURTHER TREATMENT, AND ONGOING OBSERVATION IS CURRENTLY IN PLACE. 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 23651130 ↗
• InjuryNov 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM AMPLATZER AMULET WAS IMPLANTED IN THE PATIENT USING A 14F AMPLATZER AMULET SHEATH FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. THE LAA WAS NOTED TO HAVE A CAULIFLOWER-LIKE MORPHOLOGY WITH A DEPTH OF 20 MM, AND THE LANDING ZONE WAS MEASURED AT 26.8 × 21 MM. THE PROCEDURE WAS CHALLENGING, REQUIRING MULTIPLE DEPLOYMENT ATTEMPTS TO ACHIEVE OPTIMAL POSITIONING. IT WAS REPORTED THAT THERE WERE THREE PARTIAL RECAPTURES DURING THESE ATTEMPTS. INITIAL DEPLOYMENTS RESULTED IN PROTRUSION OF THE LOBE SHOULDER OR EXCESSIVE DEPTH, NECESSITATING RECAPTURE AND REPOSITIONING. ULTIMATELY, STABLE PLACEMENT WAS ACHIEVED ON THE FOURTH ATTEMPT AFTER ADJUSTING TO AN ANTERIOR AXIS. DURING THE PROCEDURE, LEFT ATRIAL PRESSURE WAS RECORDED AT 14 MMHG, AND HEPARIN WAS ADMINISTERED. THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) WAS 330, AND THE MOST RECENT INR PRIOR TO THE PROCEDURE WAS 1.8. POST-DEPLOYMENT IMAGING CONFIRMED CLOSURE AT 135° TEE, ALTHOUGH A SLIGHT GAP WAS NOTED AT THE LATERAL-SUPERIOR SIDE AT 0° TEE. IT WAS CONFIRMED THAT NO PERICARDIAL EFFUSION WAS OBSERVED AT ANY TIME DURING OR AFTER THE PROCEDURE, AND THE PATIENT LEFT THE OPERATING ROOM IN ST

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23622592 ↗
• DeathNov 7, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025 (FRIDAY), A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER AMULET DELIVERY SHEATH. THE SIZING OF THE DEVICE WAS DETERMINED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND ANGIOGRAPHY. THE LANDING ZONE MEASUREMENTS WERE 24-28MM. DURING PROCEDURE, THE V\ LEFT ATRIAL PRESSURE WAS 11-12MMHG AND FLUIDS WERE GIVEN. THERE WAS SOME DIFFICULTY WITH IMPLANTING THE DEVICE DUE TO THE ANGLE OF THE PUNCTURE WAS DIFFICULT DURING THE ANATOMY LESSON. THE OCCLUDER WAS SUCCESSFULLY IMPLANTED AFTER SATISFYING CLOSE CRITERIA AND TENSION TEST WAS PERFORMED. THE DEVICE COMPRESSION WAS NORMAL. ON (B)(6) 2025 (MONDAY), ON ULTRASOUND PROBE SHOWED THAT THE OCCLUDER WAS EMBOLIZED AND NOTED FREE IN THE LEFT ATRIUM. ON (B)(6) 2025 (TUESDAY), THE EXPLANATION PROCEDURE STARTED AND THE ANESTHESIA BEGAN, THE PATIENT'S BLOOD PRESSURE DROPPED SHARPLY, AND AFTER SEVERAL ATTEMPTS TO STABILIZE IT, THE PATIENT DIED. THE PHYSICIAN MENTIONED, PATIENT DEVELOPED SEVERE PNEUMONIA WITH SEVERE SEPSIS OVER THE WEEKEND. DURING THE NIGHT FROM MONDAY TO TUESDAY, HE DEVELOPED A HIGH FEVER. ULTIMATELY, THE PATIENT SUFFERED RIGHT HEART FAILURE. THE CAUS

  Patient problems: Fever; Low Blood Pressure/ Hypotension; Pneumonia; Sepsis

  MAUDE report 23496586 ↗
• InjuryNov 3, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE USING A 14F AMPLATZER AMULET DELIVERY SHEATH. THE SIZING OF THE DEVICE DETERMINED BASED ON 3D MEASUREMENTS INTRA OPERATIVE ABD FE0PS MEASUREMENTS AND MODELLING. THE LEFT ATRIAL PRESSURE WAS 22MMHG. THE AMULET WAS IMPLANTED AFTER MULTIPLE RECAPTURES DUE TO DIFFICULTY REDUCING POSTERIOR SHOULDER AND CLOSE CRITERIA WAS PERFORMED. A TENSION TEST WAS PERFORMED THREE TIMES AND THE DEVICE COMPRESSION WAS IN A TIRE SHAPE. APPROXIMATELY 20 MINUTES AFTER IMPLANT, THE PATIENT SUFFERED HYPOTENSION AND ECOTIC BEATS AND CONFIRMED THE AMULET WAS EMBOLIZED TO MITRAL VALVE. THE AMULET WAS SURGICALLY REMOVED VIA SURGICALLY AND LIGATION OF LAA. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 23458331 ↗