Amplatzer™ Amulet™ 9-ACP2-007-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00811806013466), received between Sep 16, 2021 and Sep 25, 2026 — classified as 6 deaths, 60 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (17 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 76 reports, in the reporter's own words as published by the FDA.

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

  It was reported that on (b)(6) 2026, a 18mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a Amulet Steerable Delivery Sheath. During the procedure, the left atrial pressure was 13mmHg. The Amulet was implanted after one partial recapture. Post recovery, the patient developed pericardial effusion and a pericardiocentesis was performed. The patient was reported stable.

  Patient problems: Pericardial Effusion

  MAUDE report 50897637 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6)2026, a 18mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the procedure. Three weeks post Amulet Implant, a pericardial effusion was noted in the patient. A pericardiocentesis was performed and drained fluid successfully. The patient was reported stable and discharged to home.

  Patient problems: Pericardial Effusion

  MAUDE report 50733515 ↗
• InjuryAug 5, 2026Patient Device Interaction Problem

  It was reported on (b)(6) 2026 a 20 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. Prior to the procedure, the patient was taking Aspirin and Ticagrelor. The 20 mm Amulet was determined to be too large and an 18 mm Amulet was then decided to be used for the procedure. During the procedure, the activating clotting time (ACT) was between 207 to 305 seconds. Heparin was administered. The device was implanted. On (b)(6) 2026, at the 45-day follow up, transesophageal echocardiogram confirmed a blob-like thrombus in the center of the device. The patient's medication was changed to address the thrombus. The patient status was stable.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50144184 ↗
• InjuryJul 30, 2026Migration or Expulsion of Device

  It was reported on 08 July 2026 a 18 mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using a 14F Amulet delivery sheath for a left atrial appendage (LAA) closure. The imaging modality used was transesophageal echocardiogram (TEE). The landing zone measurements were 14 mm at 0 degrees, 13 mm at 45 degrees, 13 mm at 90 degrees, and 16 mm at 135 degrees. The LAA was oval-shaped. The left atrial pressure was 12 mmHg and fluid was given. The device was repositioned once. No leak was detected. Slight compression was noted however, deemed acceptable by the physician. CLOSE criteria were satisfied. A tension test was performed. The device was implanted. After the device was released, TEE and X-ray confirmed the device embolized. Snaring of the device was attempted however, the device slipped and traveled to the chordae tendineae of the Mitral valve. The patient status was stable and transferred to another facility for heart surgery to remove the device. The device was explanted. The physician believes the embolization was caused by the LAA anatomy. The LAA was observed to be more elastic preventing the occluder from gaining a firm hold.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50087432 ↗
• MalfunctionJun 12, 2026Contamination /Decontamination Problem; Material Protrusion/Extrusion

  It was reported that on (b)(6) 2026, a 18mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for a procedure using a 12F Amulet Delivery Sheath. During the deployment Amulet 18mm in the left auricle appendage a ball position in a Amulet Delivery Sheath. After continue taking out the device lobe and disque and they see a thread in the left atrium with trans-oesophageal echocardiogram (TOE). They take back the Amulet and we see the thread coming out the device. They confirmed the sheath was reused. A new 18mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen and completed the procedure. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491889 ↗
• DeathMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 18MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING AN 14F AMPLATZER STEERABLE DELIVERY SHEATH. PRE-PROCEDURAL LANDING ZONE MEASUREMENTS USED TO DETERMINE DEVICE SIZING WERE REPORTED AS 19.3 MM AT 0°, 15.3 MM AT 45°, 12.6 MM AT 90°, AND 13.0 MM AT 135°. DEVICE SIZING WAS DETERMINED BY AVERAGING THE MEASUREMENTS AND UPSIZING FROM THE LARGEST DIMENSION; AN INITIAL 20 MM DEVICE WAS SELECTED BUT WAS NOTED TO BE OVERLY COMPRESSED, AND THEREFORE A SMALLER 18 MM DEVICE WAS IMPLANTED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS UTILIZED AS THE IMAGING MODALITY DURING THE PROCEDURE. THE IMPLANTER REPORTED THAT THE CLOSE CRITERIA WERE SATISFIED, AND THE IMPLANT APPEARED IDEAL ON FLUOROSCOPY. DURING THE PROCEDURE, INTERMITTENT EPISODES OF SINUS TACHYCARDIA WERE NOTED. A TENSION TEST WAS PERFORMED. THE LEFT ATRIAL PRESSURE WAS MEASURED AT 12 MMHG. THE PATIENT RECEIVED 500 ML OF FLUID PRIOR TO THE PROCEDURE AND AN ADDITIONAL 500 ML DURING THE PROCEDURE, AND LEFT ATRIAL PRESSURE WAS NOT REMEASURED FOLLOWING FLUID ADMINISTRATION. THE PROCEDURE INVOLVED A FULL RECAPTURE OF THE DEVICE, WITH ONE PARTIAL RECAPTURE INTO THE SHEATH, AND THE FINAL DEVICE CONFIGURATIO

  Patient problems: Bradycardia

  MAUDE report 25222879 ↗
• InjuryFeb 6, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER AMULET WAS IMPLANTED USING A 12F AMULET DELIVERY SHEATH. THE TRANSSEPTAL PUNCTURE LOCATION WAS DESCRIBED AS INFERIOR/MID. THE PATIENT WAS DESCRIBED AS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE, AND NO BASELINE PERICARDIAL EFFUSION WAS OBSERVED. THE MINIMUM MEASURED DISTANCE TO THE PULMONARY ARTERY WAS 2.92 MM. DURING THE PROCEDURE, THE ACT WAS RECORDED AS 368 SECONDS, AND THE LEFT ATRIAL PRESSURE WAS NOT MEASURED. A PIGTAIL WIRE WAS USED TO ACCESS THE APPENDAGE, AND THE SHEATH EXCHANGE WAS PERFORMED WITHIN THE LEFT ATRIAL APPENDAGE (LAA). ONE PARTIAL RECAPTURE OF THE DEVICE WAS CONDUCTED TO IMPROVE POSITIONING. A TENSION TEST WAS PERFORMED, AND THE CLOSE CRITERIA WERE REPORTED TO BE MET PRIOR TO FINAL DEPLOYMENT. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE, AND PROTAMINE OR ANOTHER REVERSAL AGENT WAS GIVEN DURING OR AFTER THE PROCEDURE. NO PERICARDIAL EFFUSION WAS NOTED AT DISCHARGE. THE PATIENT WAS DISCHARGED THE SAME DAY ON DUAL ANTIPLATELET THERAPY (DAPT) WITH A PLAN FOR ROUTINE FOLLOW-UP. APPROXIMATELY ONE MONTH LATER, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A GASTROINTESTINAL BLEED AND WAS SUBSEQUENTLY

  Patient problems: Cardiac Tamponade; Gastrointestinal Hemorrhage; Pericardial Effusion

  MAUDE report 24283890 ↗
• InjuryDec 15, 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 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A AMULET¿ STEERABLE DELIVERY SHEATH. THE APPENDAGE WAS VERY SHALLOW. DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS 14MMHG. AFTER MULTIPLE ATTEMPTS WITH DIFFERENT SIZES AND SHEATHS THE PROCEDURE WAS ABORTED. SHORTLY AFTERWARDS THE PATIENT DEVELOPED A CIRCUMFERENTIAL EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED WITH REMOVAL OF 800CC OF BLOOD. A CARDIAC TAMPONADE WAS ALSO NOTED. THE PHYSICIAN MENTIONED THE CAUSE OF PERICARDIAL EFFUSION WAS AMULET DEVICE. THE PATIENT WAS ADMITTED TO CORONARY CARE UNIT (CCU), BLOOD STOPPED DRAINING OVERNIGHT. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23809807 ↗
• InjuryDec 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL INFORMATION: (B)(6) - CATALYST IDE STUDY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE USING A 12F AMPLATZER AMULET DELIVERY SHEATH. THE LAA DEPTH WAS 15MM AND SHAPE OF THE APPENDAGE WAS CHICKEN WING. THE ATRIAL RHYTHM RECORDED AT START OF PROCEDURE WAS NON-SINUS RHYTHM (NSR). THE ACTIVATED CLOTTING LEVELS (ACT) WERE 337S AND HEPARIN WAS GIVEN. ON (B)(6) 2025, ON 3RD MONTH FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONDUCTED AND SHOWED THROMBUS. THE PATIENT WAS PUT BACK ON APIXABAN AND NEXT FOLLOW UP WAS SCHEDULED ON (B)(6) 2025. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23716533 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23660672 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 18MM AMPLATZER AMULET DEVICE WAS SELECTED FOR IMPLANTUSING AN UNKNOWN DELIVERY SYSTEM. WITHIN 24 HOURS POST-PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION, AND APPROXIMATELY 200 ML OF FLUID WAS DRAINED. THE PATIENT WAS STABILIZED, REMAINED HOSPITALIZED FOR AN ADDITIONAL NIGHT, AND WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2025.

  Patient problems: Pericardial Effusion

  MAUDE report 23381162 ↗
• InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) - CATALYST IDE STUDY, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6)2024, A 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE USING A 12F AMPLATZER AMULET DELIVERY SHEATH. THERE WAS 1MM PERICARDIAL EFFUSION WAS PRESENT PRIOR TO INTRODUCTION OF THE DELIVERY SYSTEM. THE LAA DEPTH WAS 24MM. DURING PROCEDURE, THE ATRIAL RHYTHM WAS ATRIAL FIBRILLATION (AF), 500ML VOLUME OF FLUIDS GIVEN AND HEPARIN WAS ADMINISTRATED. THE AMULET WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, THE PATIENT PRESENTED WITH DYSARTHRIA AND WEAKNESS OF THE HAND. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION.

  Patient problems: Movement Disorder

  MAUDE report 23171526 ↗
• InjurySep 26, 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 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. THE ANATOMY WAS COMPLEX, AND INITIALLY, A 20MM AMPLATZER AMULET DEVICE WAS CHOSEN BASED ON THE MEASUREMENTS, WHICH RANGED BETWEEN 15 AND 17MM FOR THE LANDING ZONE. DURING PROCEDURE, HEPARIN WAS ADMINISTERED. HOWEVER, THE POSITION AND CONFORMATION OF THE DEVICE WERE NOT ADEQUATE. THEY EVEN ATTEMPTED TO REPOSITION IT TWICE, BUT IT REMAINED UNSUITABLE FOR RELEASE (OUTSIDE THE CLOSE CRITERIA). THE 20MM AMULET REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. A NEW 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS THEN OPENED, AND IT MET THE RELEASE CRITERIA. THE DEVICE WAS SUCCESSFULLY DEPLOYED USING THE SAME DELIVERY SYSTEM. AFTER THE PROCEDURE, THE PATIENT WAS EXTUBATED AND PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN. AN ECHOCARDIOGRAM WAS PERFORMED, REVEALING A 5MM CIRCUMFERENTIAL PERICARDIAL EFFUSION. A CARDIAC TAMPONADE WAS ALSO PRESENT. THE PATIENT WAS KEPT UNDER OBSERVATION. AS THERE WAS NO PROGRESSION, PROTAMINE WAS ADMINISTERED, AND THE EFFUSION DECREASED. THE FOLLOWING DAY, THE PATIENT REMAINED STABL

  Patient problems: Angina; Cardiac Tamponade; Dyspnea; Pericardial Effusion

  MAUDE report 23154606 ↗
• MalfunctionSep 12, 2025Difficult to Fold, Unfold or Collapse; Difficult to Insert; Difficult to Fold, Unfold or Collapse; Difficult to Insert

  IT WAS REPORTED ON (B)(6) 2025 AN 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING THE PROCEDURE IT WAS NOTED THAT THE OCCLUDER COULD NOT BE ADVANCED FROM THE LOADER TO THE DELIVERY SHEATH. THE DEVICE LOADER WAS REMOVED FROM THE HUB OF THE SHEATH. THE OCCLUDER WAS REPLACED WITH A NEW 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. THE FIRST OCCLUDER WAS INSPECTED ON THE BACK TABLE AND WAS NOTED TO HAVE FORMED A COBRA SHAPE. 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 23041560 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Pneumothorax

  MAUDE report 23037421 ↗
• InjurySep 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE USING A 14F DELIVERY SYSTEM. THE SIZING WAS SELECTED BASED ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) MEASUREMENTS. THE LAA ANATOMY WAS A SHALLOW BROCCOLI. DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS 12MMHG. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE 300 SEC AND HEPARIN WAS ADMINISTERED. IT WAS A SINGLE DEPLOYMENT SINGLE DEVICE LAAO. THE AMULET WAS SUCCESSFULLY IMPLANTED. THAT NIGHT THE PATIENT GOT SHORT OF BREATH AND RECEIVED AT CHEST ECHOCARDIOGRAM (ECHO), WHICH SHOWED A PERICARDIAL EFFUSION. THE PATIENT UNDERWENT PERICARDIOCENTESIS. THE PHYSICIAN MENTIONED THE CAUSE OF EFFUSION WAS AMULET. THE PATIENT RECOVERED AND SUBSEQUENTLY DISCHARGED.

  Patient problems: Dyspnea; Pericardial Effusion

  MAUDE report 23037420 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 AN 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH TO TREAT A LEFT ATRIAL APPENDAGE (LAA). THE PATIENT HAD A PRE-EXISTING ATRIAL FIBRILLATION AT THE START OF THE PROCEDURE. THE PATIENT HAD A BROCCOLI-SHAPED LAA. THE LANDING ZONE WAS MEASURED WITH A MAXIMUM OF 18.1MM, A MINIMUM OF 10MM, AND A PERIMETER OF 16.1MM. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 13MMHG. TRANSSEPTAL PUNCTURE WAS ATTEMPTED INFERIOR AND POSTERIOR, HOWEVER DUE TO FRAIL TISSUE, THE TENTING PHASE RESULTED IN AN UNINTENDED PERFORATION INTO THE LEFT ATRIUM WITHOUT ELECTROCAUTERY. FIVE THOUSAND UNITS OF HEPARIN WERE ADMINISTERED. DURING THE FIRST DEPLOYMENT ATTEMPT CLOSE CRITERIA WERE MET, THE DISC OF THE OCCLUDER WAS POSITIONED DISTALLY TO THE PULMONARY VEIN (PV) RIDGE. DURING THE TENSION TEST THE DISC WAS REPOSITIONED ON THE PV RIDGE. WHEN THE DELIVERY SHEATH WAS BROUGHT CLOSE TO THE OCCLUDER FOR RELEASE, THE DISC FELL OF THE PV RIDGE TWO OR THREE TIMES. THE DELIVERY CABLE WAS PULLED TO REPOSITION THE DISC ONTO THE RIDGE REPEATEDLY. THE OCCLUDER WAS RELEASED FROM THE CABLE WHILE POSITIONED ON THE PV RIDGE.

  Patient problems: Pericardial Effusion

  MAUDE report 23006090 ↗
• MalfunctionAug 26, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER AMULET DELIVERY SHEATH. WHILE CONSIDERING SLIGHTLY SMALLER PRE-MEASURED VALUES AND CONCERNS ABOUT THE DISTANCE TO THE PULMONARY ARTERY (PA) THEY DECIDED TO USE A 18MM AMULET. THE LANDING ZONE MEASUREMENTS WERE 18.1MM (0°), 18.5MM (45°), 13.3MM (90°), 16MM (135°); 3D: 17.9 × 16.2MM. THE PATIENT¿S HEART RHYTHM DURING THE PROCEDURE WAS SINUS RHYTHM, LEFT ATRIAL PRESSURE WAS 13 MMHG AND STANDARD FLUID ADMINISTRATION WAS PERFORMED, BUT EXACT VOLUME IS UNKNOWN. THE IMAGE MODALITY USED IN THE PROCEDURE WAS TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND ANGIOGRAPHY (ANGIO). DURING THE FIRST DISC DEPLOYMENT, THE LOBE WAS NOT FIXED AND MOVED PROXIMALLY, SO PARTIAL RECAPTURE AND REDEPLOYMENT WERE PERFORMED. THE SHAPE OF THE DEVICE AT THE TIME OF IMPLANTATION WAS TIRE-SHAPE. AT THE TIME OF DEVICE RELEASE, THE CLOSE CRITERIA WERE MET, A TENSION TEST WAS PERFORMED AND EE CONFIRMED DEVICE COMPRESSION WAS IN A ELLIPTICAL SHAPE. THERE WAS NO PERI-DEVICE LEAK (PDL) WAS NOTED. AT THE 45-DAY FOLLOW-UP, A CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CCTA) WAS PERFORMED, WHICH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898783 ↗
• InjuryAug 26, 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 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS IN THE TARGETED ZONE WAS >= 250S. THE AMULET WAS SUCCESSFULLY IMPLANTED WITHOUT ANY DIFFICULTIES. AFTER THE PROCEDURE, THE PATIENT REPORTED HAVING A MILD PERICARDITIS. THE PATIENT PRESCRIBED WITH COLCHICINE AND REPORTED STABLE.

  Patient problems: Pericarditis

  MAUDE report 22898595 ↗
• DeathJul 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 18MM AMPLATZER AMULET WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER AMULET DELIVERY SHEATH. NO PERICARDIAL EFFUSION WAS OBSERVED PRIOR TO PROCEDURE. THE TRANSSEPTAL PUNCTURE WAS MID ANTERO POSTERIOR AND INFERIOR. THE AMULET WAS IMPLANTED UPON THE FIRST ATTEMPT AND WITH "MINIMUM OF MANIPULATIONS INSIDE THE LEFT APPENDAGE." CLOSE CRITERIA WAS MET AND STABILITY TEST WAS PERFORMED AND PASSED. POST-IMPLANT TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND NEGATIVE FOR PERICARDIAL EFFUSION. APPROXIMATELY ONE HOUR POST-PROCEDURE, "THE PATIENT COLLAPSED" WHILE IN THE INTENSIVE CARE UNIT (ICU). TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED, WHICH SHOWED A "MASSIVE" LOCALIZED POSTERIOR LARGE PERICARDIAL EFFUSION; CARDIAC TAMPONADE WAS CONFIRMED PRESENT. THE CAUSE OF THE EFFUSION WAS THOUGHT TO BE EITHER DUE TO THE TRANSSEPTAL PUNCTURE OR TO AMULET MANIPULATION; "NO CLEAR ANSWER" WAS PROVIDED. THE PERICARDIAL SPACE WAS DRAINED. DESPITE THIS AND RESUSCITATION, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS "MASSIVE TAMPONADE."

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 22533668 ↗
• InjuryJun 20, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025 AN 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT TO TREAT A LEFT ATRIAL APPENDAGE (LAA). DEVICE SIZING WAS DETERMINED BASED ON LEFT ATRIAL PRESSURE AND ECHOCARDIOGRAM (ECHO) AND ANGIOGRAPHY (ANGIO). ECHO AND ANGIO WERE USED DURING THE PROCEDURE. THE PATIENT'S LANDING ZONE ON THE SHORT AXIS WAS 11MM ON THE SHORT AXIS AND 15MM ON THE LONG AXIS. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 11 MMHG. DURING THE PROCEDURE THE OCCLUDER WAS PARTIALLY RE-CAPTURED TWICE. A TENSION TEST WAS PERFORMED. CLOSE CRITERIA WERE MET. THE OCCLUDER WAS IMPLANTED. ON (B)(6) 2025 DURING A FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IT WAS OBSERVED THAT THE OCCLUDER WAS PARTIALLY ANCHORED ON THE VENTRICLE. THE PATIENT WAS HOSPITALIZED AND TRANSFERRED TO A DIFFERENT CLINIC FOR CARDIAC SURGERY. THE PATIENT STATUS AT THIS POINT WAS STABLE WITH NO BLOOD PRESSURE FLUCTUATIONS. ON (B)(6) 2025, AT THE BEGINNING OF THE CARDIAC SURGERY IT WAS NOTED THAT THE OCCLUDER WAS ACTUALLY IN THE ABDOMINAL AORTA. THE PATIENT WAS AWAKENED AND ADMITTED TO THE CARDIAC INTENSIVE CARE UNIT (CICU) WHILE AWAITING PERCUTANEOUS RETRIEVAL IN THE HEMODYNAMICS LAB. AT THE TIME

  Patient problems: Syncope/Fainting

  MAUDE report 22299716 ↗
• DeathJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 AN 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT HAD A PRE-EXISTING TRACE EFFUSION AT THE START OF THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS INFERIOR AND MID. THE PATIENT HAD A HYPERCONTRACTILE APPENDAGE. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 13 MMHG. CLOSE CRITERIA WERE MET AND THE OCCLUDER WAS IMPLANTED. THE TRIVIAL EFFUSION WAS UNCHANGED. ON (B)(6) 2025 THE PATIENT RETURNED TO THE HOSPITAL WITH DIZZINESS AND CHEST PAIN AND BECAME HYPOTENSIVE. A SURFACE ECHOCARDIOGRAM REVEALED A MODERATE, CIRCUMFERENTIAL PERICARDIAL EFFUSION WITH A RIGHT VENTRICLE CHAMBER COLLAPSE. THE EFFUSION DEVELOPED INTO A CARDIAC TAMPONADE. THE PATIENT DECOMPENSATED WITH ST CHANGES AND BECAME HEMODYNAMICALLY UNSTABLE. THE PATIENT WENT INTO CARDIAC ARREST AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. A PERICARDIOCENTESIS WAS PERFORMED WHILE THE PATIENT WAS CODING AND 150CC OF LIQUID WAS REMOVED. THE PATIENT PASSED AWAY ON (B)(6) 2025. THE CAUSE OF DEATH WAS THE PERICARDIAL EFFUSION. THE USER BELIEVED THE PERICARDIAL EFFUSION WAS DUE TO THE OCCLUDER.

  Patient problems: Angina; Cardiac Arrest; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Movement Disorder; Non specific EKG/ECG Changes; Pericardial Effusion

  MAUDE report 22186222 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, AN 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SUCCESSFULLY IMPLANTED IN A PATIENT USING A 12F AMPLATZER AMULET DELIVERY SHEATH AS PART OF A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE. THE PATIENT WAS ADMINISTERED 4000 UI OF HEPARIN AND HAD A NOTED ACTIVATED CLOTTING TIME (ACT) LEVEL ABOVE 250 SECONDS. THE PATIENT WAS IN ATRIAL FIBRILLATION AT THE TIME OF PROCEDURE. THE TRANSEPTAL PUNCTURE WAS INFERIOR-POSTERIOR. THERE WAS NO DIFFICULTY EXPERIENCED IMPLANTING THE AMULET. THERE WAS NOT MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THE PATIENT WAS ADMINISTERED 2500 UI OF PROTAMINE AFTER PROCEDURE. IT WAS NOTED 2 HOURS POST-PROCEDURE, ON ECHOCARDIOGRAPHY THAT THE PATIENT DEVELOPED A 10MM CIRCUMFERENTIAL PERICARDIAL EFFUSION. THE PATIENT DID DEVELOP CARDIAC TAMPONADE. A PERICARDIAL EFFUSION WAS NOT NOTED PRIOR TO PROCEDURE. WITH A SYRINGE AND A PIGTAIL, BLOOD SUCKED OUT. THE PATIENT WAS NO TAKING AN ANTICOAGULANT OR ANTIPLATELET MEDICATION PRIOR TO PROCEDURE. THE PATIENT WAS TAKING 250 MG OF INTRAVENOUS AS

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 22118777 ↗
• InjuryJan 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 , A 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS 12MMHG AND A BASELINE TRIVIAL PERICARDIAL EFFUSION WAS NOTED ON THE DAY OF PROCEDURE. THE AMULET WAS SUCCESSFULLY IMPLANTED. TWO AND HALF MONTHS AFTER THE PROCEDURE, THE PATIENT PASSED OUT AND PRESENTED IN THE HOSPITAL. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND CIRCUMFERENTIAL 2CM PERICARDIAL EFFUSION WAS NOTED. A CARDIAC TAMPONADE WAS ALSO NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND 350 ML OF OLD BLOOD WAS DRAINED. THE PHYSICIAN MENTIONED THE CAUSE OF EFFUSION WAS AMULET DEVICE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Syncope/Fainting

  MAUDE report 21060166 ↗
• MalfunctionDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2024 , A 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE USING AN UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, WHEN THE PHYSICIAN TRIED TO DISCONNECT THE HEMOSTASIS VALVE TO THE AMULET LOADER, PART OF THE LOADER BROKE INTO THE Y-CONNECT. THEY REMOVED THE HEMOSTASIS VALVE & LOADER FROM THE CABLE AND CONNECTED ANOTHER HEMOSTASIS VALVE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS WITHOUT ANY ISSUES AND PATIENT STAYED STABLE THE WHOLE TIME. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20979870 ↗