Amplatzer™ Amulet™ 9-ACP2-007-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00811806013473), received between Dec 2, 2021 and Sep 18, 2026 — classified as 15 deaths, 104 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (29 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 130 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that (b)(6) 2026, a 20mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a 12F Amplatzer Amulet Delivery Sheath. The patient had difficult anatomy and required a 2nd transseptal puncture. The septum was difficult to visualize by transesophageal echocardiogram (TEE). During procedure, the patient's activated clotting time (ACT) levels were 340s & 223s. The left atrial pressure at time of procedure was 3mmHG, a 500ml bolus was given to the patient. The Amulet was implanted and released in 5 mins including 2 partial recaptures. The patient was kept overnight in precaution. A small effusion was noted the morning following the implant. The patient remains stable and did complain of chest pain. They were prescribed colchicine and remain admitted for further monitoring. The patient is stable and the device remains in good implanted position.

  Patient problems: Angina; Pericardial Effusion

  MAUDE report 50817723 ↗
• InjurySep 18, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 20mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen in extremely complex anatomy previously failed by non-Abbott device. The device was partially recaptured two times and ultimately deployed and released in 15 minutes. The patient was kept overnight out of precaution due to implanter experience and by recommendation of the proctoring physician. Next morning, echocardiogram (ECHO) noted that the device no longer remained in its implanted position. A chest x-ray was ordered to locate its location, it dislodged from its implanted location and was identified in the descending aorta. The physician on service and rounding the hospital consulted with vascular surgery and deferred to surgery to retrieve the embolized device. On (b)(6) 2026, the device was successfully retrieved and the patient remained stable. The patient is stable and recovering in the hospital.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817178 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on 05 August 2026 a 20mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using a 14F Amplatzer Amulet Delivery Sheath. The procedure was concomitant with the Volt catheter. The landing zone was measured under the following degree views: 15mm at 0 degrees, 13mm at 45 degrees, 14mm at 90 degrees, and 14mm at 135 degrees. Transesophageal echocardiography (TEE) was used during the procedure. Transseptal puncture was inferior and mid. A tension test was performed. CLOSE criteria were met. The device was implanted. The patient was stable and discharged. On an unknown date the patient was found unresponsive in the bathtub. Cardiopulmonary resuscitation (CPR) was performed; however the patient passed away.

  Patient problems: Syncope/Fainting

  MAUDE report 50620745 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 20MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING AN 12 F AMPLATZER TORQVUE DELIVERY SYSTEM. A SMALL BASELINE PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE START OF THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED AT AN INFERIOR MID LOCATION, AND THE PATIENT WAS IN NORMAL SINUS RHYTHM AT THE TIME OF THE PROCEDURE. HEPARIN WAS ADMINISTERED, ACHIEVING AN ACTIVATED CLOTTING TIME (ACT) OF 320 SECONDS, WITH LEFT ATRIAL PRESSURE REPORTED TO BE GREATER THAN 12 MMHG. DURING DEVICE DEPLOYMENT, THERE WAS DIFFICULTY WITH IMPLANTATION REQUIRING MULTIPLE MANIPULATIONS, INCLUDING THREE PARTIAL RECAPTURES AND ONE FULL RECAPTURE OF THE DEVICE INTO THE DELIVERY SYSTEM, AFTER WHICH THE DEVICE AND DELIVERY SYSTEM WERE EXCHANGED. NO WIRE WAS PLACED IN THE LEFT ATRIAL APPENDAGE, AND THERE WERE NO MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES, WITH NO WIRE POSITIONED IN THE UPPER OR LOWER PULMONARY VEINS. DURING THE PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION, AND CARDIAC TAMPONADE WAS CONCLUDED TO BE PRESENT BY THE PHYSICIAN(S). PERICARDIOCENTESIS WAS PERFORMED, AND A REVERSAL AGENT (PROTAMINE) WAS ADMINISTERED. SUBSEQUENTLY, THE PATIENT WAS TRANSFERRED T

  Patient problems: Pericardial Effusion

  MAUDE report 24680182 ↗
• InjuryMar 16, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 73-YEAR-OLD MALE PATIENT WITH PAROXYSMAL ATRIAL FIBRILLATION UNDERWENT A CONCOMITANT LEFT ATRIAL CLOSURE AND PULMONARY VEIN ISOLATION PROCEDURE, DURING WHICH A 20 MM AMPLATZER AMULET DEVICE WAS IMPLANTED USING A 12F AMULET DELIVERY SHEATH. THE PATIENT WAS IN SINUS RHYTHM AT THE TIME OF THE PROCEDURE AND HAD BEEN RECEIVING ORAL ANTICOAGULATION THERAPY PRIOR TO THE INTERVENTION, WITH THE LAST DOSE TAKEN THE EVENING BEFORE THE PROCEDURE. A LOADING DOSE OF ACETYLSALICYLIC ACID (ASA) WAS ADMINISTERED ON THE MORNING OF THE PROCEDURE, AND ORAL ANTICOAGULATION WAS DISCONTINUED THE EVENING OF THE PROCEDURE. A TRANSSEPTAL PUNCTURE WAS PERFORMED IN AN INFERIOR-MID LOCATION AS PART OF THE COMBINED PROCEDURE. MULTIPLE WIRE AND DELIVERY SHEATH EXCHANGES WERE REQUIRED, WITH WIRE POSITIONING IN THE UPPER PULMONARY VEIN, DUE TO A SMALL LEFT ATRIAL APPENDAGE WITH COMPLEX ANATOMY. DURING THE PROCEDURE, HEPARIN WAS ADMINISTERED AT A TOTAL DOSE OF 18,000 IU, WITH ACTIVATED CLOTTING TIME VALUES RANGING BETWEEN 298 AND 357 SECONDS, AND THE LEFT ATRIAL PRESSURE WAS RECORDED BETWEEN 10 AND 14 MMHG. FOLLOWING COMPLETION OF THE PROCEDURE, THE PATIENT LATER REPORTED THOR

  Patient problems: Pain; Pericardial Effusion

  MAUDE report 24612641 ↗
• InjuryFeb 24, 2026Patient Device Interaction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434258 ↗
• MalfunctionJan 23, 2026Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 12F AMPLATZER TREVISIO DELIVERY SYSTEM. DURING THE DEVICE PREPARATION, AIR WAS OBSERVED INSIDE THE LINING OF THE LOADER, WHICH INITIALLY CAUSED CONCERN. AFTER EXTENSIVE EVALUATION, FURTHER ASSESSMENT CONFIRMED THAT THE AIR BUBBLE WAS LOCATED WITHIN THE LUMEN OF THE LOADER AND NOT WITHIN THE LOADER MATERIAL ITSELF. ONCE THIS DETERMINATION WAS MADE, THE PROCEDURE CONTINUED WITHOUT INTERRUPTION. THE IMPLANTATION WAS COMPLETED AS PLANNED WITHOUT ANY COMPLICATIONS. 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 24169046 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. FOLLOWING THE PROCEDURE, THE PHYSICIAN REPORTED OBSERVING TWO LATE EFFUSIONS. THE PATIENTS WERE REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN INDICATED THAT THE EFFUSIONS MIGHT BE RELATED TO THE PATIENTS BEING PLACED ON ELIQUIS POST-PROCEDURE, WHICH IS A PRACTICE HE TYPICALLY FOLLOWS FOR ABLATION PATIENTS.

  Patient problems: Pericardial Effusion

  MAUDE report 24037903 ↗
• MalfunctionJan 12, 2026Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT (B)(6) 2025, A 16MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT. DUE TO UNSATISFACTORY CLOSE ASSESSMENT FINDINGS, THE DEVICE WAS RESIZED, AND A 20 MM AMPLATZER AMULET WAS SUBSEQUENTLY IMPLANTED USING A 12F AMULET DELIVERY SHEATH. FOLLOWING THE PROCEDURE, A PREVIOUSLY UNIDENTIFIED FILAMENT WAS OBSERVED EXTENDING FROM THE LEFT PULMONARY ARTERY TO THE AORTA. AT FOLLOW-UP, THE FILAMENT REMAINS PRESENT AND ITS NATURE IS STILL UNDETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036138 ↗
• MalfunctionJan 5, 2026Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMULET DELIVERY SHEATH. THE FLUSHING PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO VISIBLE DAMAGE OBSERVED ON THE PACKAGE PRIOR TO OPENING. DURING THE PROCEDURE, WHILE DOING THE CONTRAST MEDIUM INJECTION, THE THREE-WAY STOPCOCK OF THE AMULET DEVICE WAS REPORTED TO BE BROKEN. THERE WERE NO MULTIPLE RECAPTURES OR MANIPULATIONS OF THE DEVICE DURING THE PROCEDURE AND NO LEAK WAS DETECTED. THE PROCEDURE WAS COMPLETED USING A 22MM AMPLATZER AMULET. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967758 ↗
• MalfunctionDec 24, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 12F AMULET DELIVERY SHEATH. DURING THE PROCEDURE, IT WAS NOTED THAT AS THE DEVICE WENT IN, A SMALL THREAD LIKE OR A FILAMENT LIKE STRUCTURE WAS OBSERVED ON THE IMAGING COMING OUT OF THE LOBE WHILE ON ICE. THE DEVICE WAS NOT COMPLETELY DEPLOYED AND WAS NEVER RELEASED FROM THE CABLE. WHEN THE OBSERVATION WAS MADE, THE DEVICE WAS MANIPULATED BY RECAPTURING IT AND WAS FULLY RETRACTED INTO THE DELIVERY SYSTEM. THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) WAS GREATER THAN 300. THE PROCEDURE WAS THEN COMPLETED USING A NEW 22 MM AMPLATZER AMULET DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889296 ↗
• MalfunctionDec 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING 12F AMULET DELIVERY SYSTEM. DURING THE PROCEDURE , WHILE IMPLANTING , IT WAS OBSERVED THAT DURING CONNECTION BETWEEN THE DELIVERY SYSTEM AND THE AMULET OCCLUDER WHILE TIGHTENING THE THE ROTATING LUER, THE DELIVERY SYSTEM BROKE LEAVING A PORTION OF ITS CONNECTION ATTACHED TO THE DEVICE'S LOADER. NO PORTION OF THE BROKEN COMPONENT WAS RETAINED INSIDE THE PATIENT OR SYSTEM. A NEW DEVICE AND DELIVERY SYSTEM WAS CHOSEN AND THE PROCEDURE WAS COMPLETED. 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 23833283 ↗
• InjuryDec 17, 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 22 MM AMPLATZER AMULET DEVICE WAS DEPLOYED FIRST, FOLLOWED BY A 20 MM DEVICE, AND THEN A 25 MM DEVICE, USING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM. PRIOR TO THE PROCEDURE IT WAS CLARIFIED THAT THE PATIENT DID HAVE AN EXISTING SMALL BASELINE EFFUSION, WHICH THE ECHO PHYSICIAN NOTED TO HAVE INCREASED DURING THE PROCEDURE. A TRANSSEPTAL PUNCTURE WAS PERFORMED AT AN INFERIOR/MID POSITION TO ACCESS THE LEFT ATRIUM. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS USED THROUGHOUT THE PROCEDURE FOR IMAGING GUIDANCE. DEVICE SIZING WAS DETERMINED BASED ON LANDING ZONE MEASUREMENTS. THE FIRST DEVICE ATTEMPTED WAS A 22 MM AMULET DEVICE DEPLOYED THROUGH A 14F AMPLATZER TORQVUE DELIVERY SYSTEM. AFTER DEPLOYMENT, THE 22 MM DEVICE WAS FOUND TO BE UNSTABLE ON THE MITRAL SIDE, LEADING TO ITS RECAPTURE AND REMOVAL. THE HEAVY PECTINATE MUSCLE WITHIN THE APPENDAGE CONTRIBUTED TO DIFFICULTY IN MAINTAINING PROPER DEVICE ORIENTATION, NECESSITATING RECAPTURES. A SECOND ATTEMPT WAS MADE USING A 20 MM DEVICE, WITH AN EFFORT TO IMPLANT IT DEEPER INTO THE APPENDAGE. HOWEVER, THE HEAVY PECTINATE AGAIN PUSHED THE DEVICE OFF ORIENTATION, PREVENTING ADEQUATE STABILITY AND CONFIR

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23825007 ↗
• InjuryDec 16, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824959 ↗
• InjuryDec 15, 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 WAS IMPLANTED USING A 14F AMPLATZER TORQVUE SHEATH . THE TRANSSEPTAL PUNCTURE WAS PERFORMED AT AN INFERIOR MID LOCATION. FOLLOWING THE PROCEDURE, A PERICARDIAL EFFUSION WAS OBSERVED, NOTED POST-PROCEDURALLY WHEN THE DEVICE WAS DEPLOYED AND THE PATIENT WAS STILL ON THE TABLE. THE PATIENT SUBSEQUENTLY EXPERIENCED CARDIAC TAMPONADE. THE TRANSEPTAL SYSTEM AND WIRE WERE IN THE LEFT ATRIAL APPENDAGE (LAA), WITH REPEATED WIRE MANIPULATIONS IN THE APPENDAGE BEFORE MOVING TO THE UPPER PULMONARY VEIN. THE LEFT ATRIAL PRESSURE AT THE TIME OF THE PROCEDURE WAS GREATER THAN 12MMHG. A WIRE WAS PLACED IN THE LAA DURING TRANSEPTAL ACCESS, WITH MULTIPLE WIRE MANIPULATIONS AS THE PHYSICIAN ATTEMPTED TO ENTER THE VEIN. THE PATIENT WAS STABILIZED AND TRANSFERRED OUT OF THE OPERATING ROOM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23804773 ↗
• InjuryDec 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  N/A.

  Patient problems: Angina; Bradycardia; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23762631 ↗
• 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 20MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM. THE TRANSSEPTAL PUNCTURE LOCATION WAS INFERIOR ANTERIOR. DURING THE PROCEDURE, THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) WAS 258, AND HEPARIN WAS ADMINISTERED. PROTAMINE WAS GIVEN, BUT NOT IMMEDIATELY AFTER THE PROCEDURE; THERE WAS A DELAY. THE PATIENT WAS IN NORMAL SINUS RHYTHM (NSR) AT THE TIME OF THE PROCEDURE. THERE WERE MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES, AND THE WIRE POSITION WAS IN THE UPPER OR LOWER PULMONARY VEIN. THE LEFT ATRIAL PRESSURE AT THE TIME OF THE PROCEDURE WAS 17 MMHG. A WIRE WAS PLACED IN THE LEFT ATRIAL APPENDAGE. THERE WAS NO DIFFICULTY IMPLANTING THE DEVICE, SUCH AS MULTIPLE MANIPULATIONS. ONE HOUR POST-PROCEDURE, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION AND PERICARDIOCENTESIS WAS PERFORMED. THE USER DOES NOT BELIEVE THE ABBOTT DEVICE CAUSED THE PERICARDIAL EFFUSION; THEY BELIEVE IT WAS DUE TO THE TRANSSEPTAL PUNCTURE. THE PHYSICIAN(S) CONCLUDED THAT CARDIAC TAMPONADE WAS PRESENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATI

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23729502 ↗
• InjuryNov 26, 2025Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 20MM AMPLATZER AMULET DEVICE WAS SELECTED FOR IMPLANTATION USING A 14F AMPLATZER AMULET DELIVERY SHEATH. THE TRANSSEPTAL PUNCTURE WAS PERFORMED IN AN INFERIOR, POSTERIOR LOCATION. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS UTILIZED TO ASSESS THE MORPHOLOGY AND DIMENSIONS OF THE LEFT ATRIAL APPENDAGE (LAA), WHICH WAS FOUND TO BE WINDSOCK-SHAPED. AT 135°, TWO-DIMENSIONAL TEE REVEALED A RELATIVELY CIRCULAR LANDING ZONE MEASURING 18.8 × 15.2 MM. THREE-DIMENSIONAL TEE WAS EMPLOYED TO MEASURE THE PERIMETER OF THE LANDING ZONE, YIELDING AN AVERAGE DIAMETER OF 17.8 MM. BASED ON THESE FINDINGS, AN ADDITIONAL 3 MM WAS ADDED TO THE MEASURED DIAMETER, AND THE SHORT-AXIS DIMENSION WAS CONSIDERED IN SELECTING THE APPROPRIATE DEVICE SIZE. DURING THE INITIAL DEPLOYMENT, THE LOBE OF THE DEVICE WAS FULLY EXPANDED FROM A BALL SHAPE TO A TRIANGULAR CONFIGURATION. HOWEVER, POSTERIOR DISPLACEMENT OF THE LOBE TOWARD THE LEFT ATRIUM WAS OBSERVED ON 135° TEE IMAGING. A PARTIAL RECAPTURE WAS PERFORMED, AND THE SHEATH TIP WAS ROTATED SLIGHTLY COUNTERCLOCKWISE TO OPTIMIZE POSITIONING. THE LOBE WAS THEN REDEPLOYED IN A MORE STABLE LOCATION. THE DISC WAS SUBSEQUENTLY DEPLO

  Patient problems: Cardiac Tamponade; Pericardial Effusion; Pericarditis; Tachycardia

  MAUDE report 23660783 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMULET DELIVERY SHEATH. THE PATIENT HAD A PRE-EXISTING ATRIAL FIBRILLATION AND LUNG INFECTION. TRANSSEPTAL PUNCTURE WAS INFERIOR AND MID. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS APPROXIMATELY 250 SECONDS. HEPARIN WAS ADMINISTERED. DURING THE PROCEDURE THE OCCLUDER WAS PARTIALLY RE-CAPTURED TWICE. UPON CLOSING THE LEFT ATRIAL APPENDAGE, THE PATIENT PRESENTED WITH AN 8MM MODERATE PERICARDIAL EFFUSION. THE PATIENT HAD PROLONGED HOSPITALIZATION FOR MONITORING. APPROXIMATELY A WEEK FROM THE PROCEDURE THE PATIENT DEVELOPED A PULMONARY INFECTION. THE INFECTION WAS TREATED. THE PATIENT STATUS WAS STABLE. THE USER BELIEVED THE PERICARDIAL EFFUSION WAS DUE TO THE PATIENT'S PRE-EXISTING LUNG CONDITION.

  Patient problems: Pericardial Effusion; Respiratory Tract Infection

  MAUDE report 23659259 ↗
• InjuryNov 7, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; 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 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING PROCEDURE, THE DOC'S SHEATH CAME OUT OF THE APPENDAGE AND ACCIDENTALLY WENT ACROSS MITRAL VALVE WHILE IN BALL, AND HIT THE MITRAL ANNULUS MULTIPLE TIMES. THE FIRST DEPLOYMENT WAS SO DEEP THAT IT WASN'T SEEN WELL ON IMAGING. THERE WERE MULTIPLE REDEPLOYMENTS AND A NEW 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN WITH THE SAME DELIVERY SYSTEM. DURING THE FIRST DEPLOYMENT OF THE SECOND DEVICE, WHEN THE DISC WAS DEPLOYED THE LOBE JUMPED UP MORE PROXIMALLY. THE DOC REDEPLOYED TWICE AND THEY LEFT A GOOD IMPLANT. AFTER RELEASE, A 16MM CIRCUMFERENTIAL, BUT MORE LOCALIZED POSTERIOR PERICARDIAL EFFUSION WAS NOTED THAT GREW BIGGER. A CARDIAC TAMPONADE WAS ALSO NOTED. A PERICARDIOCENTESIS WAS PERFORMED AND REMOVED 458CCS OF BLOOD. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23497988 ↗
• InjuryOct 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 12F AMULET DELIVERY SHEATH TO TREAT A LEFT ATRIAL APPENDAGE (LAA). THE PATIENT HAD A PRE-EXISTING ATRIAL FIBRILLATION. IT WAS NOTED THAT THERE WAS LIMITED VISUALIZATION WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). TRANSSEPTAL PUNCTURE WAS POSTERIOR AND MEDIAL. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 220-250 SECONDS. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 10MMHG. DURING THE PROCEDURE THE OCCLUDER WAS PARTIALLY RE-CAPTURE TWICE. THERE WAS DIFFICULTY ASSESSING DEPLOYMENT OF THE OCCLUDER'S LOBE. THE OCCLUDER WAS MANIPULATED IN A BALL CONFIGURATION IN AN ATTEMPT TO PROPERLY ORIENT IT WITHIN THE LANDING ZONE, HOWEVER THE LOBE COULD NOT BE VISUALIZED. THE PATIENT THEN PRESENTED WITH A CIRCUMFERENTIAL PERICARDIAL EFFUSION WAS NOTED ON ECHOCARDIOGRAM. THE EFFUSION DEVELOPED INTO A CARDIAC TAMPONADE. THE PROCEDURE WAS SUSPENDED, AND THE OCCLUDER WAS NOT IMPLANTED. AN INJURY WAS NOTED AT THE LEFT ATRIOVENTRICULAR JUNCTION. THE LEFT ATRIOVENTRICULAR JUNCTION WAS SURGICALLY REPAIRED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR MONITORING. THE PA

  Patient problems: Cardiac Tamponade; Perforation; Pericardial Effusion

  MAUDE report 23359898 ↗
• InjuryOct 15, 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 A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING THE PROCEDURE, THE ACTIVATED CLOTTING TIME (ACT) LEVELS WERE ABOVE 250S AND 9000 UNITS OF HEPARIN WAS ADMINISTERED. THE LEFT ATRIAL PRESSURE AT TIME OF PROCEDURE WAS 12MMHG. THE AMULET WAS SUCCESSFULLY IMPLANTED. ZERO RECAPTURES WERE PERFORMED, TENSION TEST PERFORMED FOR STABILITY AND THE DEVICE MET ALL CLOSE CRITERIA. THE PATIENT WAS REPORTED STABLE AT ALL TIMES PRE, DURING AND POST PROCEDURE. THE PATIENT WAS SENT TO POST ANESTHESIA CARE UNIT (PACU) FOR POST ANESTHESIA RECOVERY. THE PATIENT WENT INTO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR)AND WAS GIVEN ESMOLOL. THE PATIENT BECAME BRADYCARDIC AND CHEST COMPRESSIONS STARTED. A PERICARDIAL EFFUSION NOTED ON BEDSIDE ECHOCARDIOGRAM, BLOOD AND PLATELETS GIVEN AND ATTEMPTED TO DRAIN THE EFFUSION. A CARDIAC TAMPONADE WAS ALSO PRESENT. IT WAS UNABLE TO FULLY DRAIN PERICARDIUM DUE TO BLOOD CLOTTING OFF, ONLY 40ML REMOVED. THE PATIENT TAKEN TO CARDIOVASCULAR SURGERY (CV) SURGERY TO FURTHER DRAIN CLOT. THE USER BE

  Patient problems: Atrial Fibrillation; Bradycardia; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23297043 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED IN THE PATIENT USING A 12F AMPLATZER AMULET DELIVERY SHEATH WITHOUT ANY INSTRUCTIONS FOR USE COMPLICATIONS. ON SIX MONTH FOLLOW UPS, THE PATIENT HAD DYSPNEA AND A 2.4MM CIRCUMFERENTIAL PERICARDIAL EFFUSION WAS SEEN IN TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A PERICARDIOCENTESIS DRAINAGE WAS PERFORMED AND MEDICATION WAS ADMINISTRATED. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Dyspnea; Pericardial Effusion

  MAUDE report 23285583 ↗
• InjuryOct 10, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  N/A

  Patient problems: Dyspnea

  MAUDE report 23265377 ↗
• DeathOct 1, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT TO TREAT A LEFT ATRIAL APPENDAGE (LAA). THE PATIENT HAD A PRE-EXISTING PERICARDIAL EFFUSION. TRANSSEPTAL ACCESS WAS INFERIOR IN THE BICAVAL, AND MID ON THE SHORT AXIS. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 317 SECONDS. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 18MMHG. FIFTEEN THOUSAND UNITS OF HEPARIN WERE ADMINISTERED. DURING THE PROCEDURE THREE ATTEMPTS WERE MADE TO DEPLOY THE OCCLUDER. IT WAS DETERMINED THAT THE OCCLUDER WAS TOO BIG IN SIZE. THE OCCLUDER WAS REMOVED AND SIZED DOWN TO A 20MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE. THE SECOND OCCLUDER WAS RE-CAPTUERED TWICE. UPON DEPLOYMENT, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION APPEARED TO BE UNCHANGED FROM BASELINE. IT WAS DISCOVERED THAT THERE WAS A SMALL PERICARDIAL EFFUSION AND A LARGER PLEURAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. IT WAS THEN NOTED THAT THE PATIENT'S LEFT LUNG COLLAPSED. A DRAIN WAS PLACED IN THE LEFT LUNG. THE PATIENT CONTINUED TO BLEED, AND A THORACOTOMY WAS PERFORMED TO CONTROL THE BLEEDING. ON (B)(6) 2025 THE PATIENT PASSED AWAY. THE CAUSE OF DEATH W

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Pleural Effusion

  MAUDE report 23192363 ↗