Amplatzer™ Amulet™ 9-ACP2-010-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 479 adverse event reports that list this exact device (DI 00811806013497), received between Jul 13, 2020 and Sep 25, 2026 — classified as 43 deaths, 388 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (111 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 479 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Patient Device Interaction Problem

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. During procedure, the patient's activated clotting time (ACT) levels were 250-274s and 14,000 units of initial Heparin dose, then additional 3000 Heparin administered after the first ACT resulted as 250. Post procedure, 45 day follow up transesophageal echocardiogram (TEE) showed a 1.5x1.0cm device related thrombus (DRT). The patient was non-compliant with taking Aspirin and Plavix, and completely did not take any of her Dual antiplatelet therapy (DAPT) medication. The patient was placed on warfarin after the DRT was found. Then, over (b)(6) the patient presented to another hospital with a stroke event. The DRT was noted to be smaller but still present at that time. The patient remains on warfarin due to the ability to monitor International Normalized Ratio (INR) levels closely for medication non-compliance. The patient was reported stable.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 50897836 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for a procedure. The patient lost pressure once device released. A pericardiocentesis was performed and drained 750cc of blood from the pericardium. After draining 750cc patient became stable and pressures normalized. Next day, the physician mentioned, the patient ended up being sent to surgery and the device was extracted and their appendage was over-sewn. The cardiothoracic (CT) surgeon mentioned to physician that there was some trauma to the distal end of the appendage, and one of the stabilizing wires perforated the appendage. The patient was in the intensive care unit (ICU) and recovering.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 50896799 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a 14F Amplatzer Amulet Delivery Sheath. During procedure, the patient's activated clotting time (ACT) levels were 258s and12000 units of Heparin was administered. The left atrial pressure at time of procedure 14mmhg. The Amulet was implanted after multiple deployments. Post procedure, a stroke was called but then neurology ruled it out. A magnetic resonance imaging (MRI) and a computed tomography angiography (CTA) of the head were clear and neurology called it an absence seizure. The patient then overnight went into cardiac tamponade and a small circumferential pericardial effusion was noted. The patient was tapped with a pericardiocentesis and recovered well. The patient has a history of alpha 1 antitrypsin disease which implanter is speculating lead to the pericardial effusion. The patient required 3 additional days of hospitalization. The patient was reported stable and home.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50817413 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. On an Unknown date, a pericardial Effusion was noted in the patient.

  Patient problems: Pericardial Effusion

  MAUDE report 50775143 ↗
• InjurySep 11, 2026Patient Device Interaction Problem

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using an Unknown Delivery System. During procedure, just before unscrew the delivery cable from the LAA Amulet Occluder, there was seen a small thread-like thrombus on the delivery cable.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50733616 ↗
• InjurySep 11, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. A routine follow-up examination was conducted on (b)(6) 2026, revealed that the occluder had embolized and was stably located in the left atrium. The occluder was subsequently successfully retrieved using a snare catheter, without causing any harm to the patient. The physicians suspect that the contractile left atrial appendage (LAA) may have displaced the occluder from its original position. The patient was in sinus rhythm. The patient was reported stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733181 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on 15 July 2026 a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using a 14F Amplatzer Amulet Delivery Sheath. This procedure was in concomitant with the Volt catheter. Transseptal access was inferior and mid. The landing zone was measured under the following degree views: 20mm at 0 degrees, 17mm at 45 degrees, 19mm at 90 degrees, and 19mm at 135 degrees. Transesophageal echocardiogram (TEE) was used during the procedure. During the procedure a tension test was performed and CLOSE criteria were met. The device was implanted. On an unknown date the patient presented with hypotension. Echo imaging showed no effusion and no changes to the Amulet. However, the patient continued to decline into pulseless electrical activity (PEA). Cardiopulmonary resuscitation (CPR) was initiated; however the patient passed away.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension

  MAUDE report 50620697 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a 12F Amplatzer Amulet Delivery Sheath. The base line effusion was trace. The activated clotting time (ACT) was only recorded only one time during procedure with additional heparin administer to achieve therapeutic level. A 4,000 units, 5,000 units, and 3,000 units of Heparin was administered. The left atrial pressure at time of procedure was 9mmHg. The Amulet was placed in appendage with no recaptures. A tension test was performed. Total device time was 8 minutes. A 1cm effusion was noticed at the end of the procedure. The size of effusion size was increased at the end of the procedure. A pericardiocentesis was performed with a total of 110ml of blood being removed and given back to the patient via their intravenous (IV). The patient remained stable throughout the Amulet procedure and the cardiac tap. The patient was reported discharged.

  Patient problems: Pericardial Effusion

  MAUDE report 50614470 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 25mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for a Left Atrial Appendage Occlusion (LAAO) procedure using a Amplatzer Torqvue 45x45 Delivery System. After the successful LAAO procedure it was noted that the patient was experiencing increasing chest tightness. A transesophageal echocardiogram (TTE) was performed which showed a developing pericardial effusion. It was planned that the patient would have a TAP (pericardiocentesis) later that day to alleviate symptoms. The patient was reported stable.

  Patient problems: Angina; Pericardial Effusion

  MAUDE report 50614397 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026 a 25 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. The patient was taking Plavix, Eliquis, and Aspirin prior to the procedure. Trace pericardial effusion was noted anteriorly prior to the procedure. The max landing zone was 21.8 mm. The patient was noted to have cactus-shaped morphology. During the procedure, the activating clotting time (ACT) was 268 seconds, and Heparin 6000 units was administered. The heart rhythm was normal sinus. The left atrial pressure was 21 mmHg. Transseptal puncture was made at the inferior-mid location. The wire was placed in the left upper pulmonary vein (LUPV). One partial recaptured was performed. The device was implanted. The patient was observed overnight and discharged the following morning following a normal transthoracic echocardiogram (TEE). On an unknown date, the patient presented to the hospital with circumferential, moderate to large, pericardial effusion. The patient had atrial fibrillation with rapid ventricular rate (RVR) related to the pericardial effusion. A pericardiocentesis was performed

  Patient problems: Arrhythmia; Pericardial Effusion

  MAUDE report 50039224 ↗
• DeathJul 27, 2026Migration or Expulsion of Device

  It was reported on (b)(6) 2026 a 25 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. The imaging modalities used during the procedure were echocardiography and angiography. The landing zone measurements were 19 mm at 0 degrees, 19 mm at 45 degrees, 20 mm at 90 degrees, and 20 mm at 135 degrees. During the procedure, fluid was given and the left atrial pressure was above 12 mmHg. Two partial recaptures were performed for repositioning. No leak was detected around the lobe, CLOSE criteria were met, and a tension test was performed. The device shape was Roman Helmet. The device was implanted. After the procedure, on the same day, echo imaging demonstrated the device embolized to the mitral valve. Cardiac surgery was performed to address the embolization. The device was removed from the body. However, during the cardiac surgery the patient went into shock and passed away.

  Patient problems: Shock

  MAUDE report 50038911 ↗
• MalfunctionJul 27, 2026Material Protrusion/Extrusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019571 ↗
• InjuryJun 30, 2026Patient-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2026 A 25 MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING AN UNKNOWN DELIVERY SHEATH FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE. THE DEVICE WAS IMPLANTED. TWO DAYS AFTER THE PROCEDURE, THE PATIENT NEEDED A PERICARDIAL SYNTHESIS. THE PATIENT STATUS WAS STABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 25673069 ↗
• InjuryApr 17, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, 25MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANTED USING AN 14F AMPLATZER TORQVUE DELIVERY SYSTEM. NO PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE, AND THE TRANSSEPTAL PUNCTURE WAS PERFORMED IN A POSTERIOR AND INFERIOR LOCATION. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE, WITH THE ACTIVATED CLOTTING TIME REPORTED TO BE GREATER THAN 300 SECONDS. APPROXIMATELY TWO MONTHS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. FURTHER EVALUATION IDENTIFIED A PERICARDIAL EFFUSION LOCALIZED TO THE LEFT ATRIAL APPENDAGE, WITH ASSOCIATED CARDIAC TAMPONADE, WHICH WAS SUBSEQUENTLY MANAGED WITH PERCUTANEOUS DRAINAGE. THE USER INDICATED A BELIEF THAT THE PERICARDIAL EFFUSION WAS CAUSED BY THE ANCHORS OF THE AMULET DEVICE. FOLLOWING THIS INTERVENTION, THE PATIENT RECOVERED AND WAS REPORTED TO HAVE NO ONGOING CONSEQUENCES.

  Patient problems: Cardiac Tamponade; Heart Failure/Congestive Heart Failure; Pericardial Effusion

  MAUDE report 24913156 ↗
• DeathApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25 MM AMPLATZER AMULET WAS IMPLANTED USING AN 14F AMULET DELIVERY SYSTEM. THE IMPLANTATION WAS REPORTED AS SUCCESSFUL. THE PROCEDURE WAS REPORTED TO HAVE BEEN PERFORMED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), AND ALL REQUIRED CRITERIA WERE FULFILLED. APPROXIMATELY 10 MINUTES AFTER COMPLETION OF THE DEVICE IMPLANTATION, THE PATIENT EXPERIENCED CLINICAL DETERIORATION AND REQUIRED RESUSCITATION. RESUSCITATIVE EFFORTS WERE CONTINUED FOR APPROXIMATELY 25 MINUTES; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL, AND THE PATIENT WAS PRONOUNCED DECEASED. THE REPORTED CAUSE OF DEATH WAS RIGHT HEART FAILURE. THE CAUSE OF DEATH WAS IDENTIFIED AS COMPLETE RIGHT VENTRICULAR FAILURE PRESENTING AS RIGHT HEART FAILURE, WITH A SUSPECTED RIGHT VENTRICULAR INFARCTION. THERE WERE REPORTED TO BE NO COMPLICATIONS RELATED TO THE OCCLUDER DEVICE. ADDITIONALLY, THE IMPLANTER CLASSIFIED THE DEATH AS LIKELY RELATED TO THE PROCEDURE AND THE PATIENT'S COMORBIDITIES RATHER THAN TO THE PERFORMANCE OF THE IMPLANTED DEVICE.

  Patient problems: Cardiac Arrest

  MAUDE report 24780445 ↗
• MalfunctionApr 3, 2026Fracture; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED ON (B)(6) 2026 A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE THE USER JOINED THE ADAPTOR ATTACHED TO THE DELIVERY SHEATH AFTER EXTRACTING THE DILATOR. WHEN ATTEMPTING TO CONNECT THE TIP OF THE AMULET'S LOADER TO THE DELIVERY SHEATH, STRONG FORCE WAS USED THAT BROKE THE BLUE LUER LOCK. THE DEVICE WAS REPLACED WITH A NEW 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. 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 24774885 ↗
• InjuryMar 31, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMULET TORQVUE DELIVERY SHEATH. AFTER THE PROCEDURE, PATIENT BECAME UNSTABLE IN RECOVERY REQUIRING SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information; Perforation

  MAUDE report 24749807 ↗
• InjuryMar 31, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (b)(6) 2026, A 25MM AMPLATZER AMULET WAS IMPLANTED USING AN 12F DELIVERY SYSTEM. PRIOR TO THE AMULET IMPLANT, A TRIVIAL PERICARDIAL EFFUSION WAS NOTED. A TRANSSEPTAL PUNCTURE WAS PERFORMED IN AN INFERIOR/MID LOCATION, WITH A REPORTED LEFT ATRIAL PRESSURE OF 11MMHG AT THE TIME OF THE PROCEDURE. DURING THE PROCEDURE, HEPARIN WAS ADMINISTERED AT A DOSE OF 15,000 UNITS, ACHIEVING AN ACTIVATED CLOTTING TIME (ACT) OF 310 SECONDS. THE DEVICE REQUIRED ONE REPOSITIONING DURING IMPLANTATION, WITH NO MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES REPORTED AND WIRE POSITION NOT CHANGING BETWEEN PULMONARY VEINS. PROTAMINE WAS ADMINISTERED DIRECTLY AFTER SHEATH REMOVAL. ON (b)(6) 2026, IT WAS DISCOVERED THAT THE PATIENT EXPERIENCED PERICARDIAL EFFUSION. THE USER REPORTED THE BELIEF THAT THE PERICARDIAL EFFUSION WAS CAUSED BY THE AMULET DEVICE.

  Patient problems: Pericardial Effusion

  MAUDE report 24749772 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT (B)(6) 2026, A 25MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 12F AMULET DELIVERY SYSTEM. AT BASELINE, NO PERICARDIAL EFFUSION WAS PRESENT PRIOR TO THE START OF THE PROCEDURE. THE PATIENT WAS IN SINUS RHYTHM, AND HEPARIN WAS ADMINISTERED DURING THE PROCEDURE AT A TOTAL DOSE OF 15,000IU, ACHIEVING AN ACTIVATED CLOTTING TIME (ACT) GREATER THAN 300 SECONDS, WITH NO PROTAMINE OR REVERSAL AGENT ADMINISTERED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED VIA AN INFERIOR POSTERIOR APPROACH, AND THE GUIDEWIRE WAS POSITIONED IN THE UPPER PULMONARY VEIN WITHOUT MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES. DURING ADVANCEMENT OF THE DELIVERY SYSTEM, DIFFICULTY WAS ENCOUNTERED IN BRINGING THE DELIVERY SHEATH INTO THE LEFT ATRIAL APPENDAGE, REQUIRING MANIPULATION. DURING THE LEFT ATRIAL APPENDAGE IMPLANTATION ATTEMPT, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THE EFFUSION WAS CIRCUMFERENTIAL, LOCALIZED PREDOMINANTLY AROUND THE RIGHT VENTRICLE, WITH A MAXIMUM MEASURED DIMENSION OF 0.4MM. THERE WAS NO EVIDENCE OF CARDIAC TAMPONADE, AND THE EFFUSION WAS NOT BELIEVED TO BE CAUSED BY THE ABBOTT DEVICE. AS A RESULT OF THE EFFUSION, THE PROCEDURE WAS STOPPED. THE PERICARDIAL EFFU

  Patient problems: Pericardial Effusion

  MAUDE report 24737451 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING AN 14F AMULET DELIVERY SYSTEM. PRIOR TO THE PROCEDURE, IMAGING SHOWED A LARGE, CIRCUMFERENTIAL PERICARDIAL EFFUSION, WHICH WAS KNOWN TO THE IMPLANTING AND IMAGING PHYSICIANS. THE TRANSSEPTAL PUNCTURE WAS REPORTED TO BE DIFFICULT; THE TRANSSEPTAL SHEATH AND DILATOR WERE REMOVED AND REPOSITIONED BEFORE A SUCCESSFUL INFERIOR/MID TRANSSEPTAL PUNCTURE WAS MADE, AFTER WHICH THE TRANSSEPTAL SHEATH WAS EXCHANGED FOR AN14 F AMULET DELIVERY SHEATH. ANTICOAGULATION WAS ADMINISTERED WITH ACT MAINTAINED AT =250 SECONDS, LEFT ATRIAL PRESSURE WAS 12 MMHG, AND THE LAA WAS ACCESSED USING A PIGTAIL CATHETER WITHIN THE AMULET DELIVERY SHEATH, WITHOUT PLACING A WIRE DIRECTLY INTO THE APPENDAGE. DURING DEVICE DEPLOYMENT, THERE WAS DIFFICULTY WITH POSITIONING, REQUIRING TWO PARTIAL RECAPTURES, AND WHILE THE DEVICE WAS IN THE BALL POSITION AND BEING EVALUATED PRIOR TO RELEASE, THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE, AND IMAGING SHOWED A WORSENING OF THE EXISTING CIRCUMFERENTIAL PERICARDIAL EFFUSION. IMAGING LATER SUGGESTED THAT THE DISTAL END SCREW OF THE AMULET DEVICE WAS CONTACTING THE WALL OF THE LEFT A

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24652680 ↗
• InjuryMar 20, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMULET DELIVERY SYSTEM. NO PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. TRANSSEPTAL ACCESS WAS OBTAINED VIA AN INFERIOR ANTERIOR TRANSSEPTAL PUNCTURE, AND HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. THE LEFT ATRIAL PRESSURE AT THE TIME OF THE PROCEDURE WAS REPORTED TO BE 10 MMHG. THERE WAS NO REPORTED DIFFICULTY WITH DEVICE IMPLANTATION, AND NO MULTIPLE DEVICE MANIPULATIONS WERE DOCUMENTED. DURING THE PROCEDURE, A SHEATH EXCHANGE WAS PERFORMED IN THE LEFT ATRIUM, AND A WIRE MAY HAVE BEEN PLACED IN THE LEFT ATRIAL APPENDAGE, POSSIBLY A VERSACROSS WIRE. ON (B)(6) 2026, THE PATIENT PRESENTED WITH A DELAYED PERICARDIAL EFFUSION, WHICH WAS DESCRIBED AS CIRCUMFERENTIAL IN NATURE. THE EFFUSION WAS NOT LOCALIZED TO A SPECIFIC CARDIAC STRUCTURE AND WAS NOTED TO BE CIRCUMFERENTIAL AROUND THE HEART. A TOTAL OF 900 CC OF FLUID WAS DRAINED VIA PERICARDIOCENTESIS, AFTER WHICH THE PATIENT WAS REPORTED TO BE STABLE. THE REPORTER INDICATED A BELIEF THAT THE PERICARDIAL EFFUSION WAS CAUSED BY THE ABBOTT AMPLATZER AMULET DEVICE.

  Patient problems: Pericardial Effusion

  MAUDE report 24651886 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 12F AMULET DELIVERY SHEATH. DURING THE PROCEDURE, WHILE DEPLOYMENT, THE TEAM OBSERVED A SMALL THROMBUS FORMATION AT THE DELIVERY CABLE. THE PHYSICIAN DID NOT INDICATE ANY RELATIONSHIP BETWEEN THE THROMBUS AND THE AMULET DEVICE. THE THROMBUS WAS DESCRIBED AS SMALL THREADS IN APPEARANCE. THE SHEATH HAD NOT BEEN IN THE PATIENT FOR A SIGNIFICANT PERIOD OF TIME. DURING THE PROCEDURE, THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE 361 AND 401, AND HEPARIN WAS ADMINISTERED. THE THROMBUS WAS DETECTED USING TEE IMAGING. THE DELIVERY SHEATH WAS NOT REUSED WITH MULTIPLE AMULET OCCLUDERS, AND THE AMULET OCCLUDER WAS NEVER FULLY RESHEATHED AND CONTINUED FOR USE DURING THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24621581 ↗
• DeathMar 9, 2026Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER AMULET DELIVERY SYSTEM. THE PATIENT¿S CONDITION PRIOR TO THE PROCEDURE WAS REPORTED AS NORMAL WITH NO ABNORMALITIES, AND NO PERICARDIAL EFFUSION WAS NOTED PRIOR TO THE PROCEDURE. THE PATIENT WAS IN ATRIAL FIBRILLATION, WAS TAKING ORAL ANTICOAGULATION, AND RECEIVED HEPARIN (10,000 IE) DURING THE PROCEDURE, WITH AN ACTIVATED CLOTTING TIME OF GREATER THAN 250 MS. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AT THE INFERIOR/POSTERIOR LOCATION. DURING THE PROCEDURE, A WIRE WAS PLACED IN THE LEFT ATRIAL APPENDAGE, AND THE DEVICE WAS PARTIALLY RECAPTURED ONCE; HOWEVER, NO DIFFICULTIES OR MULTIPLE MANIPULATIONS, AND NO MULTIPLE WIRE OR SHEATH EXCHANGES, WERE REPORTED. A FEW HOURS AFTER SUCCESSFUL IMPLANTATION OF THE AMULET OCCLUDER, A CIRCUMFERENTIAL PERICARDIAL EFFUSION DEVELOPED, AND THE PHYSICIANS REPORTED THE PRESENCE OF CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED TO ADDRESS THE EFFUSION. THE IMPLANTER INDICATED THAT THE EVENT WAS LIKELY RELATED TO THE PROCEDURE, ALTHOUGH THEY BELIEVED THAT THE AMULET DEVICE CAUSED THE PERICARDIAL EFFUSION. THE PATIENT SUBSEQUENTLY WENT INTO CARD

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24550735 ↗
• InjuryMar 6, 2026Migration or Expulsion of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM. THE CASE WAS CONSIDERED CHALLENGING DUE TO A PRIOR UNSUCCESSFUL WATCHMAN IMPLANT. LANDING ZONE MEASUREMENTS USED TO DETERMINE DEVICE SIZING WERE REPORTED AS 25, 16, 16, AND 22 AT 0°, 45°, 90°, AND 135°, RESPECTIVELY, AND SIZING WAS BASED ON TEE MEASUREMENTS. TEE WAS USED AS THE IMAGING MODALITY DURING THE IMPLANT. DURING THE PROCEDURE, THREE DIFFERENT DEVICES WERE ATTEMPTED: FIRST A 28 MM DEVICE, FOLLOWED BY A 22 MM DEVICE, AND FINALLY A 25 MM AMULET, WHICH WAS IMPLANTED. IT WAS CONFIRMED THAT NO OTHER PRODUCT ISSUES OR MALFUNCTIONS WERE INVOLVED WITH THE 28MM AMPLATZER AMULET AND 22MM AMPLATZER AMULET OTHER THAN MIS-SIZING. THE LEFT ATRIAL PRESSURE AT THE TIME OF THE PROCEDURE WAS REPORTED TO BE BELOW 12, AND FLUIDS WERE ADMINISTERED DURING THE PROCEDURE. BECAUSE OF THE DIFFICULTY OF THE CASE, THE TEAM IMPLEMENTED A FIVE-MINUTE OBSERVATION PERIOD TO ASSESS DEVICE STABILITY. AT THE END OF THIS PERIOD, THE DEVICE APPEARANCE REMAINED UNCHANGED, AND THE CASE WAS CONCLUDED. THE DEVICE SHAPE AT THE TIME OF IMPLANT WAS BELIEVED TO BE CONSISTENT WITH A TIRE CONFIGURATION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24536705 ↗
• DeathMar 6, 2026Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMULET DELIVERY SYSTEM.THE PATIENT WAS REPORTED TO BE STABLE PRIOR TO THE PROCEDURE AND IN NORMAL SINUS RHYTHM. TRANSSEPTAL PUNCTURE WAS PERFORMED AT AN INFERIOR/MID-ANTERIOR LOCATION, AFTER WHICH A TRIVIAL BASELINE PERICARDIAL EFFUSION WAS NOTED. THE INITIAL PLAN WAS TO IMPLANT A 22 MM AMPLATZER AMULET; HOWEVER, AFTER TWO RECAPTURES THE DEVICE DEMONSTRATED INADEQUATE STABILITY AND COMPRESSION, PROMPTING AN UPSIZE TO A 25 MM DEVICE. ANTICOAGULATION DURING THE CASE INCLUDED HEPARIN (ACT 250¿350 SECONDS), AND PROTAMINE WAS ADMINISTERED. A SINGLE EXCHANGE TO A TORQVUE 14F DELIVERY SYSTEM WAS PERFORMED OVER A VERSACROSS WIRE THAT HAD ENGAGED THE LAA, WITH THE SHEATH ADVANCED TO THE MID LEFT ATRIUM AND THE LAA ENGAGED USING A PIGTAIL CATHETER. THE 25 MM AMULET WAS POSITIONED SUCCESSFULLY AFTER ONE ADDITIONAL (PARTIAL) RECAPTURE DUE TO A MITRAL SHOULDER; THERE WAS ONE PARTIAL RECAPTURE WITH THE 25 MM DEVICE, ONE COMPLETE RECAPTURE INTO THE DELIVERY SYSTEM, AND THE DEVICE WAS EXCHANGED WHILE THE SHEATH WAS REUSED AFTER A CONSIDERABLE BACKBLEED. BECAUSE TEE IMAGING WAS CHALLENGING, ANGIOGRAPHY W

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

  MAUDE report 24535930 ↗