Amplatzer™ Amulet™ 9-ACP2-010-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 284 adverse event reports that list this exact device (DI 00811806013503), received between Aug 26, 2021 and Sep 25, 2026 — classified as 33 deaths, 218 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (89 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 284 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Difficult to Fold, Unfold or Collapse

  It was reported that on (b)(6) 2026, a 28mmAmplatzer Amulet Left Atrial Appendage Occluder was chosen for implant using a 14F Amplatzer delivery sheath. During the procedure, while deployment the physician noted that the device was not taking desired shape, so they have to retrieve the device back. The deformed device was never released from the delivery cable while inside the patient. There was no angulation or kink noted in the delivery system. There was no interaction with cardiac structures during deployment. The procedure was aborted. The patient remained hemodynamically stable throughout the procedure. There was no clinically significant delay in procedure and no adverse patient effects reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903118 ↗
• DeathSep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 28mm Amplatzer Amulet was chosen for implant. It was then reported on an unknown date that the patient passed away. Cause of death was not reported. No autopsy was performed.

  Patient problems: Insufficient Information

  MAUDE report 50875147 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 28mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. On (b)(6) 2026, the patient was readmitted with large pericardial effusion and required a pericardial window.

  Patient problems: Pericardial Effusion

  MAUDE report 50718164 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026 a 28mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using a 14F Amplatzer Amulet Delivery Sheath. Transseptal puncture was inferior and mid. The patient's activated clotting time (ACT) level was 250 seconds. The left atrial pressure was 11mmHg. Heparin was administered. The device was implanted. Protamine was administered. On (b)(6) 2026 the patient was found unresponsive and was transported to the emergency room of a different hospital. The patient had a low systolic blood pressure in the 60's at the nursing facility but was in the 100's upon admission. The patient was unable to speak and was confused, indicative of a stroke. A chest x-ray demonstrated cardiomegaly and a Watchman that was also implanted the day prior. Computed tomography angiography revealed a high-density pericardial effusion with cardiac tamponade. A pericardiocentesis was planned; however during preparation, the patient went extremely bradycardic and within a minute or so passed away. The cause of death was cardiac arrest.

  Patient problems: Bradycardia; Cardiac Arrest; Cardiac Tamponade; Cognitive Changes; Movement Disorder; Pericardial Effusion; Stroke/CVA; Syncope/Fainting

  MAUDE report 50615786 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a 28mm Amplatzer Amulet Left Atrial Appendage Occluder was implanted in the patient. The patient got neurological noticeable the night after the Amulet implantation and they transported him to another hospital. A stroke was suspected.

  Patient problems: Stroke/CVA

  MAUDE report 50382751 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on 15 December 2022, a 28 mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using an unknown delivery sheath for a left atrial appendage (LAA) closure. On (b)(6) 2026, the patient presented to (b)(6) Hospital with complaints of dizziness, weakness, and reported fall. The patient was transferred to (b)(6) Hospital on the same day and was found to have had a right Middle Cerebral Artery (MCA) stroke. The patient was discharged from the hospital to a skilled nursing facility on (b)(6) 2026.

  Patient problems: Fatigue; Movement Disorder; Stroke/CVA

  MAUDE report 50197689 ↗
• InjuryAug 7, 2026Migration or Expulsion of Device

  It was reported on (b)(6) 2026 a 28 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. Transesophageal echocardiogram (TEE), X-ray, and 2-D TEE were used during the procedure and to determine the device size. The landing zone measurements were 21 mm at 0 degrees, 19 mm at 45 degrees, 22 mm at 90 degrees, and 25 mm at 135 degrees. During the procedure fluid was given. Two partial recaptures were performed to achieve greater depth. No leak was detected, CLOSE criteria were met, and a tension test was performed. The device was implanted. Two hours after the procedure while in recovery, transthoracic echocardiogram (TTE) confirmed the device embolized to the mitral valve apparatus. The device was snared using a MitralClip guide and removed from the body. The lateral leaflets of the mitral valve sustained damage from the retrieval process. Mitral regurgitation and mild atrial septal defect were observed but resolved over time. The patient status was stable and discharged to home. The physician suspects the embolization may be related to the change in heart rhythm from atrial

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Unspecified Tissue Injury

  MAUDE report 50178175 ↗
• InjuryAug 5, 2026Migration or Expulsion of Device

  It was reported on (b)(6) 2026 a 28 mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using an unknown delivery sheath for a left atrial appendage (LAA) closure. The imaging modalities used during the procedure were transesophageal echocardiogram (TEE) and angiography. Device sizing was determined using TEE. The landing zone measurement was 24 X 17 mm. Fluid was given during the procedure. A 2 mm leak around the lobe was observed during the procedure. CLOSE criteria were met and a tension test was performed. The device was implanted. The device was tire shaped. A few hours after the procedure, transthoracic echocardiogram (TTE) confirmed the device had embolized to the mitral valve and a partial obstruction of blood flow was observed and the patient had a drop in blood pressure. The device was removed from the body via snare.

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 50144252 ↗
• InjuryJul 29, 2026Migration or Expulsion of Device

  It was reported on 07 July 2026 a 28 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. Transesophageal echocardiogram (TEE) and angiography imaging modalities were used to determine device sizing and were used during the procedure. The landing zone measurements were 17 mm at 45 degrees, 21 mm at 130 degrees, and 21.5 mm in angiography. The left atrial pressure was above 12 mmHg, 500 ml fluid was given, and the repeat left atrial pressure was above 15 mmHg. No leak was detected. CLOSE criteria were satisfied and a tension test was performed. The device was implanted. The device was strawberry shaped. Shortly after release, TEE confirmed that the device embolized to the left atrium. The device was snared and removed from the patient. The procedure was completed with a Non-Abbott device. After the Non-Abbott device was implanted, a pericardial effusion was noted. A pericardiocentesis was performed. The patient status was stable. The physician suspected the cause of the embolization to be related to device oversizing and insufficient anchoring.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pericardial Effusion

  MAUDE report 50070920 ↗
• InjuryJul 27, 2026Patient Device Interaction Problem

  It was reported on (b)(6) 2025 a 28 mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using a 14F Amplatzer delivery sheath for a left atrial appendage (LAA) closure. Prior to the procedure, the patient was taking Apirin and Plavix. The activating clotting time (ACT) was 258 seconds. Heparin 12,000 units was administered. The device was implanted. On (b)(6) 2026, transesophageal echocardiogram (TEE) confirmed a laminar/triangle shaped thrombus on the disc at the 6 month follow up post implant. The patient was started on Xarelto to manage the thrombus. The patient status was stable.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50039228 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2026 A 25 MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER AMULET DELIVERY SHEATH FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE. PRIOR TO THE PROCEDURE, A SMALL EFFUSION AND FLUID WAS NOTED IN THE TRANSVERSE SINUS. DURING THE PROCEDURE, THE PATIENT ANATOMY WAS NOTED TO BE DIFFICULT. HEPARIN WAS ADMINISTERED. THE WIRE WAS PLACED IN THE LAA. THE DEVICE WAS REPOSITIONED ONCE THEN DEPLOYED. THE DEVICE WAS THEN FULLY RECAPTURED AND REMOVED FROM THE BODY DUE TO NEEDING A LARGER SIZE. A NEW 28 MM AMPLATZER AMULET WAS SELECTED USING THE SAME DELIVERY SHEATH. THE DEVICE WAS REPOSITIONED ONCE. THE DEVICE WAS IMPLANTED. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH CHEST PAIN. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED PERICARDIAL FLUID. A PERICARDIOCENTESIS WAS ATTEMPTED BUT WAS UNABLE TO REMOVE FLUID. THE PATIENT WAS KEPT OVERNIGHT IN THE HOSPITAL FOR OBSERVATION THEN DISCHARGED HOME IN STABLE CONDITION.

  Patient problems: Angina; Pericardial Effusion

  MAUDE report 25638594 ↗
• DeathMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 20 APRIL 2026 A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER AMULET DELIVERY SHEATH. THE DEVICE WAS IMPLANTED. TWO DAYS POST-PROCEDURE, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR A SYSTOLIC EMBOLISM AND KIDNEY INFARCTION. THE PATIENT WAS SEPTIC AND WENT INTO CARDIAC ARREST, ULTIMATELY PASSING AWAY ON (B)(6) 2026. THE DEVICE APPEARED IN STABLE POSITIONING. THE USER SUSPECTED THE PATIENT HAD UNDERLYING CARDIOGENIC SHOCK THAT WAS UNIDENTIFIED, BUT THIS WAS NOT CONFIRMED. THE OFFICIAL CAUSE OF DEATH WAS SEPSIS.

  Patient problems: Cardiac Arrest; Embolism/Embolus; Renal Failure; Sepsis

  MAUDE report 25260083 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 28MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMULET DELIVERY SHEATH. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AT AN INFERIOR/POSTERIOR LOCATION, AND THE PATIENT WAS IN SINUS RHYTHM AT THE TIME OF THE PROCEDURE. THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) WAS 270 SECONDS, NO PROTAMINE OR REVERSAL AGENTS WERE ADMINISTERED, AND THE LEFT ATRIAL PRESSURE WAS 12 MMHG. THE SHEATH WAS NOT IN THE PATIENT LONGER THAN USUAL. DURING ADVANCEMENT OF THE SYSTEM, THE TEAM EXPERIENCED DIFFICULTY AS THEY COULD NOT REACH THE LEFT ATRIAL APPENDAGE (LAA) EASILY. A WIRE WAS POSITIONED IN THE UPPER PULMONARY VEIN, AND AT ONE POINT A WIRE WAS ALSO PLACED IN THE LEFT ATRIAL APPENDAGE. THERE WAS ONE EXCHANGE OF THE DELIVERY SHEATH. THE AMULET DEVICE UNDERWENT TWO PARTIAL RECAPTURES, AND DURING RECAPTURE, THE DEVICE WAS RETRACTED INTO THE BALL CONFIGURATION. AFTER THESE RECAPTURE ATTEMPTS, A STRUCTURE WAS OBSERVED NEAR THE DEVICE ON TEE IMAGING. THE STRUCTURE WAS DESCRIBED AS A NARROW ELONGATED STRUCTURE, AND THE TEAM REPORTED THAT IT LOOKED LIKE A LITTLE THROMBUS, THOUGH IT WAS NOT CONFIRMED TO BE ONE. THEY STATED THAT THEY DID NOT KNOW IF IT WAS A THROMBUS,

  Patient problems: Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 24589377 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24537182 ↗
• InjuryMar 6, 2026Patient-Device Incompatibility

  N/A.

  Patient problems: Pericardial Effusion

  MAUDE report 24536413 ↗
• InjuryFeb 27, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE. THE SHAPE OF THE APPENDAGE WAS BROCCOLI-SHAPED. THE LANDING ZONE MEASUREMENTS WERE 18.4¿27.7 MM. ON 135° TEE, A SMALL DISTAL PECTINATE MUSCLE WAS DEVELOPED, AND THE MORPHOLOGY WAS RELATIVELY SHALLOW. INTRAOPERATIVELY, THE LEFT ATRIAL PRESSURE WAS 12 MMHG. PLACEMENT OF A 35-MM WATCHMAN DEVICE WAS ATTEMPTED; HOWEVER, THE DEVICE WAS NOT STABLE ON THE TUG TEST AFTER DEPLOYMENT AND MIGRATED INTO THE LEFT ATRIAL APPENDAGE, RESULTING IN AN UNSTABLE POSITION. THE DEVICE WAS THEREFORE CHANGED TO AN AMULET DEVICE. AFTER DISC DEPLOYMENT, THE CLOSE SIGN WAS CHECKED, AND IMAGES WERE CONFIRMED WITH COLOR DOPPLER IMAGING, A TENSION TEST, AND CONTRAST ANGIOGRAPHY. THE AMULET POSITION BECAME STABLE ON THE SECOND DEPLOYMENT. THE DEVICE COMPRESSION WAS IN A TIRE SHAPE. THERE WAS NO SIGNIFICANT PERI-DEVICE LEAK WAS OBSERVED, AND THE DISTANCE BETWEEN THE PULMONARY ARTERY AND THE LEFT ATRIAL APPENDAGE WAS CONSIDERED ACCEPTABLE AT =3 MM. THERE WAS NO PERICARDIAL EFFUSION OR OTHER SIGNS OF COMPLICATIONS WERE OBSERVED UNTIL THE PATIENT LEF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470502 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 26MM AMPLATZER AMULET WAS IMPLANTED USING AN UNKNOWN DELIVERY SYSTEM. THERE WERE NO RECAPTURES DURING THE PROCEDURE. THE PATIENT WAS NOTED TO BE IN BIGEMINY AT THE TIME OF IMPLANTATION. ON THE SAME DAY, A CARDIAC TAMPONADE WITH ASSOCIATED PERICARDIAL EFFUSION OCCURRED. THE EFFUSION WAS DRAINED, AND THE PATIENT REMAINED OVERNIGHT FOR OBSERVATION WITHOUT THE NEED FOR PRESSOR SUPPORT. ON (B)(6) 2026, A PERICARDIAL EFFUSION WAS REPORTED AGAIN. THE PHYSICIAN INDICATED THAT THE TRANSSEPTAL PUNCTURE (TSP) WAS THE LIKELY CAUSE OF THE EFFUSION, NOTING THAT THE PATIENT HAD A SMALL LEFT ATRIUM. THE PATIENT IS REPORTED TO BE AT HOME AND STABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 24422866 ↗
• InjuryFeb 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, AN UNKNOWN AMPLATZER WAS IMPLANTED USING AN UNKNOWN DELIVERY SYSTEM. ON (B)(6) 2026, A DOCTOR REPORTED THE PRESENCE OF DEVICE-RELATED THROMBUS (DRT) IN A PATIENT WITH AN AMULET DEVICE, IDENTIFIED DURING A RECENT TOE FOLLOW-UP EXAMINATION. THE TOE REPORTEDLY SHOWED SIGNIFICANT SPONTANEOUS ¿SMOKE¿. THE PATIENT WAS NOTED TO BE ON THE THROMBIN INHIBITOR DABIGATRAN. THE INITIAL INDICATION FOR LEFT ATRIAL APPENDAGE CLOSURE WAS HEMATURIA. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24405581 ↗
• InjuryFeb 20, 2026Patient Device Interaction Problem

  CLINICAL INFORMATION: (B)(4) - ADVANCE LAA, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING AN AMULET¿ STEERABLE DELIVERY SHEATH. THE LEFT ATRIAL APPENDAGE (LAA) DEPTH WAS 20MM. THE LAA MEASURING FOR AMULET DEVICE SIZING WAS DONE BY 2D TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS 13MMHG AND THE SHAPE OF THE APPENDAGE WAS CHICKEN WING. THE ATRIAL RHYTHM RECORDED AT START OF PROCEDURE WAS ATRIAL FIBRILLATION. THE ACTIVATED CLOTTING LEVELS WERE 324S AND HEPARIN WAS GIVEN. THE AMULET WAS SUCCESSFULLY IMPLANTED. ON 45 DAY TEE NOTED TO HAVE A THROMBUS ON THE SURFACE OF THE DEVICE. THE THROMBUS WAS 1CM IN SIZE THE PATIENT HAD NO SYMPTOMS. THE PATIENT ADMITTED TAKING CLOPIDOGREL INCONSISTENTLY DUE TO BLEEDING ISSUES. THEY DECIDED TO DISCONTINUE CLOPIDOGREL AND INITIATED DIRECT ORAL ANTICOAGULANT (DOAC/NOAC) AND ASPIRIN. ON (B)(6) 2025, A REPEAT TEE WAS CONDUCTED AND NO THROMBUS WAS NOTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24401070 ↗
• InjuryFeb 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 CHOSEN FOR IMPLANT USING AN 14F AMULET DELIVERY SYSTEM. THE PATIENT WAS PRESCRIBED ELIQUIS, HAD A REPORTED INR OF 1.3 ON THE DAY OF THE PROCEDURE. FOLLOWING VENOUS ACCESS AND IMAGING SETUP, TEE IMAGING WAS USED TO GUIDE THE CASE. HEPARIN WAS ADMINISTERED INTRA-PROCEDURALLY, WITH A TOTAL OF 15,000 UNITS GIVEN, AND THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) WAS 333. DURING THE PROCEDURE, WHEN THE PHYSICIAN UNSHEATHED THE DEVICE TO THE BALL POSITION, A SMALL CLOT WAS OBSERVED ON THE BALL-SHAPED PORTION OF THE AMULET DEVICE. THE CLOT WAS DESCRIBED AS VERY SMALL, APPEARING BRIGHT ON THE TEE IMAGING SCREEN, AND LOCATED AT THE TIP OF THE BALL NEAR THE DISTAL END SCREW. DUE TO THE PRESENCE OF THIS THROMBUS, THE PHYSICIAN WAS ADVISED NOT TO PROCEED WITH DEPLOYMENT AND WAS INSTRUCTED TO CAREFULLY RECAPTURE THE DEVICE. CONSIDERING THE OBSERVED THROMBUS AND THE PATIENT¿S COMPLEX ANATOMY THE PHYSICIAN WAS ADVISED NOT TO PROCEED WITH THE DEPLOYMENT STEPS DUE TO THE PRESENCE OF THE CLOT AND WAS INSTRUCTED TO CAREFULLY RECAPTURE THE DEVICE. THE PROCEDURE WAS SUBSEQUENTLY ABORTED BASED ON THESE FINDINGS AND THE PATIENT¿S COMPLEX ANAT

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24335035 ↗
• InjuryJan 23, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER TORQVUE DELIVERY SHEATH. INITIALLY A 25MM AMPLATZER AMULET DEVICE WAS ATTEMPTED INITIALLY BUT IT DID NOT PASS THE TENSION TEST AND THEREFORE IT WAS REMOVED AND A 28MM AMPLATZER AMULET WAS IMPLANTED AND NOTED THAT IT MET THE CLOSE CRITERIA. IT WAS ALSO NOTED THAT THIS WAS IMPLANTED DURING A CONCOMITANT PROCEDURE AND IT WAS REPORTED THAT THIS WAS A CHALLENGING CASE DURE TO HEAVY PECTINATE ANATOMY AND PRE-PROCEDURE WAS ATTEMPTED INITIALLY. LANDING ZONE MEASUREMENTS USED FOR SIZING WERE OBTAINED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND INCLUDED THE FOLLOWING: AT 0°¿OSTIUM 30MM, LANDING ZONE 21MM, DEPTH 28MM; AT 45°¿OSTIUM 29MM, LANDING ZONE 19MM, DEPTH 27MM; AT 90°¿OSTIUM 30MM, LANDING ZONE 21MM, DEPTH 26MM; AT 135°¿OSTIUM 30MM, LANDING ZONE 23MM (DEPTH NOT AVAILABLE). DEVICE SIZING WAS DETERMINED USING THESE TEE MEASUREMENTS, AND THE 25¿MM DEVICE WAS INITIALLY SELECTED BASED ON THESE VALUES; HOWEVER, THE 25MM DEVICE POPPED OUT DURING THE TUG TEST, PROMPTING SELECTION OF THE 28MM DEVICE. TEE AND FLUOROSCOPY WERE USED DURING THE PROCEDURE. THE DEVICE SHAPE AT IMPLANT WAS DESCRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24169067 ↗
• MalfunctionJan 20, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28 AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING AN ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE OCCLUDER WAS NOT CONFORMING TO ITS DESIRED SHAPE. THE PROCEDURE WAS ABORTED. THE DEFORMED DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE. THERE WAS NO INTERACTION WITH THE CARDIAC STRUCTURES DURING DEPLOYMENT, AND NO ANGULATION/KINK WERE NOTICED IN THE DELIVERY SYSTEM. THE 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 24122415 ↗
• InjuryJan 14, 2026Migration or Expulsion of Device

  IT WAS REPOPRTED THAT ON (B)(6) 2025, A 28MM AMPLATZER AMULET WAS CHOSEN FOR IMPLANT USING A 14F AMULET DELIVERY SHEATH. PRE-IMPLANT LANDING ZONE MEASUREMENTS WERE 20/21 MM AT 45° AND 22/23 MM AT 130°, AND DEVICE SIZING WAS DETERMINED WITH A SIZING CARD. TRANSESOPHAGEAL ULTRASOUND WAS USED AS THE IMAGING MODALITY DURING THE PROCEDURE. AFTER DEPLOYMENT, THE DEVICE EXHIBITED A BARREL SHAPE, A TENSION TEST WAS PERFORMED TWICE, THE CLOSE CRITERIA WERE SATISFIED, THERE WAS NO RHYTHM CHANGE, NO LEAK WAS DETECTED AROUND THE LOBE, NO FLUID WAS ADMINISTERED, AND THEREFORE LEFT ATRIAL PRESSURE WAS NOT RE-MEASURED AFTER FLUIDS. SUBSEQUENTLY, IT WAS NOTED THAT THE DEVICE MIGRATED; MIGRATION WAS IDENTIFIED ON TRANSESOPHAGEAL ULTRASOUND, THE DEVICE WAS COMPLETELY DISLODGED FROM THE IMPLANT SITE, AND THE IMPLANTER DID NOT KNOW THE CAUSE OF THE EMBOLIZATION/MIGRATION. SURGICAL INTERVENTION WAS PERFORMED TO ADDRESS THE MIGRATION, AND THE PATIENT WAS TRANSFERRED TO THE SURGERY DEPARTMENT OF ANOTHER HOSPITAL. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, WITH NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24075012 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMULET DELIVERY SHEATH IN A COMPLEX LEFT ATRIAL APPENDAGE (LAA). TWO RECAPTURES WERE REQUIRED DUE TO ANATOMICAL COMPLEXITY. A SATISFACTORY IMPLANT WAS ACHIEVED, AND NO CHANGE IN EFFUSION WAS NOTED FOLLOWING DEVICE RELEASE. ON (B)(6) 2025, IT WAS FURTHER REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL WITH CHEST PAIN. DIAGNOSTIC EVALUATION REVEALED A HEMOPNEUMOTHORAX AND A SMALL PERICARDIAL EFFUSION. THE EFFUSION WAS NOT DRAINED AS INTERVENTION WAS DEEMED UNNECESSARY. THE PATIENT WAS STABILIZED AND SUBSEQUENTLY DISCHARGED. THE PHYSICIAN DID NOT ATTRIBUTE THE HEMOPNEUMOTHORAX TO THE DEVICE BUT WAS UNCERTAIN REGARDING THE EXACT CAUSE OF THE SEQUELAE.

  Patient problems: Angina; Hemothorax; Pericardial Effusion

  MAUDE report 24035584 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM AMPLATZER AMULET WAS IMPLANTED IN A SINGLE DEPLOYMENT USING A 14F AMPLATZER AMULET TORQVUE DELIVERY SHEATH. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS DIFFICULTY CROSSING THE SEPTUM WITH THE SHEATH, BUT THE DEVICE WAS DEPLOYED WITH ONLY ONE DEVICE DEPLOYMENT AND NO RECAPTURES. THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE WITHIN 250¿300, AND HEPARIN WAS ADMINISTERED. ON AN UNKNOWN DATE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE AND WAS TREATED. THE PERICARDIAL EFFUSION WAS RESOLVED BY PERICARDIOCENTESIS. AT THE TIME THE EFFUSION WAS DETECTED, THE PATIENT WAS ON DAPT (DUAL ANTIPLATELET THERAPY). WIRE EXCHANGES WERE PERFORMED WITH WIRE POSITIONED IN THE LEFT UPPER PULMONARY VEIN (LUPV). THE LEFT ATRIAL PRESSURE AT THE TIME OF THE PROCEDURE WAS 12¿MMHG. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23967794 ↗