Amplatzer™ Amulet™ 9-ACP2-007-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00811806013459), received between May 20, 2022 and Jul 30, 2026 — classified as 3 deaths, 31 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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 42 reports, in the reporter's own words as published by the FDA.

• DeathJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2026 a 16 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 patient was taking an oral anticoagulant prior to the procedure. The LAA was characterized to be small with a long distance noted from the ostium to the neck with substantial depth. The imaging modalities used were 2D (TEE) and 3D multiplanar reconstruction (MPR). The landing zone measurements were 13.2 mm at 0 degrees, 12.4 mm at 45 degrees, 12.2 mm at 90 degrees, and 11.7 mm at 135 degrees. The ostium diameter was 13.2 mm on 2D TEE. A considerable height, measured about 12.7 mm, was observed between the landing zone and the pulmonary vein (PV) ridge. During the procedure, the activating clotting time (ACT) was 170 second and and Heparin was administered. The heart rhythm was normal sinus and the left atrial pressure was 12 mmHg. Transseptal puncture was made at the inferior mid location. The wire was positioned in the left upper pulmonary vein. Deployment was performed more gradually than usual, progressing from the ball to triangle configuration given the LAA anatomy. TEE confir

  Patient problems: Cardiac Tamponade; Fatigue; Pericardial Effusion

  MAUDE report 50087331 ↗
• InjuryJun 26, 2026Migration or Expulsion of Device; Patient Device Interaction Problem

  It was reported on (b)(6) 2026 a 16 mm Amplatzer Amulet Left Atrial Appendage Occluder was selected for implant using a 12F Amulet delivery sheath for a left atrial appendage (LAA) closure. Prior to procedure, the patient was taking Clopidogrel. The imaging modality used was transesophageal echocardiogram (TEE). The landing zone measurements were: 0 degrees, 13.9 mm, 45 degrees, 14.4 mm, 90 degrees, 13.1 mm, and 135 degrees, 14.3. The LAA was windsock shaped. The left atrial pressure was above 12 mmHg. The activating clotting time was 320 seconds and Heparin was given. During the procedure the patient's heart rhythm was normal sinus rhythm. The device was positioned resting on the pulmonary vein ridge. No leak was detected around the lobe. CLOSE criteria were satisfied and a tension test was performed. The device was implanted with a tire shape noted. The patient continued Clopidogrel after the procedure. At the 45-day post op follow up, TEE confirmed that the disc had shifted from the pulmonary vein ridge and appeared to be lodged in a depression on the anterior side at 135 degrees. Thrombus was confirmed at the position where the disc was lodged. Because the disc had dropped to t

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25638651 ↗
• InjuryDec 16, 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 16 MM AMPLATZER AMULET WAS IMPLANTED USING AN 14F AMULET DELIVERY SYSTEM. THE CLINICAL INDICATION FOR IMPLANTING THE AMPLATZER AMULET IN THIS PATIENT WAS HIGH BLEEDING RISK. THE PATIENT WAS REPORTED TO BE STABLE IMMEDIATELY PRIOR TO THE IMPLANT PROCEDURE, AND THE BASELINE RHYTHM WAS NORMAL SINUS RHYTHM (NSR) AT THE BEGINNING OF THE PROCEDURE. IDEVICE SIZING MEASUREMENTS WERE OBTAINED USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND ANGIOGRAPHY, SUPPORTING SELECTION OF A 16 MM AMPLATZER AMULET DEVICE. DURING THE PROCEDURE, FOLLOWING ADMINISTRATION OF ANGIOGRAPHIC CONTRAST, THE PATIENT DEVELOPED HYPOTENSION AND A SLOWING HEART RATE. ELECTROCARDIOGRAM MONITORING REVEALED ST-SEGMENT ELEVATION IN LEADS II AND III. THE ST ELEVATION AND ONSET OF HEART BLOCK OCCURRED PRIOR TO DEVICE INSERTION. THE TIMING OF THE MYOCARDIAL INFARCTION WAS REPORTED AS ST-SEGMENT ELEVATION NOTED AFTER CONTRAST INJECTION THROUGH THE PIGTAIL DURING ANGIOGRAPHY OF THE APPENDAGE, WITH THE PATIENT HAVING BEEN STABLE UNTIL THIS POINT. SUPPLEMENTAL OXYGEN WAS PROVIDED, AND 100 MCG OF NEO (PHENYLEPHRINE) WAS ADMINISTERED TO SUPPORT BLOOD PRESSURE, RESULTING IN BRIEF IMPROVEMENT. ALT

  Patient problems: Bradycardia; Heart Block; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Pericardial Effusion

  MAUDE report 23824973 ↗
• InjuryOct 28, 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 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED IN THE PATIENT. AFTER THE AMULET PROCEDURE, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS DONE ON THE RIGHT CORONARY ARTERY (RCA). THE PATIENT'S BLOOD PRESSURE WAS DROPPED AND HAD TENDERNESS IN ABDOMEN. THE PATIENT WAS TAKE FOR A COMPUTED TOMOGRAPHY (CT) AND WENT ASYSTOLE. A CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, PATIENT STABILIZED AND WENT BACK TO CARDIAC CATHETERIZATION LAB FOR FURTHER TESTING. IT WAS DETERMINED THAT PATIENT HAD A RETROPERITONEAL (RP) BLEED FROM THE ARTERIAL STICK NOT THE VENOUS STICK. AS PER PHYSICIAN THIS WAS NOT RELATED TO AMULET IMPLANT. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 23403997 ↗
• InjuryJul 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM SIZE AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED IN THE PATIENT USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. ON (B)(6) 2025, THE PATIENT PRESENTED WITH LATE EFFUSION. THE CAUSE OF EFFUSION WAS AMULET

  Patient problems: Angina; Dyspnea; Pericardial Effusion

  MAUDE report 22484753 ↗
• InjuryMay 22, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT. THE PATIENT'S LANDING ZONE MEASUREMENTS UNDER THE FOLLOWING VIEWS WERE: 10.9MM AT 0 DEGREES, 11.3MM AT 45 DEGREES, 11.1MM AT 90 DEGREES, AND 12.4MM AT 135 DEGREES. TRANSESOPHAGEAL ECHOCARDIOGRAM AND ANGIOGRAPHY WERE USED TO DETERMINE DEVICE SIZING AND WERE ALSO USED INTERPROCEDURALLY. DURING THE PROCEDURE THE OCCLUDER WAS REPOSITIONED MULTIPLE TIMES. CLOSE CRITERIA WERE MET. A TENSION TEST WAS PERFORMED. THE PATIENT'S LEFT ATRIAL PRESSURE WAS ABOVE 12 MMHG. 500ML OF HEPARIN WAS ADMINISTERED. THE OCCLUDER HAD A BARREL-SHAPED COMPRESSION. THE OCCLUDER WAS IMPLANTED. ON (B)(6) 2025 DURING A POST-PROCEDURE TRANSTHORACIC ECHOCARDIOGRAM (TTE) THE POSITION OF THE OCCLUDER COULD NOT BE CONFIRMED. AN X-RAY CONFIRMED THE OCCLUDER EMBOLIZED TO THE AORTA. ON (B)(6) 2025, THE OCCLUDER WAS SNARED AND REMOVED FROM THE PATIENT. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071940 ↗
• InjuryApr 22, 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 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 12F TORQUE DELIVERY SYSTEM. DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS 12MMHG, ACTIVATED CLOTTING LEVELS WERE 350S AND 12,000 UNITS OF HEPARIN WAS ADMINISTERED. THE AMULET WAS SUCCESSFULLY IMPLANTED AFTER SINGLE DEPLOYMENT. NEXT DAY, A VERY SMALL EFFUSION AND CARDIAC TAMPONADE WERE NOTED. THE PATIENT STARTED TAKING ACETYLSALICYLIC ACID (ASA) AND RESOLVED THE ISSUE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21883264 ↗
• InjuryMar 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 12F TORQVUE 45X45 DELIVERY SYSTEM. PATIENT PRESENTED IN ATRIAL FIBRILLATION. TRANSSEPTAL PUNCTURE WAS INFERIOR, POSTERIOR. 10000 UNITS HEPARIN WAS ADMINISTERED AND ACTIVATED CLOTTING TIME WAS GREATER THAN 280. IMPLANTATION WAS VERY DIFFICULT DUE TO ANATOMY ALONG WITH POOR IMAGING QUALITY. DEVICE WAS PARTIALLY RECAPTURED TWICE. WHEN ATTEMPTING TO IMPLANT THE DEVICE, LOCALIZED PERICARDIAL EFFUSION WAS OBSERVED AT THE LAA. CARDIAC TAMPONADE WAS PRESENT. THE PROCEDURE WAS ABANDONED AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS REPORTED TO BE STABLE. IN THE PHYSICIAN'S OPINION THE AMULET SYSTEM HAD CAUSED THE PERICARDIAL EFFUSION.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21652738 ↗
• MalfunctionMar 10, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 16MM AMPLATZER AMULET WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE OCCLUDER WAS FOUND TO NOT TAKE THE PROPER SHAPE. THE DEVICE WASN'T IMPLANTED AND THE PATIENT WAS CONVERTED FOR SURGICAL CLOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561302 ↗
• InjuryFeb 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SYSTEM. PATIENT PRESENTED IN SINUS RHYTHM WITH LEFT ATRIAL PRESSURE OF 9MM HG. HEPARIN WAS ADMINISTERED AS ANTICOAGULANT, MAINTAINING A MINIMUM 257 ACTIVATED CLOTTING TIME. THE OCCLUDER WAS IMPLANTED SUCCESSFULLY WITHOUT RECAPTURES OR MULTIPLE MANIPULATIONS. THERE WERE NO WIRES PLACED IN THE LAA OR PULMONARY VEINS. ON (B)(6) 2023, AT THE DISCHARGE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) A 4MM WIDTH PERICARDIAL EFFUSION WAS OBSERVED. THE EFFUSION WAS CONSIDERED TRIVIAL BY THE PHYSICIAN AND NO HEMODYNAMIC COMPROMISE WAS OBSERVED. NO TREATMENT WAS PERFORMED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Pericardial Effusion

  MAUDE report 21388359 ↗
• InjuryJan 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM 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 THE AMULET WAS SUCCESSFULLY IMPLANTED AFTER SOME MANIPULATIONS. ON (B)(6) 2024, THE PHYSICIAN MENTIONED THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON AN UNKNOWN DAY WITH CHEST PAIN AND A SMALL PERICARDIAL EFFUSION WAS DETECTED AND MEDICATION WAS ADMINISTERED. THE PHYSICIAN MENTIONED THE CAUSE OF EFFUSION WAS ABBOTT DEVICE, THE PATIENT WAS REPORTED STABLE.

  Patient problems: Angina; Pericardial Effusion

  MAUDE report 21126172 ↗
• DeathNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER AMULET WAS SELECTED FOR IMPLANT USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT WAS IN STABLE CONDITION PRIOR TO PROCEDURE. ZERO RECAPTURES WERE PERFORMED. A TENSION TEST WAS PERFORMED FOR STABILITY AND THE CLOSE CRITERIA WAS MET. THE AMULET WAS SUCCESSFULLY IMPLANT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND WAS REPORTED TO BE IN STABLE CONDITION. ON (B)(6) 2024, TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND NO CLINICAL FINDINGS WERE REPORTED. THE PATIENT WAS THEN DISCHARGED HOME IN STABLE CONDITION. LATER THAT EVENING, IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARREST AND PASSED. IT WAS REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN, HOWEVER THE PHYSICIAN BELIEVED THIS COULD BE RELATED TO A PULMONARY EMBOLISM DUE TO THE PATIENTS PRE-EXITING PULMONARY ISSUES AND CO-MORBIDITIES.

  Patient problems: Cardiac Arrest; Pulmonary Embolism

  MAUDE report 20678403 ↗
• MalfunctionOct 4, 2024Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED. THE LANDING ZONE MEASUREMENTS AT 0 DEGREES, 45 DEGREES, 90 DEGREES, AND 135 DEGREES WERE 12MM, 12MM, 11MM, AND 17MM, RESPECTIVELY. INTRACARDIAC ECHOCARDIOGRAPHY (ICE) MEASURED THE LANDING ZONE AT 14MM. MEASUREMENTS WERE TAKEN AS WELL AS TAKING PECTINATE MUSCLE INTO CONSIDERATION. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND ICE WERE USED DURING THE PROCEDURE. THE LEFT ATRIAL PRESSURE WAS 9MMHG, AND FLUID WAS PROVIDED. THEN, THE LEFT ATRIAL PRESSURE WAS MEASURED AT 12MMHG. THE DEVICE HAD A TIRE SHAPE COMPRESSION. THE CLOSE CRITERIA WERE SATISFIED, AND A TENSION TEST WAS PERFORMED. THERE WAS NO DIFFICULTY IMPLANTING THE DEVICE. THERE WAS NO LEAK DETECTED AROUND THE LOBE OF THE DEVICE ONCE IMPLANTED. AT A 45 DAY FOLLOW UP, A TEE WAS PERFORMED, WHICH SHOWED THAT THE DEVICE MAY HAVE MIGRATED FROM ITS INITIAL POSITION, CAUSING A LEAK. THE PATIENT DID NOT HAVE ANY CLINICAL SIGNS OR SYMPTOMS. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED. THE DEVICE WAS DETERMINED TO BE STABLE, SO THE PATIENT WAS KEPT ON ORAL ANTICOAGULATION. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20368359 ↗
• InjurySep 30, 2024Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2024, AN 16 MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 8880820) WAS CHOSEN FOR IMPLANTATION UTILIZING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEVICE WAS IMPLANTED SUCCESSFULLY WITH ONE FULL RECAPTURE. POST PROCEDURE THE SAME DAY, TRACE PERICARDIAL EFFUSION WAS OBSERVED. PATIENT WAS ASYMPTOMATIC. UNSPECIFIED TREATMENT WAS PERFORMED. THE EFFUSION RESOLVED ON (B)(6) 2024.

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

  MAUDE report 20339675 ↗
• InjurySep 23, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  (B)(6) - CATALYST IDE, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT WITH A 12F AMPLATZER AMULET DELIVERY SHEATH. AT THE START OF PROCEDURE, THE PATIENT'S ATRIAL RHYTHM WAS AT ATRIAL FLUTTER. THE PATIENT'S LEFT ATRIAL APPENDAGE (LAA) DIMENSIONS WERE AS FOLLOWS: LAA DEPTH = 16MM, LAA ORIFICE = 13MM, LANDING ZONE = 11-13MM, AND LA PRESSURE = 9MMHG). THE PATIENT'S MOST RECENT INTERNATIONAL NORMALIZED RATIO (INR) WAS 1.0 ON (B)(6) 2024. DURING PROCEDURE, HEPARIN WAS ADMINISTERED AND THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS RANGED 212-289 SECONDS. DURING PROCEDURE, THERE WERE 3 PARTIAL RECAPTURES BEFORE THE 16MM AMPLATZER AMULET WAS COMPLETELY RECAPTURED PRIOR TO RELEASE FROM THE DELIVERY CABLE AND REMOVED FROM THE PATIENT. IT WAS THEN DECIDED TO ATTEMPT AN IMPLANT WITH AN 18MM AMPLATZER AMULET BUT IT WAS ALSO UNSUCCESSFUL DUE "SPONTANEOUS DISLOCATION AND OVER-COMPRESSION BECAUSE OF SIZED MIS-MATCH" AND WAS SUBSEQUENTLY RECAPTURED PRIOR TO RELEASE FROM THE DELIVERY CABLE AND REPLACED. A DECISION WAS MADE TO REUSE THE FIRST 16MM AMPLATZER AMULET BUT DURING DEVICE PREPARATION, IT WAS NO

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20278663 ↗
• MalfunctionAug 14, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR THE IMPLANT. DURING THE ADVANCING OF THE DEVICE INTO THE DELIVERY SHEATH, AT THE BEGINNING OF THE DELIVERY SHEATH, THE OPERATOR REALIZED THAT THE DEVICE WAS UNSCREWED. A COMPLETE DETACHMENT WAS NOTED THE PHYSICIAN MANAGED TO SCREW IT IN AND REMOVE IT FROM THE DELIVERY SHEATH AND THE PATIENT. THE PATIENT IS STABLE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983371 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. IS WAS NOTED THAT THE LEFT ATRIAL APPENDAGE (LAA) HAD A REVERSE CHICKEN WING SHAPE. THE PATIENT WAS IN SINUS RHYTHM DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS INFERIOR POSTERIOR. THE PATIENT'S ACTIVATING CLOTTING TIME (ACT) WAS LESS THAN 300 SEC. 8000 UNITS OF HEPARIN WERE ADMINISTERED. THE PATIENT'S LEFT ATRIAL PRESSURE WAS GREATER THAN 12MMHG. NO PERICARDIAL WAS NOTED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE NO RE-CAPTURES WERE REQUIRED. THERE WERE NO DIFFICULTIES NOTED WITH DEPLOYING THE DEVICE. THE DEVICE WAS IMPLANTED. 4 HOURS POST-IMPLANT A PERICARDIAL EFFUSION WAS DETECTED WHICH LED TO A CARDIAC TAMPONADE. THE CARDIAC TAMPONADE SURROUNDED THE HEART AND WAS 2MM FROM THE SUBCOSTAL PLANE. PERICARDIOCENTESIS WAS PERFORMED. UPON FURTHER REVIEW, IT WAS OBSERVED THAT THE PULMONARY ARTERY WAS VERY CLOSE TO THE DISTAL PART OF THE LOBE, WHICH WAS BELIEVED TO BE THE CAUSE OF THE CARDIAC TAMPONADE. THE PATIENT STATUS WAS STABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 19356513 ↗
• InjuryApr 3, 2024Migration or Expulsion of Device; Premature Separation; Migration or Expulsion of Device; Premature Separation

  IT WAS REPORTED THAT ON 12 MARCH 2024, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING AN 12F TORQVUE DELIVERY SYSTEM. LAA LANDING ZONE WAS 9X14MM DETERMINED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). DURING THE PROCEDURE, THE DELIVERY CABLE PREMATURELY DETACHED IMMEDIATELY AFTER BEING UNSHEATHED CAUSING THE DEVICE TO EMBOLIZE INTO THE LEFT ATRIUM. THE DEVICE WAS ATTEMPTED TO BE RETRIEVED VIA A TRANSCATHETER SNARE, BUT THIS PUSHED THE DEVICE INTO THE LEFT VENTRICLE AND THEN THE DESCENDING AORTA. THE DEVICE WAS THEN ABLE TO BE RETRIEVED. THERE WAS NO OBSTRUCTION OF BLOOD FLOW. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE RETRIEVAL WAS CONSIDERED AN EMERGENCY PROCEDURE. THERE WAS A DELAY THAT RESULTED IN NO PATIENT CONSEQUENCES. NO REPLACEMENT WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037931 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS CHOSEN FOR IMPLANT, 14F AMULET STEERABLE DELIVERY SHEATH. THE PATIENT WAS PRESENTED WITH SMALL PERICARDIAL EFFUSION PRIOR TO DEVICE ATTEMPT. PATIENT WAS IN SINUS RHYTHM WITH A CONTRACTILE APPENDAGE AND LARGE TRANSVERSE SINUS. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WAS 378. ESMOLOL WAS ADMINISTERED TO CONTROL HEART RATE DURING DEPLOYMENT. DURING THE PROCEDURE, A SECOND TRANSSEPTAL PUNCTURE WAS PERFORMED DUE TO INABILITY TO GET THE STEERABLE SHEATH COAXIAL ENOUGH FOR AN ORTHOGONAL DEPLOYMENT. IT WAS NOTED THAT THERE WAS DIFFICULTY IMPLANTING THE AMULET DEVICE, REQUIRING MULTIPLE DEPLOYMENT ATTEMPTS. ABOUT AN HOUR POST-PROCEDURE, THE PATIENT HAD A SMALL BLOOD PRESSURE DROP, WHICH HAD ALSO OCCURRED DURING PROCEDURE. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS DONE, AND MILDLY LARGER PERICARDIAL EFFUSION WAS NOTED. THE PATIENT WAS GIVEN COLCHICINE AND THE PERICARDIAL EFFUSION RESOLVED ON ITS OWN BY THE NEXT DAY. THE PATIENT WAS REPORTED TO BE STABLE AND WAS DISCHARGED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 19011321 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: (B)(4) PATIENT SITE ID: (B)(6) IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING AN 12F AMPLATZER TORQVUE DELIVERY SYSTEM. THE AMULET WAS SUCCESSFULLY IMPLANTED. DURING THE PROCEDURE, 4000 UNITS OF HEPARIN WAS PROVIDED AND THE ACTIVATED CLOTTING TIME (ACT) REMAINED AT 290 SECONDS. ON A POST PROCEDURE TRANSTHORACIC ECHOCARDIOGRAM (TTE), A SMALL, FREE-FLOWING PERICARDIAL EFFUSION WAS IDENTIFIED CIRCUMFERENTIAL TO THE HEART. MEASURING LARGEST ANTERIORLY AT 1.0CM. NO EVIDENCE OF RIGHT ATRIAL OR RIGHT VENTRICULAR COLLAPSE.. THERE WAS NO HEMODYNAMIC COMPROMISE. NO INTERVENTION WAS PERFORMED. TWO MORE TTE WERE PERFORMED UNTIL THE PATIENT WAS CONFIRMED TO BE STABLE AND WAS DISCHARGED.

  Patient problems: Pericardial Effusion

  MAUDE report 18937266 ↗
• InjuryFeb 29, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED IN A PATIENT. NO EFFUSION WAS NOTED PRIOR TO PROCEDURE, HOWEVER THE PATIENT DID HAVE A VERY LARGE FLUID-FILLED TRANSVERSE SINUS. (B)(4) UNITS HEPARIN GIVEN TOTAL DURING PROCEDURE. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS AT END OF PROCEDURE WAS 283 SECONDS. THERE WERE MULTIPLE RECAPTURES/REPOSITIONING DUE TO SHALLOW AND SMALL ANATOMY. 40MG OF PROTAMINE GIVEN AT THE END OF PROCEDURE. NO EFFUSION WAS NOTED POST PROCEDURE. PATIENT KEPT OVERNIGHT AND COMPLAINED OF ATYPICAL CHEST PAIN. MULTIPLE SURFACE ECHOCARDIOGRAM (ECHO) PERFORMED ON (B)(6) 2024, (B)(6) 2024, AND (B)(6) 2024 WERE NORMAL. ON (B)(6) 2024, PATIENT HAD DROP IN HEMOGLOBIN AND HEMATOCRIT. COMPUTER TOMOGRAPHY (CT) OF ABDOMEN AND PELVIS PERFORMED WHICH DID NOT SHOW ANY BLEEDS BUT DID SHOW MODERATE PERICARDIAL EFFUSION. ON (B)(6) 2024, PATIENT RECEIVED ANOTHER ECHO WHICH SHOWED A SMALL TO MODERATE EFFUSION. ON (B)(6) 2024, ECHO SHOWED AN EFFUSION LARGER THAN 2CM WITH BEGINNING SIGNS OF CARDIAC TAMPONADE, INCLUDING RIGHT ATRIUM (RA) COLLAPSE WITH INCREASED HEART RATE. PATIENT TAKEN TO CATHETER LAB FOR PERICARDIOC

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

  MAUDE report 18811016 ↗
• MalfunctionFeb 29, 2024Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT A 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LOT 8553355) WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. IT WAS NOTED TO BE DIFFICULT TO CONNECT THE LOADER OF THE AMULET OCCLUDER TO THE DELIVERY SHEATH. THE STOPCOCK WAS REPLACED WITH A ROTATING NON-ABBOTT STOPCOCK. THE DEVICE WAS DEPLOYED AND PLACED IN THE APPENDAGE. HOWEVER, DURING RELEASE OF THE DEVICE, THE DEVICE APPEARED TO BE SQUEEZE OUT OF THE APPENDAGE AND PARTIALLY MIGRATED. SINCE THE DEVICE HAD NOT YET BEEN FULLY RELEASED FROM THE DELIVERY CABLE, THE DEVICE WAS ABLE TO BE RETIGHTENED AND RECAPTURED. THE DEVICE WAS REPLACED WITH A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LOT 8553346) USING THE SAME DELIVERY SYSTEM. THE NON-ABBOTT STOPCOCK FROM PREVIOUS DEVICE WAS REMOVED AND SCREWED INTO THE 16MM AMPLATZER AMULET OCCLUDER LOADING SYSTEM. THE STOPCOCK CRACKED, ALLOWING AIR INTO THE SYSTEM. AIR WAS VISIBLE ON FLUOROSCOPY IN THE DELIVERY SHEATH. ASPIRATION WAS SUCCESSFULLY PERFORMED. NO AIR WAS VISIBLE IN THE PATIENT. THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE DEVICE WAS REPLACED WITH A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807400 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CLINICAL INFORMATION: CRD_1056 - ADVANCE LAA, PATIENT SITE ID: (B)(6) IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANTING USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE DEVICE WAS SIZED USING 2D TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND ANGIOGRAPHY. THE LANDING ZONE WAS MEASURED AS 13-14MM. THE APPENDAGE SHAPE WAS CHICKEN WING. HEPARIN WAS ADMINISTERED, AND THE ACTIVATED CLOTTING TIME (ACT) DURING THE PROCEDURE WAS 325 SECONDS. TEE AND FLUOROSCOPY WERE USED TO GUIDE THE PROCEDURE. THE AMULET OCCLUDER HAD 0 PARTIAL RECAPTURES AND 0 FULL RECAPTURES, AND THE DEVICE WAS IMPLANTED SUCCESSFULLY. PROTAMINE WAS ADMINISTERED TO REVERSE THE HEPARIN. THERE WERE NO REPORTED ADVERSE EVENTS DURING PROCEDURE. ON (B)(6) 2024, A TRIVIAL PERICARDIAL EFFUSION WAS SEEN ON 2D TRANSTHORACIC ECHOCARDIOGRAPHY (TTE). NO TREATMENT WAS REQUIRED. THE PATIENT STATUS WAS REPORTED AS STABLE.

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

  MAUDE report 18739784 ↗
• MalfunctionFeb 5, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR AN IMPLANT USING 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH (TV45X45). DURING THE PROCEDURE, WHEN THE WHEN THE DISK WAS DEPLOYED IT HAD A VERY CONTORTED SHAPE OBSERVED ON ECHOCARDIOGRAM AND FLURO. DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE CABLE. NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE PATIENT IS STABLE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646718 ↗
• MalfunctionDec 28, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN 18MM AMPLATZER AMULET WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING IMPLANT, IT WAS OBSERVED THAT THE DEVICE WAS UNABLE TO BE SUCCESSFULLY IMPLANTED DUE TO A MISSIZING. THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW 16MM AMPLATZER AMULET WAS SELECTED FOR IMPLANT. IT WAS OBSERVED THAT DURING THE PUSH AND PULL TEST IN THE DELIVERY SHEATH, THE DEVICE WAS NOT ATTACHED TO THE DELIVERY CABLE. THE PATIENT STATUS WAS NOTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416351 ↗