Amplatzer™ Amulet™ 9-ACP2-010-034Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00811806013527), received between Jul 14, 2020 and Sep 25, 2026 — classified as 6 deaths, 42 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (28 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 52 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Pericardial Effusion

  MAUDE report 50902964 ↗
• InjurySep 25, 2026Migration or Expulsion of Device

  It was reported that on (b)(6) 2026, a 34mm Amplatzer Amulet Left Atrial Appendage Occluder was chosen for a procedure using a 14F non-Abbott delivery system. The left atrial pressure at time of procedure was 16 mm/Hg. A non-Abbott device failed and physician chose 34mm Amulet as per transesophageal echocardiogram (TEE) and an angiography (angio). During procedure, the first deployment met CLOSE criteria but pulled out on tension test. The Amulet recaptured and redeployed with different orientation, met CLOSE criteria and did two, lengthy tension tests without movement. The device compression wasn¿t typical in the RAO/CAUD, so we changed the camera angle to the Right Anterior Oblique with cranial angulation (RAO/CRAN) and compression was Barrel/Roman Helmet. The Amulet looked good on release. Later in the day, it was reported that the Amulet had dislodged from appendage. The implanter believes the cause of embolization was the not typical compression in the Right Anterior Oblique with Caudal angulation (RAO/CAUD). They were able to snare the device out of the left atrium with no patient impact. The patient was stable throughout and left the Cath Lab in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897154 ↗
• InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 34 MM AMPLATZER AMULET WAS IMPLANTED USING A 14F AMULET DELIVERY SHEATH. THE TRANSSEPTAL PUNCTURE WAS PERFORMED IN AN INFERIOR AND POSTERIOR LOCATION. A FEW HOURS LATER, PERICARDIAL EFFUSION WAS NOTED, AND PERICARDIOCENTESIS WAS PERFORMED. THE EFFUSION WAS CIRCUMFERENTIAL WITH THE LARGEST DIMENSION MEASURING 4 CM. CARDIAC TAMPONADE WAS CONCLUDED TO BE PRESENT. DURING THE PROCEDURE, THE PATIENT¿S ACTIVATED CLOTTING TIME (ACT) WAS 320, AND 5000 UI OF HEPARIN WAS ADMINISTERED. THERE WAS NO DIFFICULTY IMPLANTING THE DEVICE, AND NO MULTIPLE MANIPULATIONS WERE REPORTED. THE PATIENT WAS TAKING CLOPIDOGREL BOTH PRIOR TO AND AT THE TIME THE EFFUSION WAS DETECTED. THE PATIENT WAS IN ATRIAL FIBRILLATION DURING THE PROCEDURE. THERE WERE NO MULTIPLE WIRE OR DELIVERY SHEATH EXCHANGES, AND THE WIRE POSITION WAS IN THE LEFT UPPER PULMONARY VEIN. THE LEFT ATRIAL PRESSURE AT THE TIME OF THE PROCEDURE WAS 11 MMHG. THE USER BELIEVES AN ABBOTT DEVICE CAUSED THE PERICARDIAL EFFUSION. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 23729568 ↗
• InjurySep 29, 2025Migration or Expulsion of Device; Separation Problem; Migration or Expulsion of Device; Separation Problem

  IT WAS REPORTED ON (B)(6)2025 A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT. THE PATIENT HAD MODERATE TO COMPLEX ANATOMY WITH A HEAVILY PICTINATED LEFT ATRIAL APPENDAGE. THE PATIENT'S LANDING ZONE MEASUREMENTS WERE MEASURED UNDER THE FOLLOWING VIEWS: 24MM AT 0 DEGREES, 25MM AT 45 DEGREES, 23MM AT 90 DEGREES, AND 31MM AT 135 DEGREES. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS USED DURING THE PROCEDURE. DURING THE PROCEDURE THE OCCLUDER WAS DETERMINED TO BE TOO SMALL IN SIZE. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND SIZED UP TO A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. THE SECOND OCCLUDER SHOWED ADEQUATE COMPRESSION. CLOSE CRITERIA WERE MET. A TENSION TEST WAS PERFORMED, HOWEVER THE OCCLUDER ANCHORS WERE NOT ENGAGED. THE OCCLUDER WAS IMPLANTED. THE FOLLOWING DAY THE PATIENT FELT LIGHT-HEADED AND PRESENTED WITH HYPOTENSION AND INTERMITTED PREMATURE VENTRICULAR CONTRACTIONS. ECHOCARDIOGRAM SHOWED THE OCCLUDER EMBOLIZED TO THE MITRAL APPARATUS AND CAUSED A PARTIAL BLOCKAGE LEADING TO ACUTE MITRAL REGURGITATION. THE OCCLUDER WAS SNARED VIA TRANSCATHETER FORCEPS AND REMOVED FROM THE PATIENT. ON (B)(6)2025 A MITRACLIP WAS IMPLANTED. THE PA

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension; Mitral Valve Insufficiency/ Regurgitation; Obstruction/Occlusion

  MAUDE report 23168567 ↗
• InjurySep 5, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE USING A 14F DELIVERY SYSTEM. THE LANDING ZONE MEASUREMENTS WERE AREA 585.3 MM² AND PERIMETER 86.7 MM. THE SIZING OF THE DEVICE WAS DETERMINED BY FEOPS HEARTGUIDE WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TOE/TEE). DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS ABOVE 12MMHG AND APPROXIMATELY 1 LITER OF FLUID WAS GIVEN. THE DEVICE WAS POSITIONED CORRECTLY IN LAA, ALL CLOSE SIGN OBSERVED, TUG TEST PERFORMED ADEQUATELY AND THE AMULET DETACHED WITHOUT ANY ISSUE. THE DEVICE COMPRESSION WAS IN A ROMAN HELMET SHAPE. SIX HOURS AFTER PROCEDURE, THE PATIENT EXPERIENCED NAUSEA AND A FLUTTERING IN HIS CHEST, TEE CONFIRMED THE DEVICE WAS EMBOLIZED TO THE MITRAL VALVE AND REQUIRING AN IMMEDIATE SURGICAL INTERVENTION. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Atrial Flutter; Nausea

  MAUDE report 22977159 ↗
• InjuryAug 26, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER AMULET DELIVERY SHEATH. THE DEVICE SIZING WAS DETERMINED USING A 3D PRINTING SIMULATOR AND 3MENSIO SOFTWARE. DURING PROCEDURE, THE ANCHORING WAS CONFIRMED ON THE AMULET DEVICE AND DEPLOYED. THE CLOSE CRITERIA WAS PERFORMED AND TENSION TEST PERFORMED MULTIPLE ATTEMPTS. THE DEVICE COMPRESSION WAS IN A ROMAN HELMET SHAPE. ONE DAY AFTER THE PROCEDURE, ON FOLLOW UP IMAGING IT WAS NOTED THE AMULET WAS COMPLETELY DISLODGED INTO THE LEFT ATRIAL SPACE. THE AMULET WAS SURGICALLY REMOVED. THE PHYSICIAN MENTIONED THE CAUSE OF EFFUSION WAS SIZING ISSUES. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898575 ↗
• InjuryAug 18, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025 A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMULET DELIVERY SHEATH. THE PATIENT HAD A WINDSOCK-SHAPED LEFT ATRIAL APPENDAGE (LAA) MORPHOLOGY, CHARACTERIZED BY DISTAL NARROWING. THE LANDING ZONE WAS MEASURED UNDER THE FOLLOWING VIEWS: 27MM AT 0 DEGREES, 27MM AT 45 DEGREES, AND 28MM AT 90 DEGREES. ECHOCARDIOGRAM AND ANGIOGRAPHY WERE USED DURING THE PROCEDURE. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 7MMHG. DURING THE PROCEDURE THE OCCLUDER WAS RE-SHEATHED TWICE. THE FINAL PLACEMENT WAS PROXIMAL AND CLOSE CRITERIA WERE MET, HOWEVER THERE WAS SOME CONCERN ABOUT THE PROXIMAL POSITION AND UNDERFILLING OF THE PATIENT. THE OCCLUDER HAD BARREL-SHAPED COMPRESSION. THE LOBE OF THE OCCLUDER WAS POSITIONED APPROXIMATELY 2-3MM BEHIND THE CIRCUMFLEX ARTERY (CX). UPON RELEASE OF THE OCCLUDER, THE OCCLUDER EMBOLIZED TO THE MITRAL VALVE AND CAUSED A PARTIAL BLOCKAGE. THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY FOR EXPLANT OF THE OCCLUDER. THE PATIENT STATUS WAS STABLE. PER THE PHYSICIAN, THE DEVICE EMBOLIZATION WAS DUE TO POOR IMAGING QUALITY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22828603 ↗
• InjuryMay 21, 2025Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 31MM AMPLATZER AMULET OCCLUDER WAS SELECTED FOR IMPLANT IN A PATIENT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT WAS ADMINISTERED 8,000 UNITS OF HEPARIN FOR PROCEDURE. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 298 SECONDS BEFORE IMPLANTING THE OCCLUDER. IT WAS NOTED DURING THE PROCEDURE, THAT THE 31MM AMPLATZER AMULET OCCLUDER WAS TOO SMALL. THE DECISION WAS MADE TO FULLY RECAPTURE THE 31MM AMPLATZER AMULET OCCLUDER AND REPLACE IT WITH A 34MM AMPLATZER AMULET OCCLUDER TO COMPLETE THE PROCEDURE, USING THE SAME DELIVERY SHEATH. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH WAS NOT IN THE PATIENT FOR A SIGNIFICANT PERIOD OF TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. POST-IMPLANT, IT WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM THAT A POTENTIAL NEW THROMBUS WAS SEEN ADHERING TO THE DISC OF THE OCCLUDER IN THE LEFT ATRIUM. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) CLOSEST TO THE TIME OF THE REPORTED THROMBUS IS UNKNOWN. IT'S NOTED THAT THE PATIENT WAS ON ELIQUIS PRIOR TO THE PROCEDURE. THE DECISION WAS MADE T

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22066444 ↗
• InjuryApr 25, 2025Difficult to Fold, Unfold or Collapse; Patient-Device Incompatibility; Difficult to Fold, Unfold or Collapse; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR A LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PROCEDURE USING A 12F AMPLATZER AMULET DELIVERY SHEATH. DURING PROCEDURE, THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE 316 AND 10000 UNITS OF HEPARIN WAS ADMINISTERED. THE AMULET WAS SUCCESSFULLY IMPLANTED. THE DAY AFTER THE PROCEDURE, DURING THE CONTROL ECHOCARDIOGRAM (ECHO) AFTER LAAO CLOSURE, IT WAS NOTICED THAT THE DISC LOOKED AS IF IT WAS BEING PULLED ALL THE TIME AND THE SHAPE OF THE DISC WAS UNNORMAL. THE PATIENT HAD CHEST PAIN, ELEVATED TROPONIN AND A PERICARDIAL EFFUSION AND TAMPONADE WERE NOTED. A THE PERICARDIOCENTESIS WAS PERFORMED AND 200 ML OF BLOOD WAS ASPIRATED. THE PHYSICIAN MENTIONED ABBOTT DEVICE CAUSED TAMPONADE. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Angina; Cardiac Enzyme Elevation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21910008 ↗
• MalfunctionApr 22, 2025Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 28MM AMPLATZER AMULET WAS SELECTED FOR USE IN AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT THE DEVICE WASN'T ABLE TO FIT AND WAS REMOVED. THE DECISION WAS TO UPSIZE TO 34MM AMPLATZER AMULET WITH THE SAME DS BEING USED. IT WAS NOTED THAT A BACK BLEEDING WAS PERFORMED ON THE DS. THE 34MM DEVICE WAS PREPPED AND DELIVERED TO THE IMPLANT SITE. ONCE IN THE BALL FORMATION, SOMETHING UNKNOWN WAS NOTED ON TEE. THE DECISION WAS TO RESHEATH THE DEVICE AND ABANDON THE PROCEDURE. EXAMINATION OF THE 34MM DEVICE REVEALED A THIN STRAND OF STRINGY MATERIAL. THERE WERE NO ADVERSE EVENTS TO THE PATIENT AND THEIR ACT WAS NOTED TO BE 326. THERE WAS 2 RESHEATH ATTEMPTS ON THE 28MM DEVICE AND 1 RESHEATH ATTEMPT ON THE 34MM DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885852 ↗
• DeathApr 21, 2025Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED ON (B)(6) 2025 A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH TO TREAT A LEFT ATRIAL APPENDAGE (LAA). THE PATIENT'S LAA WAS MEASURED UNDER THE FOLLOWING VIEWS: 24MM AT 0 DEGREES, 20MM AT 45 DEGREES, 22MM AT 90 DEGREES, AND 19MM AT 135 DEGREES. THE LANDING ZONE WAS MEASURED AT 27MM UNDER ANGIOGRAPHY IN RIGHT ANTERIOR OBLIQUE (RAO). TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS USED DURING THE PROCEDURE. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 12 MMHG. DURING THE PROCEDURE THE OCCLUDER WAS PARTIALLY RE-CAPTURED MULTIPLE TIMES. THE OCCLUDER WAS REMOVED FROM THE PATIENT AND RE-SIZED TO A NEW 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. THE OCCLUDER WAS DEPLOYED. IT WAS NOTED THAT THERE WAS A 30-40% MITRAL SHOULDER IN THE HIGH TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) ANGLE AND MINIMAL SEPARATION BETWEEN THE LOBE AND THE DISC. DUE TO THIS CLOSE CRITERIA WERE NOT COMPLETELY MET. THERE WAS VISIBLE COMPRESSION ON THE LOBE IN THE SHAPE OF A TIRE. THE END SCREW OFFSET AND THE OCCLUDER DID NOT MOVE OR MIGRATE DURING A TUG TEST. THE OCCLUDER WAS RELEASED FROM THE DELIVERY CABLE. A LEAK WAS OBSE

  Patient problems: Angina; Cardiac Arrest; Obstruction/Occlusion

  MAUDE report 21875034 ↗
• InjuryApr 10, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025 A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMULET DELIVERY SYSTEM TO TREAT A LEFT ATRIAL APPENDAGE (LAA). THE PATIENT HAD A PRE-EXISTING ATRIAL FIBRILLATION. SIZING OF THE DEVICE WAS DETERMINED WITH CARDIAC COMPUTED TOMOGRAPHY (CT). TRANSSEPTAL PUNCTURE WAS NOTED TO BE DIFFICULT AND WAS DONE IN THE MIDDLE OF THE FOSSA OVALIS. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 280 SECONDS. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 15MMHG. 100 UNITS OF HEPARIN WERE ADMINISTERED. IT WAS NOTED THAT THERE WAS DIFFICULTY IMPLANTING THE OCCLUDER. THE AXIS TO DELIVER THE OCCLUDER WAS NOT OPTIMAL. THE OCCLUDER WAS PARTIALLY RE-CAPTURED THREE TIMES. AFTER RELEASE OF THE OCCLUDER FROM THE DELIVERY CABLE, A PERICARDIAL EFFUSION WAS VISUALIZED ON TRANSTHORACIC ECHOCARDIOGRAM (TTE). A POSTERIOR PUNCTURE WAS NOTED. THE PERICARDIAL EFFUSION LED TO A CARDIAC TAMPONADE. THE PATIENT'S BLOOD PRESSURE DECREASED SLOWLY AND WAS LOW. THE PATIENT'S SYSTOLIC PRESSURE WAS 70 MMHG. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT BECAME HEMODYNAMICALLY STABLE. TWO HOURS POST-PROCEDURE ON TTE THERE WAS NO PERICARDIAL EFFUSION, HO

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 21816151 ↗
• InjuryApr 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON 11 MARCH 2025, A 34MM AMPLATZER AMULET OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER AMULET DELIVERY SHEATH. IT WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM WHILE INSERTING AND MANEUVERING THE OCCLUDER AND DELIVERY SHEATH, THAT A FIBROUS THROMBUS WAS DETECTED IN THE DISTAL PART OF THE DELIVERY SHEATH WHILE IN THE LEFT UPPER PULMONARY VEIN. NO THREADS WERE SHOWING. THE PATIENT HAD BEEN INITIALLY ADMINISTERED 5000 UNITS OF HEPARIN FOR PROCEDURE AND HAD AN ACTIVATED CLOTTING TIME LEVEL OF 227 SECONDS. AN ADDITIONAL 4000 UNITS WERE GIVEN, AND AFTER CONFIRMING THE PRESENCE OF A THROMBUS, A FURTHER 6000 UNITS WERE ADMINISTERED. THE 34MM AMPLATZER AMULET OCCLUDER AND 14F AMPLATZER AMULET DELIVERY SHEATH WERE REMOVED. IT'S NOTED THAT THE DELIVERY SHEATH HAD BEEN IN THE PATIENT FOR 60 MINUTES. AFTER REMOVAL IT WAS NOTED THAT THROMBUS WAS SEEN ALSO ADHERING TO THE OCCLUDER. A REPLACEMENT 31MM AMPLATZER AMULET OCCLUDER AND 14F AMPLATZER AMULET DELIVERY SHEATH WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT DOES NOT HAVE ANY HEMATOLOGIC DISORDERS OR SYSTEMIC ILLNESS THAT COULD CONTRIBUTE TO A HYPERCOAGULABILITY. THERE WAS NO INITIAL OR PROLONGED HOSPITALIZATI

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21773679 ↗
• MalfunctionMar 31, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON (B)(6) 2025 A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT USING A 14F AMULET DELIVERY SHEATH. THE DIMENSIONS OF THE LEFT ATRIAL APPENDAGE (LAA) UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WERE A 20MM MINIMUM AND A 32MM MAXIMUM. ANGIOGRAPHY AND TEE WERE USED DURING THE PROCEDURE. DURING THE PROCEDURE THE OCCLUDER WAS PARTIALLY RE-CAPTURED TWICE. THE PATIENT HAD COMPLEX ANATOMY. THE OCCLUDER WAS IMPLANTED. THREE MONTHS POST-PROCEDURE DURING A FOLLOW-UP IT WAS NOTED THAT THE OCCLUDER ROTATED IN THE LEFT ATRIUM AND APPROXIMATELY 50% OF THE OCCLUDER WAS OUTSIDE THE LEFT ATRIUM. THE PHYSICIAN BELIEVED THE AXIS OF THE OCCLUDER MAY NOT HAVE BEEN COMPLETELY ALIGNED DUE TO THE PATIENT'S COMPLEX ANATOMY. SOME OF THE HOOKS MAY HAVE NOT BEEN PROPERLY ANCHORED, HOWEVER THIS WAS UNABLE TO BE SEEN THROUGH TEE DURING THE PROCEDURE. 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 21733096 ↗
• InjuryJan 23, 2025Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON 27 DECEMBER 2024, A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE SIZING OF THE DEVICE WAS DETERMINED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). A RE-SIZING OF THE DEVICE WAS PERFORMED FORM 31MM TO 34MM AND FOUR NON-ABBOTT DEVICES WERE ATTEMPTED. FINALLY A 34MM WAS SELECTED. DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS ABOVE 12MMHG, CLOSE CRITERIA WAS SATISFIED AND TENSION TEST WAS PERFORMED TWICE. THE 34 AMULET WAS SUCCESSFULLY IMPLANTED WITH THE SAME DELIVERY SYSTEM AND DEVICE COMPRESSION WAS IN A TIRE SHAPE. AFTER THE PROCEDURE, WHEN THE PATIENT WAS IN THE RECOVERY AREA, AN EMBOLIZATION OF THE AMULET DEVICE WAS NOTED IN TRANSTHORACIC ECHOCARDIOGRAM (TTE). THE DEVICE WAS STAYED IN THE LEFT ATRIUM. THE DEVICE GOT RETRIEVED VIA PERCUTANEOUS RETRIEVAL THROUGH THE GROIN FROM THE LEFT ATRIUM. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218650 ↗
• InjuryJan 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE PATIENT WAS IN SINUS RHYTHM. TRANSSEPTAL ACCESS WAS INFERIOR-POSTERIOR. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVEL WAS 310 SECONDS. THE PATIENT'S LEFT ATRIAL PRESSURE WAS 13MMHG. 8000 UNITS OF HEPARIN WERE ADMINISTERED. DURING THE PROCEDURE THE FIRST DEPLOYMENT ATTEMPT WAS UNSATISFACTORY AND THE DECISION WAS MADE TO PARTIALLY RE-CAPTURE THE OCCLUDER. IT WAS NOTED THERE WAS DIFFICULTY TO ENGAGE THE CENTRAL LOBE DUE TO THERE BEING 3 LOBES. DURING THE RE-CAPTURE A CIRCUMFERENTIAL CARDIAC TAMPONADE OCCURRED. THE DECISION WAS MADE TO RELEASE THE OCCLUDER IN THE LEFT ATRIAL APPENDAGE (LAA). A CONTINUOUS DRAINAGE OF THE PERICARDIAL EFFUSION WAS DONE UNTIL THE OCCLUDER WAS RELEASED. THE CARDIAC TAMPONADE STOPPED ON ITS OWN. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE USER BELIEVED THE OCCLUDER CAUSED THE PERICARDIAL EFFUSION. THE PATIENT STATUS WAS STABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 21069737 ↗
• InjuryDec 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON 18 OCTOBER 2024, A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER (LOT: 8951561) WAS CHOSEN FOR IMPLANTATION UTILIZING AN UNKNOWN DELIVERY SYSTEM. AT 45 DAY FOLLOW-UP ECHOCARDIOGRAM, A RESIDUAL LEAK WAS OBSERVED. THE APPENDAGE WAS MEASURED AT 29MM DURING THE INDEX PROCEDURE, BUT AT THE FOLLOW-UP IT WAS 36MM. PATIENT IS STABLE AND WAS ADMINISTERED ORAL ANTICOAGULANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939202 ↗
• InjuryDec 11, 2024Improper 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) 2024, A 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING PROCEDURE, THE ACTIVATED CLOTTING LEVELS WERE 250S, LEFT ATRIAL PRESSURE WAS 12MMHG AND HEPARIN WAS ADMINISTERED. THE 31MM AMULET WAS TRIED TO IMPLANT, BUT IT WAS PARTIALLY RECAPTURED AND COMPLETELY REMOVED BECAUSE THEY REQUIRED A LARGER DISC SIZE FOR THE PATIENT SO SIZED UP. A NEW 34MM AMULET WAS CHOSEN AND IMPLANTED WITH THE SAME DELIVERY SYSTEM AFTER A FULLY RECAPTURE. AT 45 DAY FOLLOW UP ECHOCARDIOGRAM (ECHO), PATIENT WAS NOTED TO HAVE A SMALL EFFUSION WITH NO SYMPTOMS. AFTER 30 DAYS, ON AN UNKNOWN DATE IN (B)(6) 2024, ANOTHER FOLLOW UP ECHO WAS COMPLETED TO MONITOR EFFUSION AND A PERICARDITIS/INFLAMMATION WAS NOTED. ON AN UNKNOWN DATE IN (B)(6) 2024, PATIENT PRESENTED TO EMERGENCY ROOM WITH CHEST PAIN AND SHORTNESS OF BREATH, A COMPUTED TOMOGRAPHY (CT) WAS DONE AND SENT TO CATHETERIZATION LABORATORY. ECHO IN THE LAB SHOWED LATERAL EFFUSION WITH BLOODY FLUID AND CARDIAC TAMPONADE, SO PATIENT WAS SENT TO THE OPERATING ROOM FOR A PERICARDIAL WINDOW WHERE APPROXIMATELY 400 CC OF FLUID WAS REMOVED. THE PATIENT

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

  MAUDE report 20906428 ↗
• MalfunctionNov 27, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 34MM AMPLATZER AMULET WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING PROCEDURE, THE DISC DEFORMED WITH A BULGING SHAPE. DESPITE SEVERAL ATTEMPTS TO CORRECT IT, THE DEFORMATION PERSISTED. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION/KINK WAS OBSERVED WITH THE DELIVERY SYSTEM. THE AMULET WAS NEVER RELEASED FROM THE DELIVERY CABLE AND WAS EXCHANGED FOR A NEW 31MM AMPLATZER AMULET, WHICH WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798881 ↗
• DeathNov 27, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT UTILIZING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE DEVICE SIZING WAS DETERMINED VIA COMPUTED TOMOGRAPHY (CT) SCAN AND INTRACARDIAC ECHOCARDIOGRAM (ICE). DURING THE PROCEDURE, ULTRASOUND AND ANGIOGRAPHY WERE USED. THE LEFT ATRIAL PRESSURE WAS 14MMHG. THE PROCEDURE WAS REPORTED TO BE VERY DIFFICULT. THE TRANSSEPTAL PUNCTURE WAS REPORTEDLY PERFORMED ABOVE THE INDICATED LOCATION, WHICH WAS WHY IT WAS MORE DIFFICULT TO PLACE THE DEVICE IN THE INDICATED POSITION. NOTHING ELSE UNUSUAL HAPPENED DURING THE CASE PER PHYSICIAN'S REPORT. ALL CLOSE SIGNS WERE MET, THE DEVICE REMAINED STABLE DURING THE TUG TEST, AND THE DEVICE WAS SUCCESSFULLY IMPLANTED. THE SHAPE OF THE DEVICE WAS TIRE. THERE WAS NO LEAKAGE AROUND THE DEVICE LOBE. ON (B)(6) 2024, IT WAS FOUND THAT THE DEVICE HAD EMBOLIZED AND WAS LODGING ITSELF IN THE PATIENT'S CARDIAC REGIONS. THE DEVICE WAS IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). THE PATIENT DID NOT HAVE ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT EMERGENTLY UNDERWENT HEART SURGERY TO REMOVE THE DEVICE. THE PATIENT WAS STABLE UNDER OBSERVATION IN

  Patient problems: Respiratory Insufficiency; Shock; Tachycardia

  MAUDE report 20791157 ↗
• DeathNov 15, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. THE LANDING ZONE MEASUREMENTS WERE BETWEEN 28 AND 29MM. THE SIZING OF THE DEVICE WAS DETERMINED WITH MEASUREMENTS ON ECHOCARDIOGRAPHY AND ANGIOGRAPHY. DURING THE PROCEDURE, ECHOCARDIOGRAPHY AND ANGIOGRAPHY WERE USED. THE LEFT ATRIAL PRESSURE WAS AROUND 15MMHG. THE DEVICE WAS DEPLOYED AND PARTIALLY RECAPTURED ONCE, AND IT HAD A TIRE COMPRESSION SHAPE. THE DEVICE MET THE CLOSE CRITERIA. A TENSION TEST WAS PERFORMED. THERE WAS A LEAK OF LESS THAN 1MM IN CORRESPONDENCE OF PULMONARY RIDGE. THE DEVICE WAS IMPLANTED. ON (B)(6) 2024, THE PATIENT SHOWED DISCOMFORT. ON ECHOCARDIOGRAM, IT WAS DISCOVERED THAT THE DEVICE HAD COMPLETELY EMBOLIZED AND WAS POSITIONED ON THE MITRAL VALVE, CAUSING A PARTIAL OBSTRUCTION. THE DEVICE WAS ATTEMPTED TO BE RETRIEVED VIA PERCUTANEOUS SNARE BUT WAS UNSUCCESSFUL. THE PATIENT WAS REFERRED TO CARDIAC SURGERY. THE DEVICE WAS SUCCESSFULLY EXPLANTED DURING SURGERY. AFTER CARDIAC SURGERY, THE PATIENT PASSED AWAY. THE CAUSE OF THE DEVICE EMBOLIZATION WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20698602 ↗
• InjuryNov 1, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. SIZING OF THE DEVICE WAS DETERMINED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND FLUOROSCOPIC MEASUREMENTS. THE LANDING ZONE MEASUREMENTS WERE AS FOLLOWS: 0 DEGREES: 27.5MM; 45 DEGREES: 21MM; 90 DEGREES: 26.3MM; 135 DEGREES: 28MM. TEE WAS USED DURING PROCEDURE. THE LEFT ATRIAL PRESSURE WAS ABOVE 12MMHG. VENOUS ACCESS WAS OBTAINED, AND THE INTERATRIAL SEPTUM WAS CROSSED THROUGH AN EXISTING PATENT FORAMEN OVALE (PFO). THE TRANSSEPTAL SHEATH WAS EXCHANGED FOR A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH, A PIGTAIL WAS INTRODUCED, AND THE SHEATH WAS POSITIONED IN THE LAA. THE DEVICE WAS PREPPED AND ADVANCED INTO THE LAA. THE DEVICE WAS DEPLOYED AND PARTIALLY RECAPTURED TWICE DUE TO DIFFICULT ANATOMY. A TENSION TEST WAS PERFORMED. THE DEVICE WAS COMPRESSED WITH DISTAL END SCREW OFFSET. THE DEVICE APPEARED TO MEET ALL CLOSE CRITERIA AND RELEASED FROM THE DELIVERY CABLE. AFTER RELEASE, THE DEVICE SHIFTED. APPROXIMATELY 2 MINUTES AFTER THE DEVICE WAS RELEASED, IT EMBOLIZED INTO THE LEFT ATRIUM (LA). TRANSSEPTAL ACCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20589769 ↗
• InjuryOct 8, 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 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT IN A PATIENT USING A 14F AMPLATZER AMULET DELIVERY SHEATH. PRIOR TO THE PROCEDURE, THE PATIENT HAD A TRIVIAL PERICARDIAL EFFUSION AND RECEIVED 325MG OF ASPIRIN BEFORE PROCEDURE. PATIENT WAS IN NORMAL SINUS RHYTHM. HEPARIN WAS ADMINISTERED WITH THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS AT 291 SECONDS. THE LOCATION OF THE TRANSSEPTAL PUNCTURE WAS INFERIOR/MID. THE LEFT ATRIAL PRESSURE WAS 22MMHG. THE DEVICE WAS IMPLANTED WITH NO RECAPTURES, AND THE DEVICE PLACEMENT AND CLOSURE WERE CONFIRMED BY TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). PROTAMINE WAS ADMINISTERED AT THE END OF PROCEDURE. THE PATIENT WAS DISCHARGED BUT RETURNED TO THE "HOSPITAL" THAT EVENING WITH A PULMONARY EMBOLISM AND A WORSENED CIRCUMFERENTIAL PERICARDIAL EFFUSION MEASURED AS 1.94MM. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE WITH TACHYCARDIA. A PERICARDIOCENTESIS WAS PERFORMED SUCCESSFULLY REMOVING 500CC OF FLUID AND A DRAIN WAS PLACED. INCREASED OXYGEN WAS GIVEN FOR PULMONARY EMBOLISM. THE PATIENT WAS DISCHARGED A WEEK LATER IN STABLE CONDITION. THE CAUSE OF THE PERICARDIAL EFFUSION WAS UNKNO

  Patient problems: Pericardial Effusion; Pulmonary Embolism

  MAUDE report 20398531 ↗
• InjurySep 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 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMULET STEERABLE DELIVERY SHEATH. THE AMULET WAS SUCCESSFULLY IMPLANTED. AFTER THE PROCEDURE, PRIOR TO DISCHARGE A MODERATE EFFUSION WAS OBSERVED IN THE INTENSIVE CARE UNIT (ICU) FOR A DAY AND THEN DISCHARGED. AFTER THAT, PATIENT APPEARED TO BE CONVERTED INTO ATRIAL FIBRILLATION (AF) AND WENT TO EMERGENCY ROOM (ER). A PERICARDIOCENTESIS WAS PERFORMED AND DRAINED 300CC. THE PATIENT WAS REPORTED STABLE.

  Patient problems: Atrial Fibrillation; Pericardial Effusion

  MAUDE report 20212727 ↗
• InjuryAug 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL INFORMATION: CRD_1056 - ADVANCE LAA, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON 05 JUNE 2024, A 34MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (9-ACP2-010-034) UTILIZING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM (9-TV45X45-14F-080). ON 20 JUNE 2024, THE PATIENT RETURNED TO HOSPITAL WITH LOWER EXTREMITY WEAKNESS. THROMBUS WAS OBSERVED ON THE DEVICE.

  Patient problems: Fatigue; Numbness; Stroke/CVA; Syncope/Fainting; Thrombosis/Thrombus

  MAUDE report 20066445 ↗