Amplatzer™ ASDS-14F-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05415067036025), received between Jun 11, 2022 and Apr 18, 2024 — classified as 1 death, 22 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (23 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Jun 12, 2023Open, Classified

   There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.

   Z-2110-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2024Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING A 14F AMPLATZER STEERABLE DELIVERY SHEATH. THE PATIENT HAD A PRE-EXISTING CONDITION OF ATRIAL FIBRILLATION AND WAS NOTED TO HAVE A SEVERELY ENLARGED LEFT ATRIAL APPENDAGE (LAA). THE LARGEST ORIFICE OF THE APPENDAGE WAS MEASURED AT 36MM. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE OVER 250 SECONDS. DURING IMPLANT, THE DEVICE WAS DETERMINED TO BE TOO SMALL AND WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. DURING IMPLANT IT WAS NOTED THAT THERE WERE ISSUE WITH AIR BUBBLES WITHIN THE SHEATH OF THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 31MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. THE DEVICE WAS RE-CAPTURED THREE TIMES TO POSITION THE DEVICE INTO AN IDEAL PLACE. THE DEVICE WAS IMPLANTED. UPON MEETING CLOSE CRITERIA, IT WAS NOTED THAT WHILE THERE WAS NO FLOW DETECTED PAST THE LOBE, THERE WAS SOME FLOW NOTED PAST THE DISC. IT WAS DETERMINED THAT THERE WAS NO WAY TO CLOSE THE GAP BETWEEN THE DISC AND THE COUMADIN RIDGE. A NEXT-SIZED UP DISC WOULD HAVE ENCRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134404 ↗
• MalfunctionJun 27, 2023Improper or Incorrect Procedure or Method; Air/Gas in Device; Improper or Incorrect Procedure or Method; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6)2023, A 14F AMPLATZER STEERABLE DELIVERY SHEATH WAS CHOSEN FOR PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA DURING PROCEDURE. THE SHEATH WAS PREPARED AND CONNECTED TO CONTINUOUS FLUSH PRIOR TO INSERTING INTO PATIENT. THE CONTINUOUS FLUSH WAS INTERRUPTED AS THERE WAS NOT ENOUGH PRESSURE ON THE FLUID BAG CONNECTED TO THE SHEATH. DURING MANIPULATION OF THE DEVICE, THERE WAS AN INCIDENCE OF AIR INGRESSION VIA THE HEMOSTASIS VALVE OF THE STEERABLE SHEATH. THE HEMOSTASIS VALVE WAS TEMPORARILY CLOSED, AND AIR WAS SEEN IN THE LOADER OF THE DEVICE. NO AIR WAS VISUALIZED IN THE PATIENT. NO ASPIRATION WAS PERFORMED. THE DEVICE WAS NOT REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213828 ↗
• MalfunctionJun 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER STEERABLE DELIVERY SHEATH. THE PATIENT WAS UNDER GENERAL ANESTHESIA DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ATTACHED TO THE SIDE PORT OF THE DELIVERY SHEATH. WHEN THE DELIVERY SHEATH WAS INTRODUCED TO THE PATIENT AND AFTER THE GUIDEWIRE WAS REMOVED, THE PATIENT NOTED TO HAVE ST SEGMENT ELEVATION. THERE WAS NO EXCESSIVE RESISTANCE OR DIFFICULTY NOTICED WHEN THE DELIVERY SYSTEM WAS INTRODUCED TO THE PATIENT. THE ST ELEVATION RESOLVED WITHOUT INTERVENTION AFTER A FEW MINUTES, AND THE PROCEDURE WAS CONTINUED. NO AIR EMBOLUS WAS OBSERVED IN THE PATIENT. ST ELEVATION WAS NOTED AGAIN AFTER THE AMULET OCCLUDER WAS INSERTED THROUGH THE DELIVERY SHEATH. THERE WAS NO EXCESSIVE RESISTANCE OR DIFFICULTY NOTICED WHEN THE DEVICE WAS PASSED THROUGH THE DELIVERY SHEATH. NO ASPIRATION WAS DONE ON THE DELIVERY SHEATH. THE PATIENT'S VITAL SIGNS WERE STABLE, AND THE ST ELEVATIONS RESOLVED AGAIN WITHOUT INTERVENTION. THE AMULET OCCLUDER WAS IMPLANTED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE AND DI

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 17149498 ↗
• InjuryJun 12, 2023Air/Gas in Device; Air/Gas in Device

  ABBOTT IS ISSUING THIS IMPORTANT FIELD SAFETY CORRECTIVE ACTION FOR THE AMPLATZER STEERABLE DELIVERY SHEATH (ASDS) DUE TO THE HEMOSTASIS VALVE. A COMPLAINT TREND HAS BEEN OBSERVED ON THE ASDS DEVICE RELATED TO AIR INGRESS. FLUID IS MANAGED VIA A HEMOSTASIS VALVE ON THE PROXIMAL END OF THE HANDLE. THE DESIGN OF THE HEMOSTASIS VALVE COMPONENT IS INTENDED TO FACILITATE BLOOD MANAGEMENT BY MINIMIZING BLOOD RETURN THROUGH THE DEVICE BUT IS NOT DESIGNED FOR AIR MANAGEMENT WHILE INSTEAD RELYING ON THE USER TO PRACTICE OPTIMAL FLUID MANAGEMENT TECHNIQUE. THE HEMOSTASIS VALVE HAS BEEN DETERMINED TO BE SENSITIVE TO CERTAIN PATIENT PHYSIOLOGICAL CONDITIONS AND USE SCENARIOS RESULTING IN A HIGHER-THAN-EXPECTED RATE OF ACTUAL AND POTENTIAL AIR EMBOLUS EXPERIENCES IN A LIMITED NUMBER OF USER ACCOUNTS.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 17114636 ↗
• MalfunctionJun 12, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 14F AMPLATZER STEERABLE DELIVERY SHEATH WAS CHOSEN FOR AN LEFT ATRIAL APPENDAGE IMPLANT PROCEDURE. DURING DEVICE PREPARATION, AIR BUBBLES WERE NOTICED IN THE HEMOSTASIS VALVE AFTER THE DILATOR WAS INSERTED INTO THE DELIVERY SHEATH. A DECISION WAS MADE TO REMOVE THE DILATOR AND DEVICE WAS FLUSHED AGAIN WITH SALINE WATER THROUGH THE FLUSHING PORT AND BYPASS HUB WITH THE HEMOSTASIS VALVE CLOSED. DURING FLUSHING, A CONTINUOUS WATER DRIP LEAK WAS SEEN FROM THE HEMOSTASIS VALVE KNOB. A DECISION WAS MADE TO REPLACE THE DELIVERY SYSTEM WITH A 12F AMPLATZER AMULET DELIVERY SHEATH. THE PROCEDURE CONTINUED WITH NO REPORT OF ADVERSE PATIENT CONSEQUENCES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT. IT WAS REPORTED THE ORIGINAL DELIVERY SYSTEM DID NOT MAKE PATIENT CONTACT. PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17114133 ↗
• InjuryJun 1, 2023Use of Device Problem; Use of Device Problem

  THE ARTICLE, "PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE WITH SUPERIOR VASCULAR ACCESS", WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY OF A 62 YEAR OLD MALE WHO REQUIRED A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DUE TO RECURRENT STROKES DESPITE BEING ON ANTICOAGULATION. PERCUTANEOUS VASCULAR ACCESS THROUGH THE LEFT AXILLARY VEIN WAS ATTEMPTED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED AT THE INFERO-POSTERIOR PART OF THE FOSSA OVALIS WITH THE A NON-ABBOTT WIRE/SHEATH (SUPRACROSS RF). A TRANSSEPTAL PUNCTURE SYSTEM CONSISTING OF A STEERABLE SHEATH AND RADIOFREQUENCY WIRE WITH A FLEXIBLE, SPIRAL TIP, TO OBTAIN ACCESS TO THE LEFT ATRIUM. AFTER GAINING LEFT ATRIAL ACCESS, AN AMPLATZER STEERABLE DELIVERY SHEATH (ASDS) WAS DELIVERED INTO THE LEFT ATRIUM. HOWEVER, DUE TO THE SUPERIOR ACCESS USED IN THIS PROCEDURE, THE ALIGNMENT OF THE ASDS WITH THE MAIN AXIS OF THE LAA WAS POSSIBLE ONLY AFTER DEFLECTING THE DISTAL ARTICULATION OF THE ASDS. A 31 MM AMPLATZER AMULET DEVICE WAS THEN SUCCESSFULLY RELEASED AFTER CONFIRMING PROPER DEVICE PLACEMENT USING BOTH FLUOROSCOPY AND ECHOCARDIOGRAPHY. A PERICARDIAL TAMPONADE WAS NOTED, A PROBABLE CONSEQUENCE OF THE HIGH FORCE APPLIED ON THE ASDS DURIN

  Patient problems: Pericardial Effusion

  MAUDE report 17036207 ↗
• InjuryMay 22, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6)2023, A 14F AMPLATZER STEERABLE DELIVERY SHEATH WAS SELECTED TO IMPLANT A DEVICE. DURING THE PROCEDURE, THERE WAS SUSPECTED AIR INGRESS THROUGH THE SHEATH CAUSING BUBBLE IN RIGHT CORONARY ARTERY (RCA) RESULTING IN TEMPORARY HYPOTENSION AND BRADYCARDIA, PATIENT RECOVERED WITH MEDICATION. THE DEVICE WAS USED TO CONTINUE THE PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 16976333 ↗
• MalfunctionMar 27, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 14F AMPLATZER STEERABLE DELIVERY SHEATH WAS SELECTED FOR PROCEDURE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS NOTED THAT AN INGRESS OF AIR WAS NOTED IN THE SHEATH. THE SEQUENCE OF EVENTS LEADING TO THE AIR EMBOLISM WAS STATED THAT FIRST, THE DILATOR WAS FLUSHED, THEN SHEATH WAS FLUSHED USING SIDE PORT. THEN THE SHEATH WAS CONNECTED TO CONTINUOUS PRESSURE FLUSH LINE AND DILATOR INSERTED. THEN THE SHEATH WAS INSERTED INTO PATIENT, THE DILATOR REMOVED AND THE PIGTAIL WAS ADVANCED. THE AIR EMBOLISM WAS IDENTIFIED THROUGH ANGIOGRAM. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION/TREATMENT DUE TO THE AIR EMBOLISM. ASPIRATION WAS NOT PERFORMED. IT WAS CONFIRMED THAT THERE WAS CONSTANT FLUSH THROUGH THE STEERABLE DELIVERY SHEATH'S SIDE PORT AND THAT CONTINUOUS FLUSH WAS NOT INTERRUPTED AT ANY POINT. THE DILATOR WAS NOT REMOVED TOO QUICKLY OR SLOWLY. THE LOADER WAS CONNECTED FOLLOWING PIGTAIL CONTRAST THROUGH A WET TO WET CONNECTION. THE PATIENT DID NOT HAVE ANY SYMPTOMS AND REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Air Embolism

  MAUDE report 16619516 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Air/Gas in Device; Adverse Event Without Identified Device or Use Problem; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 18MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER STEERABLE DELIVERY SHEATH. AFTER THE SHEATH WAS IN THE LAA AND WHILE THE DEVICE WAS BEING DEPLOYED, ST ELEVATIONS WERE NOTED. THE ST ELEVATIONS PERSISTED FOR 4 MINUTES AND RESOLVED WITHOUT INTERVENTION. THE PATIENT WAS REPORTED AS STABLE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED THAT AFTER THE TRANSEPTAL PUNCTURE WAS PERFORMED, THE STEERABLE DELIVERY SHEATH WAS EXCHANGED FOR THE TRANSEPTAL SHEATH. A CONTINUOUS FLUSH WAS ADMINISTERED THROUGH THE SIDE PORT OF THE DELIVERY SHEATH. THE DEVICE WAS PREPARED AND ATTACHED TO THE DELIVERY SHEATH VIA A WET-TO-WET CONNECTION. ST ELEVATIONS WERE NOTED WHEN THE DEVICE WAS BEING LOADED INTO THE DELIVERY SHEATH. THE DEVICE WAS DEPLOYED AND WAS BEING POSITIONED WHEN THE ST ELEVATIONS RESOLVED WITHOUT INTERVENTION. THE AMULET DEVICE WAS THEN SUCCESSFULLY POSITIONED AND RELEASED FROM THE DELIVERY CABLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS CLOSELY MONITORED.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 16546543 ↗
• InjuryMar 2, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER STEERABLE DELIVERY SHEATH. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA FOR THE DURATION OF THE PROCEDURE. AFTER THE STEERABLE SHEATH WAS IN POSITION IN THE LEFT ATRIUM AND THE PIGTAIL CATHETER WAS IN THE LEFT ATRIAL APPENDAGE, BUT BEFORE THE DEVICE WAS INSERTED, A ST SEGMENT ELEVATION WAS OBSERVED. AIR WAS VISUALIZED IN THE PATIENT VIA ECHOCARDIOGRAPHY IMAGES OF THE ANTERIOR LEFT VENTRICLE. THE EJECTION FRACTION WAS NOTICED TO BE DECREASED. CATHETERIZATION OF THE LEFT HEART WAS COMPLETED. AFTER 3-4 MINUTES THE ST SEGMENT RETURNED TO BASELINE AND WAS RESOLVED AFTER 8 MINUTES. THE AIR EMBOLISM RESOLVED, AND EJECTION FRACTION ALSO RETURNED TO BASELINE AFTER 8 MINUTES. THE AMULET DEVICE WAS SUCCESSFULLY IMPLANTED AFTER THE CATHETERIZATION AND THE ST ELEVATIONS WERE RESOLVED. THERE WAS A DELAY IN THE PROCEDURE, HOWEVER NO SERIOUS INJURY OCCURRED. THE PATIENT WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 16470184 ↗
• MalfunctionMar 1, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN DEVICE WAS CHOSEN FOR IMPLANT WITH AN AMPLATZER STEERABLE DELIVERY SHEATH. IT WAS REPORTED THE PATIENT EXHIBITED MINOR ST ELEVATIONS DUE TO AIR THAT RESOLVED WITHOUT INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 16463878 ↗
• MalfunctionMar 1, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN DEVICE WAS CHOSEN FOR IMPLANT WITH AN AMPLATZER STEERABLE DELIVERY SHEATH. IT WAS REPORTED THE PATIENT EXHIBITED MINOR ST ELEVATIONS DUE TO AIR THAT RESOLVED WITHOUT INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 16463839 ↗
• MalfunctionMar 1, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN DEVICE WAS CHOSEN FOR IMPLANT WITH AN AMPLATZER STEERABLE DELIVERY SHEATH. IT WAS REPORTED THE PATIENT EXHIBITED MINOR ST ELEVATIONS DUE TO AIR THAT RESOLVED WITHOUT INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 16463838 ↗
• MalfunctionMar 1, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN DEVICE WAS CHOSEN FOR IMPLANT WITH AN AMPLATZER STEERABLE DELIVERY SHEATH. IT WAS REPORTED THE PATIENT EXHIBITED MINOR ST ELEVATIONS DUE TO AIR THAT RESOLVED WITHOUT INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 16463815 ↗
• MalfunctionMar 1, 2023Air/Gas in Device; Air/Gas in Device

  THIS IS BEING FILED AS A PHYSICIAN REPORTED THAT THERE WERE ABOUT 6 PATIENTS WHO HAD ST ELEVATION THAT RESOLVED WITHIN A FEW MINUTES AND NO INTERVENTIONS. IT WAS SUSPECTED THAT THE ST ELEVATION WAS DUE TO AIR BUT WAS NOT CONFIRMED AS THERE WAS NO CONFIRMATION OF AIR VISUALIZED IN THE PATIENT OR THE DELIVERY SYSTEM.  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN DEVICE WAS CHOSEN FOR IMPLANT WITH AN AMPLATZER STEERABLE DELIVERY SHEATH. IT WAS REPORTED THE PATIENT EXHIBITED MINOR ST ELEVATIONS THAT RESOLVED QUICKLY WITHOUT INTERVENTION. AIR WAS ABLE TO BE VISUALIZED ON FLUOROSCOPY IMAGING. IT WAS NOTED THAT THERE WERE NO MAJOR ADVERSE PATIENT EFFECTS.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 16463784 ↗
• MalfunctionMar 1, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN DEVICE WAS CHOSEN FOR IMPLANT WITH AN AMPLATZER STEERABLE DELIVERY SHEATH. IT WAS REPORTED THE PATIENT EXHIBITED MINOR ST ELEVATIONS DUE TO AIR THAT RESOLVED WITHOUT INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 16463688 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 28MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING AN AMPLATZER STEERABLE DELIVERY SHEATH. AFTER THE DEFECT WAS SIZED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), THE PHYSICIAN PLANNED TO USE EITHER A 25MM OR 28MM AMULET DEVICE. A NON-ABBOTT GUIDEWIRE WAS INTRODUCED, AND THE STEERABLE SHEATH WAS TRACKED OVER THE GUIDEWIRE. THE DILATOR WAS THEN REMOVED FROM THE SHEATH, A PIGTAIL CATHETER WAS ADVANCED OVER THE GUIDEWIRE, AND THE GUIDEWIRE WAS REMOVED. AT THIS TIME CONTRAST WAS INJECTED INTO THE APPENDAGE AND THE PATIENT'S BLOOD PRESSURE DROPPED. THE PROCEDURE WAS PAUSED TO MONITOR THE PATIENT'S BLOOD PRESSURE. THE PATIENT'S BLOOD WAS RECYCLED THE PATIENT'S BLOOD PRESSURE RETURNED TO A SAFE READING. NO PERICARDIAL EFFUSION WAS NOTICED AT THIS TIME. THE PROCEDURE WAS CONTINUED. FLUOROSCOPY IMAGES WERE THEN TAKEN, AND THE PHYSICIAN DECIDED TO USE THE 28MM AMULET DEVICE. THE 28MM DEVICE WAS ADVANCED INTO THE APPENDAGE AND DEPLOYED. BEFORE THE DEVICE WAS RELEASED, THE PATIENT'S BLOOD PRESSURE DROPPED TO 68/38. THE PHYSICIAN OBSERVED VIA TEE THAT A LARGE PERICARDIAL EFFUSION OCCURRED IN THE PERICARDIAL SPACE. THE DEVICE WAS

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16381053 ↗
• InjuryFeb 14, 2023Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER STEERABLE DELIVERY SHEATH. THE DELIVERY SHEATH WAS PREPARED PER THE IFU AND A PRESSURE BAG OF HEPARIN SALINE WAS CONNECTED TO IT. BEFORE THE DEVICE WAS INSERTED INTO THE SHEATH, THE PIGTAIL CATHETER WAS BEING ADVANCED WHEN AIR WAS NOTED IN THE DEVICE. THEN, THE PATIENT HAD ST ELEVATIONS AND BRADYCARDIA. THE PATIENT WAS EXTUBATED. AFTER THE PATIENT STABILIZED, THE DEVICE WAS IMPLANTED SUCCESSFULLY USING A 12F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH IN A SEPARATE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE AND WAS DISCHARGED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia; Non specific EKG/ECG Changes

  MAUDE report 16376236 ↗
• MalfunctionJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER STEERABLE DELIVERY SHEATH. DURING THE PROCEDURE, THE PATIENT HAD ST ELEVATIONS THREE TIMES. THE ST ELEVATIONS RESOLVED WITHOUT TREATMENT AFTER 1-2 MINUTES EACH TIME. THERE WAS NO LEAK OR AIR EMBOLISM OBSERVED IN THE PATIENT. AN ANGIOGRAM WAS DONE TO CHECK CORONARY ARTERIES AND NOTHING ABNORMAL WAS NOTICED. THE DEVICE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED THAT ALL THREE OF THE ST ELEVATIONS OCCURRED WHEN THE STEERABLE SHEATH WAS IN PLACE AND THE PIG TAIL CATHETER WAS ADVANCED INTO LEFT ATRIUM. THE ST ELEVATIONS OCCURRED BEFORE THE AMULET WAS IMPLANTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 16106267 ↗
• InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN SIZED AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER STEERABLE DELIVERY SYSTEM. DURING THE PROCEDURE, A NON-ABBOTT PIG-TAIL CATHETER WAS BEING POSITIONED IN THE LEFT ATRIAL APPENDAGE (LAA) WITH THE STEERABLE SHEATH. THE PIG-TAIL CATHETER WAS DROPPED INTO THE LEFT VENTRICLE, RESULTING IN BRADYCARDIA FOLLOWED BY HYPOTENSION, ST ELEVATIONS, AND A MYOCARDIAL INFARCTION (STEMI). THE AMPLATZER STEERABLE SHEATH AND THE PIGTAIL CATHETER WERE REMOVED FROM THE LEFT ATRIUM. EPINEPHRINE WAS ADMINISTERED TO TREAT THE LOW BLOOD PRESSURE AND CARDIOPULMONARY RESUSCITATION (CPR) WAS CONDUCTED FOR ABOUT 2 MINUTES AND STOPPED ONCE THE PRESSURE HAD RETURNED TO NORMAL RANGES. ARTERIAL ACCESS WAS ATTAINED, AND THE CORONARY ARTERIES WERE ASSESSED. THERE WERE NO ABNORMALITIES NOTED IN THE CORONARY ARTERIES. ALL DEVICES AND SHEATHS WERE REMOVED, AND THE PATIENT WAS TRANSFERRED TO THE ICU FOR MONITORING. THE OCCLUDER WAS NOT IMPLANTED AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED AS STABLE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED THAT: IT WAS UNDETERMINED WHY THE P

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Myocardial Infarction

  MAUDE report 16045627 ↗
• InjuryDec 23, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2022, AN UNKNOWN DEVICE WAS SELECTED FOR IMPLANT USING AN UNKNOWN SIZED AMPLATZER STEERABLE SHEATH. DURING PROCEDURE, AIR EMBOLISM IN THE SHEATH WAS OBSERVED. THE AIR EMBOLISM WAS "VERY TINY AND HEALED ITSELF". NO INTERVENTION WAS REQUIRED AND NO ADVERSE EVENTS WERE REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Air Embolism

  MAUDE report 16043189 ↗
• InjuryDec 19, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 14F AMPLATZER STEERABLE DELIVERY SHEATH WAS SELECTED FOR PROCEDURE TO IMPLANT A 16 AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. IT WAS NOTED THAT THERE WAS A TOMBSTONE LIKE CHANGE ON THE INTRA-OPERATIVE ELECTROCARDIOGRAM DUE TO ST ELEVATION, BUT NO MYOCARDIAL INFARCTION WAS REPORTED. ALL THE SEQUENCES OF EVENTS FOR THE PROCEDURE HAD BEEN PERFORMED ACCORDING THE THE INSTRUCTIONS FOR USE. PATIENT WAS HEMODYNAMICALLY STABLE UP UNTIL THE ST ELEVATION NOTED. IT WAS ALSO NOTED THAT THE PATIENT'S BLOOD PRESSURE BECAME UNSTABLE. THE PATIENT'S BLOOD PRESSURE DROPPED TO 59/29, RESULTING IN BRADYCARDIA. THE PATIENT WAS ADMINISTERED EPINEPHRINE TO MITIGATE THEIR LOW BLOOD PRESSURE. A ECHOCARDIOGRAM WAS PERFORMED AND DISCOVERED AIR IN THE PATIENT'S LEFT ATRIUM AND LEFT VENTRICLE. ONLY ASPIRATION DONE WAS WHILE EVACUATING AIR OUT OF THE LEFT ATRIUM AND LEFT VENTRICLE. THE AIR WAS EVACUATED FROM THE PATIENT USING A 50CC SYRINGE CONNECTED TO THE BACK OF A 110CM PIGTAIL TO UNDER FLUOROSCOPIC AND TRANSESOPHAGEAL ECHOCARDIOGRAM GUIDANCE. IT WAS NOTED AFTER REMOVAL OF THE AIR FROM THE PATIENT THAT THE PATIENT'S HEART RATE INCREASED, BUT LEFT VENTRICULAR FUNCT

  Patient problems: Air Embolism; Bradycardia; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 16010205 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 14F AMPLATZER STEERABLE DELIVERY SHEATH WAS CHOSEN FOR PROCEDURE. A CONTINUOUS FLUSH WAS ATTACHED TO THE SIDE PORT. IMMEDIATELY AFTER THE DELIVERY SHEATH WAS INTRODUCED INTO THE PATIENT, THE PATIENT EXPERIENCED ST ELEVATIONS. AIR WAS SUSPECTED TO BE INTRODUCED DURING DELIVERY SHEATH INSERTION AND AFTER THE GUIDEWIRE WAS REMOVED. NO AIR EMBOLUS WAS OBSERVED. THE PATIENT'S BLOOD PRESSURE DECLINED. THE PHYSICIAN ADMINISTERED EPINEPHRINE WHICH RESOLVED THE PATIENT'S RHYTHM AND BLOOD PRESSURE. THE CASE WAS CONCLUDED WITHOUT IMPLANTING THE OCCLUDER. THERE WERE NO OTHER ADVERSE EFFECTS REPORTED. THE PATIENT WAS REPORTED AS STABLE AND RECOVERED WELL.

  Patient problems: Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 15890190 ↗
• InjuryNov 30, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2022, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER DEVICE WAS CHOSEN FOR IMPLANT USING A 14F AMPLATZER TORQVUE DELIVERY SYSTEM (8542872). THE PATIENT WAS UNDER GENERAL ANESTHESIA DURING THE PROCEDURE. AFTER INSERTING THE DELIVERY SYSTEM INTO THE PATIENT, IT WAS DETERMINED THAT THE TORQVUE SYSTEM COULD NOT GET COAXIAL ENOUGH FOR PROPER DEVICE DEPLOYMENT. THEN, A 14F AMPLATZER STEERABLE DELIVERY SHEATH (8426711) WAS CHOSEN FOR THE PROCEDURE. A CONTINUOUS FLUSH WAS ATTACHED TO THE SIDE PORT. THE STEERABLE SHEATH WAS INITIALLY INSERTED INTO THE PATIENT, BUT IT WAS DETERMINED THAT THE TRANSSEPTAL PUNCTURE WAS NOT ADEQUATE. THE SHEATH WAS REMOVED, AND A SECOND TRANSSEPTAL PUNCTURE WAS PERFORMED. A SECOND 14F AMPLATZER STEERABLE DELIVERY SHEATH (8426711) WAS INSERTED, AND THE AMULET DEVICE WAS DEPLOYED AND RECAPTURED AT LEAST TWICE WHEN THE PATIENT'S BLOOD PRESSURE DROPPED. THE PATIENT'S OXYGEN SATURATION ALSO DROPPED. NO EFFUSION WAS OBSERVED. IT WAS SUSPECTED THAT THE DELIVERY SHEATH CAUSED AN AIR EMBOLISM, BUT NO AIR WAS VISUALIZED IN THE PATIENT. THE AMULET DEVICE WAS NOT ABLE TO BE PLACED DUE TO PATIENT CONDITION AT THE TIME. THE PATIENT'S BLO

  Patient problems: Hypoxia; Low Blood Pressure/ Hypotension

  MAUDE report 15890187 ↗
• InjuryNov 22, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2022, AN AMPLATZER STEERABLE DELIVERY SHEATH WAS CHOSEN FOR USE. THE DILATOR AND SHEATH WAS FLUSHED USING THE EXTENSION TUBING. A STOPCOCK WAS USED TO ATTACH THE SALINE SYRINGE TO THE SHEATH. ONCE FLUSHED A PRESSURIZED SALINE BAG WAS ATTACHED TO THE EXTENSION TUBING OF THE SHEATH. THE SHEATH WAS ADVANCED OVER THE NON-ABBOTT (VERSACROSS) WIRE INTO THE LEFT ATRIUM. THE DILATOR WAS REMOVED AND HE PIGTAIL WAS ADVANCED OVER THE WIRE INTO THE LEFT ATRIUM. THE WIRE WAS REMOVED, AND THE LEFT ATRIAL APPENDAGE WAS ENGAGED WITH THE PIGTAIL. THE OPERATOR THEN INJECTED CONTRAST WITH A MANIFOLD. SHORTLY AFTER, SLIGHT ST ELEVATIONS WERE OBSERVED, AND IT WAS BELIEVED TO HAVE COME FROM THE BUBBLES. THE PROCEDURE WAS PAUSED FOR 5 MINUTES TO MONITOR THE ELECTROCARDIOGRAM. DURING THIS TIME THE ST ELEVATIONS DIMINISHED BACK TO NORMAL SINUS RHYTHM BY THE 5 MINUTE MARKER. NO MEDICATION OR INTERVENTION WAS REQUIRED. THERE NO CONCLUSIVE EVIDENCE ON WHAT CAUSED THE BUBBLES. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 15845866 ↗