AMPLATZER AMULET
Report
- Report Number
- 2135147-2026-00940
- Event Type
- Death
- Date Received
- February 16, 2026
- Date of Event
- March 1, 2019
- Report Date
- February 26, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NGV
- PMA / PMN Number
- P200049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE ATTACHMENT: PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH CARDIOEMBOLIC STROKE DESPITE ORAL ANTICOAGULANT THERAPY: A MULTICENTER COHORT STUDY B2: DEATH DATE WAS ESTIMATED. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER AMULET DEVICE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ATRIAL FIBRILLATION, HYPERTENSION, DIABETES, CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, CHRONIC KIDNEY DISEASE, AND THROMBUS. COMPLICATIONS REPORTED INCLUDED DEATH, CARDIAC TAMPONADE, STROKE, PERICARDIAL EFFUSION; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. THE REPORTED IFU DEVIATION/OFF-LABEL USE WAS ASSOCIATED WITH IMPLANTING THE AMPLATZER AMULET DEVICE IN PATIENTS WITH PRE-EXISTING THROMBUS. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. LITERATURE ATTACHMENT: PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH CARDIOEMBOLIC STROKE DESPITE ORAL ANTICOAGULANT THERAPY: A MULTICENTER COHORT STUDY. B2: DEATH DATE WAS ESTIMATED. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
THE ARTICLE, "PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH CARDIOEMBOLIC STROKE DESPITE ORAL ANTICOAGULANT THERAPY: A MULTICENTER COHORT STUDY", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE SAFETY AND EFFICACY OF THE HYBRID STRATEGY LEFT ATRIAL APPENDAGE OCCLUDER CLOSURE (LAAC) AND CONTINUED ORAL ANTICOAGULANT (OAC) WITH THE CURRENT STANDARD OF CARE IN PATIENTS WITH CARDIOEMBOLIC STROKE (CS) DESPITE ADEQUATE OAC. THE DEVICES INCLUDED IN THIS STUDY WERE WATCHMAN, AMPLATZER AMULET, AND LAMBRE. THE ARTICLE CONCLUDED THAT THE COMBINED STRATEGY OF LAAC AND CONTINUED ANTICOAGULATION REPORTED BETTER LONG-TERM OUTCOMES TO CONTROLS TREATED WITH OAC ALONE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ALBERTO PREDA, DE GASPERIS CARDIO CENTER, ELECTROPHYSIOLOGY UNIT, NIGUARDA HOSPITAL, MILAN, ITALY, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WITH CS WHO UNDERWENT LAAC OR MEDICAL THERAPY FROM 01 MARCH 2019 TO 31 MARCH 2023. A TOTAL OF 109 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 44 FORMED THE LAAC GROUP. OF THE 44 PATIENTS IN THE LAAC GROUP, 50% (22) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE OF THE LEFT ATRIAL APPENDAGE CLOSURE (LAAC) GROUP WAS 71 YEARS. THE AVERAGE AGE OF THE MEDICAL THERAPY GROUP WAS 73 YEARS. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ATRIAL FIBRILLATION, HYPERTENSION, DIABETES, CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, CHRONIC KIDNEY DISEASE, AND THROMBUS.
THE ARTICLE, "PERCUTANEOUS LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH CARDIOEMBOLIC STROKE DESPITE ORAL ANTICOAGULANT THERAPY: A MULTICENTER COHORT STUDY", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE SAFETY AND EFFICACY OF THE HYBRID STRATEGY LEFT ATRIAL APPENDAGE OCCLUDER CLOSURE (LAAC) AND CONTINUED ORAL ANTICOAGULANT (OAC) WITH THE CURRENT STANDARD OF CARE IN PATIENTS WITH CARDIOEMBOLIC STROKE (CS) DESPITE ADEQUATE OAC. THE DEVICES INCLUDED IN THIS STUDY WERE WATCHMAN, AMPLATZER AMULET, AND LAMBRE. THE ARTICLE CONCLUDED THAT THE COMBINED STRATEGY OF LAAC AND CONTINUED ANTICOAGULATION REPORTED BETTER LONG-TERM OUTCOMES TO CONTROLS TREATED WITH OAC ALONE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ALBERTO PREDA, DE GASPERIS CARDIO CENTER, ELECTROPHYSIOLOGY UNIT, NIGUARDA HOSPITAL, MILAN, ITALY, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WITH CS WHO UNDERWENT LAAC OR MEDICAL THERAPY FROM 01 MARCH 2019 TO 31 MARCH 2023. A TOTAL OF 109 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 44 FORMED THE LAAC GROUP. OF THE 44 PATIENTS IN THE LAAC GROUP, 50% (22) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE OF THE LEFT ATRIAL APPENDAGE CLOSURE (LAAC) GROUP WAS 71 YEARS. THE AVERAGE AGE OF THE MEDICAL THERAPY GROUP WAS 73 YEARS. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ATRIAL FIBRILLATION, HYPERTENSION, DIABETES, CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, CHRONIC KIDNEY DISEASE, AND THROMBUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 188069 | AMPLATZER AMULET | CARDIAC PLUG | NGV | ABBOTT MEDICAL | UNK AMPLATZER AMULET |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |