AMPLATZER AMULET
Report
- Report Number
- 2135147-2025-04072
- Event Type
- Injury
- Date Received
- July 24, 2025
- Date of Event
- July 1, 2025
- Report Date
- August 26, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NGV
- UDI-DI
- 00811806013480
- PMA / PMN Number
- P200049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN EVENT OF PERICARDIAL EFFUSION FOLLOWING DAY OF AMULET PROCEDURE WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE LIMITED INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. THERE WERE NO COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES FROM THE LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.
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.
IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FIR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS 13MMHG AND HEPARIN WAS ADMINISTERED. THE AMULET WAS IMPLANTED AFTER ONE PARTIAL RECAPTURE. THE FOLLOWING DAY POST PROCEDURE, THE PATIENT HAD NOTED LOCALIZED EFFUSION AND BEING KEPT OVERNIGHT AGAIN TO ASSESS FLUID. THE PATIENT WAS REPORTED STABLE AND DISCHARGED.
IT WAS REPORTED THAT ON (B)(6) 2025, A 22MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS CHOSEN FIR IMPLANT USING A 14F AMPLATZER TORQVUE 45X45 DELIVERY SHEATH. DURING PROCEDURE, THE LEFT ATRIAL PRESSURE WAS 13MMHG AND HEPARIN WAS ADMINISTERED. THE AMULET WAS IMPLANTED AFTER ONE PARTIAL RECAPTURE. THE FOLLOWING DAY POST PROCEDURE, THE PATIENT HAD NOTED LOCALIZED EFFUSION AND BEING KEPT OVERNIGHT AGAIN TO ASSESS FLUID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1370869 | AMPLATZER AMULET | CARDIAC PLUG | NGV | ABBOTT MEDICAL | 9-ACP2-007-022 | 10714490 | 00811806013480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Hospitalization| O |