MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Model Number	9-ACP2-010-034
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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, however the occluder embolized in the left atrium.The patient was transferred to cardiac surgery for surgical removal of the occluder and closure of the laa.Per the physician, the puncture and subsequent pericardial effusion and cardiac tamponade may have been due to the first attempt at transseptal puncture that was too posterior.The patient status was stable.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that after release of the amulet occluder from the delivery cable a pericardial effusion was visualized on transthoracic echocardiogram (tte) that led to cardiac tamponade.The patient's blood pressure decreased slowly and was low.A pericardiocentesis was performed and the patient became hemodynamically stable; two hours post-procedure on tte there was no pericardial effusion, however the occluder embolized in the left atrium.The cine review confirmed the reported pericardial effusion.Information from field indicated that the occluder was partially recaptured three times and there was difficulty implanting the amulet occluder which may have contributed to the observed pericardial effusion and device embolization, however this cannot be conclusively determined.A returned device assessment could not be performed as the device 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.The exact cause of device embolization could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the patient was transferred to cardiac surgery for surgical removal of the occluder and closure of the laa.The reported patient effect of hypotension appears to be procedure-related.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.

• Brand Name: AMPLATZER AMULET
• Common Device Name: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21816151
• Report Number: 2135147-2025-01873
• Device Sequence Number: 7350975
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)250831(10)7662817
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 9-ACP2-010-034
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 7662817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown