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

Catalog Number	9-ACP2-010-034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pericardial Effusion (3271)
Date of Event	09/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
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.Heparin was administered with the patient's activated clotting time (act) levels 291 seconds.Prior to the procedure, the patient had a trivial effusion, patient was implanted with 34mm amplatzer amulet left atrial appendage occluder with 0 recaptures, device placement and closure were confirmed by transesophageal echocardiogram, patient was sent home at 3pm, patient returned to the hospital at 9pm with a pulmonary embolism and a worsened pericardial effusion noted circumferential.Pericardiocentesis was performed successfully removing 500cc of fluid, drain was placed, patient went home a week later in stable condition.No additional information was provided.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
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 unknown.The cause of the pulmonary embolism was unknown but possibly due to protamine.
Additional Manufacturer Narrative
It was reported that the patient returned to hospital the same day of amulet device implant with pulmonary embolism and a worsened circumferential pericardial effusion.Information from field indicated that amulet occluder was implanted with no recaptures, and the device placement and closure were confirmed by transesophageal echocardiogram.The patient's activated clotting time was 291s (in therapeutic range) and heparin was administered.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.The cause of reported patient effects pericardial effusion and pulmonary embolism could not be conclusively determined.The reported intervention was a result of case-specific circumstances as a pericardiocentesis was performed successfully removing 500cc of fluid and drain was placed.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: 20398531
• Report Number: 2135147-2024-04942
• Device Sequence Number: 6517561
• Product Code: NGV
• UDI-Device Identifier: 00811806013527
• UDI-Public: (01)00811806013527(17)280131(10)8916325
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ACP2-010-034
• Device Lot Number: 8916325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2023
• 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