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

Catalog Number	9-ACP2-007-016
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pericardial Effusion (3271); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_1056 - advance laa, patient site id: (b)(6) it was reported that on (b)(6) 2024, a 16mm amplatzer amulet left atrial appendage occluder was chosen for implanting using a 14f amplatzer torqvue 45x45 delivery sheath.The device was sized using 2d transesophageal echocardiography (tee) and angiography.The landing zone was measured as 13-14mm.The appendage shape was chicken wing.Heparin was administered, and the activated clotting time (act) during the procedure was 325 seconds.Tee and fluoroscopy were used to guide the procedure.The amulet occluder had 0 partial recaptures and 0 full recaptures, and the device was implanted successfully.Protamine was administered to reverse the heparin.There were no reported adverse events during procedure.On (b)(6) 2024, a trivial pericardial effusion was seen on 2d transthoracic echocardiography (tte).No treatment was required.The patient status was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that the baseline echo had a prominent fat pad that was mistakenly read as a pericardial effusion.There were no reported adverse events during procedure.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 health effect - clinical code: code 3271 removed.H6 health effect - impact code: code 4613 removed.H6 medical device problem code: code 2993 removed.
Event or Problem Description
Clinical information: (b)(6) - advance laa, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 16mm amplatzer amulet left atrial appendage occluder was chosen for implanting using a 14f amplatzer torqvue 45x45 delivery sheath.The device was sized using 2d transesophageal echocardiography (tee) and angiography.The landing zone was measured as 13-14mm.The appendage shape was chicken wing.Heparin was administered, and the activated clotting time (act) during the procedure was 325 seconds.Tee and fluoroscopy were used to guide the procedure.The amulet occluder had 0 partial recaptures and 0 full recaptures, and the device was implanted successfully.Protamine was administered to reverse the heparin.There were no reported adverse events during procedure.On (b)(6) 2024, a trivial pericardial effusion was seen on 2d transthoracic echocardiography (tte).No treatment was required.The patient status was reported as stable.No additional information was provided.Subsequent to the previously filed report, additional information was received that upon review of transesophageal echocardiogram (tee) with the implanting physician, there was no report of a pericardial effusion during the procedure on tee on (b)(6) 2024.On (b)(6) 2024, a follow up transthoracic echocardiogram (tte) reports a prominent pericardial fat pad is present.A trivial, free-flowing pericardial effusion is identified anterior to the heart.The physician compared imaging from (b)(6) 2024 to imaging from (b)(6) 2013, and they reportedly looked identical.The physician reports that there was no pericardial effusion.The baseline echo had a prominent fat pad that as mistakenly read as a pericardial effusion.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18739784
• Report Number: 2135147-2024-00747
• Device Sequence Number: 15264756
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: 00811806013459
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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-ACP2-007-016
• Device Lot Number: 8776110
• 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: 01/26/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White