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

Catalog Number	9-ACP2-007-016
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); 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	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
(b)(4).It was reported that on (b)(6) 2024, an 16 mm amplatzer amulet left atrial appendage (laa) occluder (lot: 8880820) was chosen for implantation utilizing a 12f amplatzer torqvue delivery system.The device was implanted successfully with one full recapture.Post procedure the same day, trace pericardial effusion was observed.Patient was asymptomatic.Unspecified treatment was performed.The effusion resolved on (b)(6) 2024.
Additional Manufacturer Narrative
An event of no apparent adverse event and improper or incorrect procedure or method was reported.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.Based on the information received, the reported improper or incorrect procedure or method appears to be related to user fully recaptured the device.The reported no apparent adverse event as there was not adverse event to the patient.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 - adverse event problem - health effect - clinical code: 3271 removed, health effect - impact code: 4641 removed, medical device problem code: 2993 removed.
Event or Problem Description
Crd_1056 (b)(6).It was reported that on (b)(6) 2024, an 16 mm amplatzer amulet left atrial appendage (laa) occluder (lot: 8880820) was chosen for implantation utilizing a 12f amplatzer torqvue delivery system.The device was implanted successfully with one full recapture.There were no patient effects or device issues.

• 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: 20339675
• Report Number: 2135147-2024-04808
• Device Sequence Number: 18142509
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)280131(10)8880820
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 8880820
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2023
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White