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

Catalog Number	9-ACP2-007-016
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
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 16mm amplatzer amulet left atrial appendage occluder was selected for an implant using 12f amplatzer torqvue 45x45 delivery sheath (tv45x45).During the procedure, when the when the disk was deployed it had a very contorted shape observed on echocardiogram and fluro.Device was removed from the patient prior to released from the cable.No angulation or kink noticed in the delivery system.The patient is stable, no additional information was provided.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device inspection 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.Information from the account indicated that there was no anatomical interference, there was no angulation or kink in the delivery system upon deployment, and an appropriately sized 12f delivery catheter was used.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18646718
• Report Number: 2135147-2024-00512
• Device Sequence Number: 20898967
• Product Code: NGV
• UDI-Device Identifier: 00811806013459
• UDI-Public: (01)00811806013459(17)270831(10)8664361
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P200049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 04/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ACP2-007-016
• Device Lot Number: 8664361
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Male