MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number	9-PFO-025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Movement Disorder (4412)
Date of Event	06/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_961 - pfo japan pas, patient site id:(b)(6).It was reported that a 25mm amplatzer pfo occluder was implanted on (b)(6) 2021.P2y12 inhibitor (antiplatelet) and direct oral anticoagulants (doac) were prescribed post-procedure.On (b)(6) 2023, during a 2-year patient follow-up no issues were detected and the patient was only prescribed antiplatelet.On (b)(6) 2023 the patient experienced an ischemic stroke and presented with paralysis in the upper and lower extremities and aphasia.The patient was rushed to the hospital and administered edaravone.The symptoms were reportedly resolved.It was believed that the stroke was unrelated to the device and procedure.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of ischemic stroke and paralysis in the upper and lower extremities and aphasia after two years of device implant was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.It was reported that the patient was hospitalized and medication was administered, the symptoms were reportedly resolved.Based on the information received, the cause of the reported incident could not be conclusively determined.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.

• Brand Name: AMPLATZER PFO OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19203843
• Report Number: 2135147-2024-01889
• Device Sequence Number: 20851167
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: (01)00811806011288(17)251130(10)7769239
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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 Expiration Date: 11/30/2025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7769239
• 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: 04/04/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2020
• 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: Disability; Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Unknown
• Patient Weight: 46 KG