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

Model Number PFO OCCLUDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Clinical information: (b)(4).It was reported that on (b)(6)2021, a 25mm amplatzer pfo occluder was implanted.There were no issues noted post-operatively, and the patient was discharged from the hospital on (b)(6) 2021.On (b)(6) 2021, patient was prescribed p2y12 inhibitor (antiplatelet) and direct-acting oral anticoagulant (doac).On (b)(6) 2022, patient was only prescribed doac.On (b)(6)2022, the patient presented to the emergency room with loss of vision and was admitted.On brain magnetic resonance imaging (mri), there was no visualized infarct noted.The patient's symptoms resolved in ten hours.The patient was prescribed apixaban, a novel oral anticoagulant (noac).On (b)(6)2022, the patient was discharged from the hospital without sequelae.On (b)(6) 2023, a 2 year follow-up appointment was conducted, and no issues were confirmed.The patient was continuously being prescribed doac.There were no issues reported with the implanted amplatzer occluder.The physician did not believe that the transient ischemic attack (tia) was related to the amplatzer occluder.Patient has a significant past medical history of a cerebral infarction on (b)(6) 2020.The patient status was reported as stable.

Manufacturer Narrative

An event of transient ischemic attack (tia) was reported.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.Based on the information received, the cause of the reported incident could not be conclusively determined but could have been related to the patient's medical history.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: 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: 17080631
• MDR Text Key: 316795763
• Report Number: 2135147-2023-02488
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7622143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 69 KG