MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PATENT FORAMEN OVALE (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 Code	Stroke/CVA (1770)
Date of Event	08/30/2023
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
Clinical information: (b)(4) - pfo japan pas, patient site id: (b)(6).It was reported that on (b)(6) 2021, a 25mm amplatzer patent foramen ovale (pfo) occluder was successfully implanted in a patient.The patient was prescribed p2y12 inhibitor and dual oral anticoagulation medication after procedure.On (b)(6) 2023, it was noted that the patient suffered a hemorrhagic stroke.The patient's symptoms lasted less than 24 hours.There was no treatment required.However, the patient was hospitalized and discharged on (b)(6) 2023.It was noted during the patient's 3 year follow up that there was no significant residual shunt or thrombus seen attached to the disc of the 25mm amplatzer (pfo) occluder.The occluder remains implanted and no anomaly of the occluder has been reported.
Event or Problem Description
Clinical information: crd_961 - pfo japan pas, patient site id: (b)(6) (r845396001).It was reported that on (b)(6) 2021, a 25mm amplatzer patent foramen ovale (pfo) occluder was successfully implanted in a patient.The patient was prescribed p2y12 inhibitor and dual oral anticoagulation medication after procedure.On 30 august 2023, it was noted that the patient suffered a hemorrhagic stroke.The patient's symptoms lasted less than 24 hours.There was no treatment required.However, the patient was hospitalized and discharged on (b)(6) 2023.It was noted during the patient's 3 year follow up that there was no significant residual shunt or thrombus seen attached to the disc of the 25mm amplatzer (pfo) occluder.The occluder remains implanted and no anomaly of the occluder has been reported.
Additional Manufacturer Narrative
An event of hemorrhagic stroke 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's symptoms lasted less than 24 hours.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 PATENT FORAMEN OVALE (PFO) OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19570608
• Report Number: 2135147-2024-02902
• Device Sequence Number: 6948292
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: (01)00811806011288(17)250930(10)7689298
• 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): 07/24/2024

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: 09/30/2025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7689298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2020
• 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: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 43 KG