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	Arrhythmia (1721); Atrial Fibrillation (1729)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: crd_961 - pfo japan pas, patient site id: (b)(4).It was reported that on (b)(6) 2021, a 25mm amplatzer patent foramen ovale (pfo) occluder was successfully implanted in a patient.On (b)(6) 2021, the patient was discharged with a prescription for aspirin and p2y12 inhibitors.On (b)(6) 2021, the patient was hospitalized and diagnosed with an arrhythmia.An electrocardiogram at an outpatient clinic had showed that the patient was in sinus rhythm.Therefore, a holter electrocardiogram was performed on (b)(6) 2024, and confirmed that the patient was in atrial fibrillation.On (b)(6) 2021, the patient was started on direct oral anticoagulants to prevent further symptoms due to atrial fibrillation.The cause of the patient's atrial fibrillation was unable to be determined.
Additional Manufacturer Narrative
An event of atrial fibrillation and arrhythmia 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 event could not be determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 19226255
• Report Number: 2135147-2024-01941
• Device Sequence Number: 18057021
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: (01)00811806011288(17)250430(10)7533858
• 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
• Report Date (Section B): 05/01/2024

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: 04/30/2025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7533858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2020
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 86 KG