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 Code	Atrial Fibrillation (1729)
Date of Event	03/06/2024
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)(6) - pfo occluder pas, patient site id: (b)(6) it was reported that on (b)(6) 2022, 25mm amplatzer pfo occluder was chosen for implant using a 9f amplatzer trevisio intravascular delivery system.During procedure, a 6000 units of heparin was administered and the device was successfully implanted.After the procedure, a implantable loop recorder was connected to the patient.The loop recorder showed 3 separate episodes of 3 minute atrial fibrillation.The patient stopped taking aspirin and started 20mg rivaroxaban.They planned to reassess the loop recorder again in 6 months.The patient was reported stable.
Additional Manufacturer Narrative
An event of atrial fibrillation was reported.A returned device assessment 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.Reportedly, after the procedure, a implantable loop recorder was connected to the patient.The loop recorder showed 3 separate episodes of 3 minute atrial fibrillation.The patient stopped taking aspirin and started on rivaroxaban.The patient was reported stable.Based on the information received, the cause of the reported atrial fibrillation could not be conclusively determined.The reported hospitalization and unexpected medical intervention were a result of case-specific circumstances.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: 19949600
• Report Number: 2135147-2024-03875
• Device Sequence Number: 8967290
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: (01)00811806011288(17)261031(10)8211874
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/20/2024

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 Catalogue Number: 9-PFO-025
• Device Lot Number: 8211874
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian