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

Model Number	9-PFO-035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of atrial fibrillation when the device was positioned was reported.A more comprehensive 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.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Clinical study patient id: (b)(6).It was reported that on (b)(6) 2021, a 35 mm amplatzer pfo occluder was selected for implant.During the procedure, when the device was positioned, it was noticed that the patient was in atrial fibrillation with an heart rate around 130 bpm.The patient was treated with iv metoprolol and was then cardioverted to sinus rhythm.Bisoprolol was also prescribed and the patient will use a holter monitor.There was no delay in the procedure and the patient remained hemodynamically stable throughout.The patient is currently stable and has been discharged.
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
Clinical study patient id: (b)(6).Additional information received indicating that on (b)(6) 2021, the patient developed atrial fibrillation that required cardioversion, apixaban, and a hold in plavix.The patient will be monitored on their follow-ups.

• Brand Name: AMPLATZER 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; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13061266
• Report Number: 2135147-2021-00586
• Device Sequence Number: 1506236
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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: 06/30/2026
• Device Model Number: 9-PFO-035
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 8071699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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; Other
• Patient Age: 25 YR
• Patient Sex: Male