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

Model Number	9-PFO-3525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hypoxia (1918); Respiratory Insufficiency (4462)
Date of Event	11/17/2022
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
It was reported that on 17 november 2022, a 35-25mm amplatzer talisman pfo occluder was chosen for implant using a 9f amplatzer trevisio intravascular delivery system.The occluder was chosen to close a large patent foramen ovale (pfo) with bidirectional shunting that was observed on transesophageol echocardiogram (tee).Prior to procedure from 30 october 2022 to 7 november 2022, the patient was admitted to the hospital for shortness of breath and hypoxia due to large pfo.During procedure for implant of pfo occluder, 8000 units iv heparin were administered, and the patient was under conscious sedation.During deployment and implantation of the pfo occluder, the patient became minimally responsive and hypoxic.The sedation was reversed, and oxygen saturation improved.However, the patient was still minimally responsive, so the patient was intubated.A coronary angiogram was performed, which was negative for acute occlusions of the coronary arteries.The patient was transported to computerized tomography (ct) scan with the stroke neurology team.The patient was diagnosed with acute hypoxic respiratory failure and altered level of consciousness with unclear etiology.The patient status was unknown.
Additional Manufacturer Narrative
An event of hypoxia, respiratory insufficiency and stroke 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.Information from the field indicated that there was no difficulty implanting the device.Information from the field also indicated that the physician believes the patient became hypoxic do to the pfo being open.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
N/a.

• Brand Name: AMPLATZER TALISMAN 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: 15974581
• Report Number: 2135147-2022-02525
• Device Sequence Number: 6960287
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: 05415067033345
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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: 01/31/2025
• Device Model Number: 9-PFO-3525
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 8328670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV09F45/80
• Outcome Attributed to Adverse Event: Other; Life Threatening; Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female