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

Model Number	9-PFO-025
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.B3 - date of event is an estimated date.
Event or Problem Description
It was reported that on (b)(6) 2020, a 25mm amplatzer patent foramen ovale (pfo) occluder (lot: 6551982) was implanted.Since approximately four weeks post-operation, the patient experienced full body hives whenever exerting any kind of energy and does not sweat anymore.In addition, the patient feels inflamed all the time with puffy eyes.An allergic reaction to the amplatzer pfo occluder is suspected by the patient.
Event or Problem Description
It was reported that on (b)(6) 2020, a 25 mm amplatzer patent foramen ovale (pfo) occluder (lot: 6551982) was implanted.Since approximately four weeks post-operation, the patient experienced full body hives whenever exerting any kind of energy and does not sweat anymore.In addition, the patient feels inflamed all the time with puffy eyes.An allergic reaction to the amplatzer pfo occluder is suspected by the patient.In the physician's opinion the issue could be related to the device as the patient tested positive for nickel in their blood.No intervention was reported.
Additional Manufacturer Narrative
It was reported that approximately four weeks post-operation, the patient experienced full body hives whenever exerting any kind of energy and does not sweat anymore.In addition, the patient feels inflamed all the time with puffy eyes.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from field indicated that there were no malfunctions or issues with device during the implant procedure or post-implant follow-up and no relevant intraprocedural patient issues at the time of implant.It is difficult to determine the exact cause for these symptoms.Based on information available and medical review performed at abbott, it is unlikely that the symptoms are caused by the amplatzer pfo occluder.An allergic reaction following a pfo implant typically occurs soon after implant within a few days rather than 4 weeks later.No intervention was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes added: h6 medical device problem code: 4001 patient device interaction problem.

• 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: 21873837
• Report Number: 2135147-2025-02090
• Device Sequence Number: 8768549
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: (01)00811806011288(17)230630(10)6551982
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/29/2025

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: 06/30/2023
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 6551982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2018
• 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 Sex: Male