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

Model Number	9-PFO-025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	10/04/2025
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: crd_806 - pfo occluder pas, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 25mm amplatzer pfo occluder was chosen for implant using a unknown size amplatzer trevisio intravascular delivery system.During procedure, a 5000 units of heparin was given and the occluder was successfully implanted.On (b)(6) 2025, the patient presented with left arm weakness and left arm went limp.The patient also had a bloody nose and it got resolved.The symptoms lasted less than one minute and got resolved.Some medications were administered.The patient was reported discharged.
Event or Problem Description
Clinical information: (b)(6) - pfo occluder pas, patient site id: (b)(6) (b)(4).It was reported that on (b)(6) 2025, a 25mm amplatzer pfo occluder was chosen for implant using an unknown size amplatzer trevisio intravascular delivery system.During procedure, a 5000 units of heparin was given and the occluder was successfully implanted.On (b)(6) 2025, the patient presented with left arm weakness and left arm went limp.The patient also had a bloody nose and it got resolved.The symptoms lasted less than one minute and got resolved.Some medications were administered.The patient was reported discharged.On (b)(6) 2025, a loop recorder was placed.
Additional Manufacturer Narrative
An event health related of movement disorder was reported.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, a cause for the reported movement disorder could be related to insufficient blood flow, however this could not be confirmed.An unexpected medical intervention was performed as the patient was administered medicine to treat the movement event.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 23441571
• Report Number: 2135147-2025-06298
• Device Sequence Number: 14626526
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: (01)00811806011288(17)251130(10)7771401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 11/30/2025
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7771401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2020
• 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: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White