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

Model Number	PFO OCCLUDER
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
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 (b)(6) 2023, a 35mm amplatzer pfo occluder was selected for an implant.During the procedure there was slight weaves of thread coming off seen on the sides of the rims on the device.The physician felt that this was not comfortable for the patient and decided to change the device.Another 35mm amplatzer pfo occluder was opened and implanted successfully with no adverse effect.Patient stable.
Event or Problem Description
It was reported that on (b)(6) 2023, a 35mm amplatzer pfo occluder was selected for an implant.During the procedure there was slight weaves of thread coming off seen on the sides of the rims on the device.The physician felt that this was not comfortable for the patient and decided to change the device.Another 35mm amplatzer pfo occluder was opened and implanted successfully with no adverse effect.Patient stable.
Additional Manufacturer Narrative
The reported event of a protruding polyester thread was confirmed, a sewing knot was preset on the proximal disc of device.However this knot met dimensional specifications when analyzed at abbott.The sewing knots that are seen above the nitinol wires are considered a normal and acceptable characteristic of the occluder and are a result of the manufacturing process.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.
Additional Manufacturer Narrative
N/ad6b - explant date and d6a - implant date were updated - as the device issue was noted during preparation and not used in the patient.
Event or Problem Description
N/a.

• 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: 16632120
• Report Number: 2135147-2023-01381
• Device Sequence Number: 5576999
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 7946093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 05/15/2023; 06/02/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 06/01/2023; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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
• Patient Sex: Unknown