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

Model Number	PFO OCCLUDER
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 18mm amplatzer pfo occluder was selected for an implant on (b)(6) 2022.During deployment there was bulging right atrial disc, preventing correct apposition to the septum.There was no interaction with cardiac structures during deployment and no angulation or kink noticed in the delivery system.The occluder was exchanged for a new 18mm amplatzer pfo occluder, which was successfully implanted.The patient remained hemodynamically stable through the procedure and no clinical significant delay was reported.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met visual and functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.An image from field appeared to be taken during imaging and showed bulbously deformed proximal disc of occluder device while connected to the delivery cable.The cause of the reported incident could not be conclusively determined.

• 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: 15188707
• Report Number: 2135147-2022-00684
• Device Sequence Number: 5851309
• Product Code: MLV
• UDI-Device Identifier: 00811806011271
• UDI-Public: 00811806011271
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 09/13/2022

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: 09/30/2024
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-018
• Device Lot Number: 7219040
• 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: 07/13/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2019
• 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: Male