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	01/03/2023
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 patent foramen ovale (pfo) occluder was selected for implant using a 12f amplatzer trevisio intravascular delivery system.It was noted during procedure that the occluder exhibited a cobra deformation when being deployed.There were attempts to recapture and redeploy the occluder, but the deformation persisted.The decision was made to remove and replace the 35mm amplatzer (pfo) occluder with another one of the same size, but the replacement also exhibited a cobra deformation.The replacement 35mm amplatzer patent foramen ovale (pfo) occluder was then removed and replaced by a 25mm amplatzer patent foramen ovale (pfo) occluder to successfully complete the procedure.No patient consequences were reported.
Event or Problem Description
It was reported that on (b)(6) 2023, a 35mm amplatzer patent foramen ovale (pfo) occluder was selected for implant using a 12f amplatzer trevisio intravascular delivery system.It was noted during procedure that the occluder exhibited a cobra deformation when being deployed.There were attempts to recapture and redeploy the occluder, but the deformation persisted.The decision was made to remove and replace the 35mm amplatzer (pfo) occluder with another one of the same size, but the replacement also exhibited a cobra deformation.The replacement 35mm amplatzer patent foramen ovale (pfo) occluder was then removed and replaced by a 25mm amplatzer patent foramen ovale (pfo) occluder to successfully complete the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met 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 specifications.The cause of the reported incident could not be conclusively determined, however is consistent with use of larger sheath as use of larger sheath may influence deformations of the device.Please note that per the instructions for use, the recommended size delivery system for use with a 35 mm amplatzer pfo occluder is an 9f.

• 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: 16224697
• Report Number: 2135147-2023-00251
• Device Sequence Number: 17455404
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 03/21/2023

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 Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 8401340
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2022
• 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
• Patient Sex: Unknown