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	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, an 18mm amplatzer pfo was selected for implant using a non- abbott sheath/delivery system that was available.The left atrial disc would deploy and then there was difficulty in deploying the right atrial disc.It appeared bulbous in shape and after multiple deployments, the device was removed from the patient for inspection.The device was never released from the delivery cable while inside the patient and there was no angulation/kink observed with the delivery system.It was reported that there was interaction with cardiac structures during deployment.A 25mm amplatzer pfo was selected and successfully implanted as a replacement.The patient was reported to have been discharged home.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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 defined manufacturing specifications.Information from field indicated that an 8f delivery sheath was used and there was no angulation or kink in the delivery system.Based on the information received, the reported device deformity appears to be related to procedural circumstance as it was reported that there was an interaction with cardiac structure during deployment.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 16448774
• Report Number: 2135147-2023-00714
• Device Sequence Number: 5875879
• Product Code: MLV
• UDI-Device Identifier: 00811806011271
• UDI-Public: 00811806011271
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/11/2023

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: 01/31/2026
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-018
• Device Lot Number: 7860355
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• 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