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

Catalog Number	9-PFO-025
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	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 25mm amplatzer pfo occluder was selected for implant on (b)(6) 2024 using a 9f amplatzer trevisio intravascular delivery system.During implant the left atrial disc of the device took on a bulbous shape.Several attempts were made to re-load the device and re-deploy, however the discs maintained a deformed shape.The device was not released from the delivery cable.The device was removed from the patient and replaced with a new 25mm amplatzer pfo occluder.There were some interactions with cardiac structures.There were no angulations noted on the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays during the procedure.There were no adverse effects to the patient.The patient status was stable.
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 was reported.The device was returned to abbott for investigation and 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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported device deformity could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instruction for use (ifu), artmt600161356 revision a, the recommended sheath size for amplatzer pfo occluder is 8f.

• 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: 20926318
• Report Number: 2135147-2024-06362
• Device Sequence Number: 5068611
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: (01)00811806011288(17)270930(10)8689363
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/18/2025

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 Catalogue Number: 9-PFO-025
• Device Lot Number: 8689363
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 9F AMPLATZER TREVISIO INTRA DS [9-ATV09F45/80]
• Patient Sex: Unknown