MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	9-PDA-005
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation.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 06 february 2025, a 8-6mm amplatzer duct occluder ii (lot: 10395115) was chosen for implantation into patent ductus arteriosus (pda) utilizing a 6f amplatzer torqvue delivery system (lot: 10482218).The device was placed in the pda, butthe placement was not in the usual state due to the shape of the pda so the device was removed and re-examined outside of the anatomy.Upon inspection, fiber-like material (possibly thrombus) was observed attached to the occluder along with threads.As a precaution, the occluder and delivery system were exchanged.No additional anticoagulant was given.The replacement 8-6mm amplatzer duct occluder ii was implanted successfully utilizing a 6f amplatzer torqvue delivery system.There were no adverse patient consequences.
Additional Manufacturer Narrative
An event of thrombus and potruding thread was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, a cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Per the information available abbott cannot further speculate on why the reported event occurred.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: 21547808
• Report Number: 2135147-2025-01159
• Device Sequence Number: 17925539
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: (01)00811806011127(17)290531(10)10395115
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-PDA-005
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 10395115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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: 6F AMPLATZER TORQVUE DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 12 KG