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

Model Number	9-PDA-004
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	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that a 6-4mm amplatzer duct occluder was selected for implant on (b)(6) 2025 using a 6f amplatzer torqvue delivery system to treat a patent ductus arteriosus (pda).Both devices were prepared per ifu.During the procedure the occluder was partially re-captured once.When the occluder was placed on the pda the occluder took on an extended shape.The occluder was not released from the delivery cable.There were no interactions with cardiac structures.There were no angulations or kinks noted on the delivery system.Both the occluder and delivery system were removed from the patient and replaced with a new 8-6mm amplatzer duct occluder and 6f amplatzer torqvue delivery system.The user believed the occluder deformation may have been related to the connection to the delivery cable.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity during procedure was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Two photos were provided which appeared to show bulbous deformation on distal disc when deployed through the loader on the operation table.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.However, the cause of the reported device deformity could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 21709724
• Report Number: 2135147-2025-01587
• Device Sequence Number: 15970390
• Product Code: MAE
• UDI-Device Identifier: 00811806011110
• UDI-Public: (01)00811806011110(17)280930(10)10020133
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/12/2025

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 Model Number: 9-PDA-004
• Device Catalogue Number: 9-PDA-004
• Device Lot Number: 10020133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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[9-ITV06F180/80, LOT#10530405]
• Patient Age: 3 MO
• Patient Sex: Male
• Patient Weight: 5 KG