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

Model Number	9-PDA-005
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 8-6mm amplatzer pda occluder was chosen for implant using a 6f amplatzer torqvue delivery system.Initially, the physicians elected to attempt closure of the duct using a 12/8 vascular plug.During the procedure, the 12/8 vascular plug was determined to be oversized and therefore ineffective for the intended purpose.As a result, the team decided to remove the vascular plug and proceed with the use of a device specifically designed for patent ductus arteriosus closure.Following this decision, the amplatzer duct occluder (ado) was implanted via venous access, in accordance with the instructions for use.Device sizing and procedural guidance were performed using fluoroscopy, and the defect measured 2.2mm at the pulmonary end, 5.6mm aortic ampulla, with a total canal length of 21.3mm.A stability check was performed, with the team waiting 5 minutes prior to release, and no peridevice leak was detected at that time.Approximately five minutes after device release, embolization was identified on prosthesis fluoroscopy, with the device migrating toward the aorta.Due to the embolization, the patient was referred to cardiac surgery; the ado device was surgically removed and discarded.The implanter believes the embolization/migration occurred because the prosthesis was not suitable for the canal length and that a vascular plug would have been the more appropriate choice.It was reported that the issue was related to mis-sizing, although there were no allegations regarding the sizing of the device.The patient¿s current status is well and stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A event of device embolization 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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported device embolization could not be determined.A surgical intervention was a result of case specific circumstances, as the device was surgically removed.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 24537169
• Report Number: 2135147-2026-01452
• Device Sequence Number: 10343376
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: (01)00811806011127(17)291031(10)10605049
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 03/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PDA-005
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 10605049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 MO
• Patient Sex: Unknown