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

Model Number	9-PDA-004
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 6-4mm amplatzer pda was implanted using a 6f amplatzer torqvue delivery system to treat a ductus arteriosus defect measuring 4 mm at the aortic end and 2 mm at the pulmonary end, with device sizing determined based on these measurements and the conical anatomy of the ductus.The procedure was performed using angiographic imaging.A stability check was performed, and the physician reported no significant peri-device leak and no difficulty during implantation, including no need for multiple recaptures or repositioning.No rhythm changes were observed during the procedure.Approximately 1 hour and 20 minutes after device release, the physician reviewed a chest x-ray, which confirmed that the device had completely dislodged from the implant site and embolized to the right pulmonary artery.The implanter believed the embolization may have occurred because after release, the disc shifted into the ductus arteriosus, and later considered the patient was likely not well hydrated.The embolized device did not cause partial or complete obstruction of blood flow, and the patient remained hemodynamically stable.To address the embolization, the physician performed percutaneous retrieval via the groin using an 8f amplatzer torqvue delivery system to snare and successfully retrieve the device.The physician described the retrieval as an urgent intervention due to the device¿s position.The procedure was completed using a non-abbott device.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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.
Additional Manufacturer Narrative
An event of a 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 and cine review, the cause for the reported device embolization could not be determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2026, a 6-4mm amplatzer pda was implanted using a 6f amplatzer torqvue delivery system to treat a ductus arteriosus defect measuring 4 mm at the aortic end and 2 mm at the pulmonary end, with device sizing determined based on these measurements and the conical anatomy of the ductus.The procedure was performed using angiographic imaging.A stability check was performed, and the physician reported no significant peri-device leak and no difficulty during implantation, including no need for multiple recaptures or repositioning.No rhythm changes were observed during the procedure.Approximately 1 hour and 20 minutes after device release, the physician reviewed a chest x-ray, which confirmed that the device had completely dislodged from the implant site and embolized to the right pulmonary artery.The implanter believed the embolization may have occurred because after release, the disc shifted into the ductus arteriosus, and later considered the patient was likely not well hydrated.The embolized device did not cause partial or complete obstruction of blood flow, and the patient remained hemodynamically stable.To address the embolization, the physician performed percutaneous retrieval via the groin using an 8f amplatzer torqvue delivery system to snare and successfully retrieve the device.The physician described the retrieval as an urgent intervention due to the device¿s position.The procedure was completed using a non-abbott device.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.

• 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: 24317825
• Report Number: 2135147-2026-00843
• Device Sequence Number: 4863389
• Product Code: MAE
• UDI-Device Identifier: 00811806011110
• UDI-Public: (01)00811806011110(17)280430(10)9061221
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/11/2026

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-004
• Device Catalogue Number: 9-PDA-004
• Device Lot Number: 9061221
• 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: 01/17/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2023
• 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: 8F AMPLATZER TORQVUE DELIVERY SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Sex: Female