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

Model Number	9-PDA2-04-04
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
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 (b)(6) 2025, a 04- 04 amplatzer adoii was chosen for implant using an 4f amplatzer tvlp delivery system.It was observed that the device embolization was noted during the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
Event or Problem Description
It was reported that on (b)(6) 2025, a 04- 04 amplatzer adoii was chosen for implant using an 4f amplatzer tvlp delivery system.The defect was measured prior to the procedure, with dimensions of 12.3 mm in length, 9.5 mm in diameter at the aorta, and 3.2 mm in diameter at the pulmonary artery, as determined by ct scan.During the procedure, angiography was utilized as the imaging modality.The device was deployed; however, embolization was observed intraprocedurally.Imaging confirmed the migration using angiography, and it was noted that the device had completely dislodged from the intended implant site.The implanter reported that the cause was not attributed to the device itself, but rather to an attempt to push the device after release, which resulted in dislodgement.Throughout the procedure, the patient remained hemodynamically stable, with no rhythm changes and no leak detected around the lobe of the device.There were no clinical signs or symptoms during or after the event, and no clinically significant delay in the procedure.Difficulty was encountered during implantation because the actual dimensions were smaller than those measured by ct scan, making positioning challenging.To address the embolization, percutaneous retrieval using a loop was performed successfully.The embolized device did not cause any obstruction or blockage of blood flow and was found to have migrated to the aorta.The patient experienced no adverse effects as a result of this event.
Additional Manufacturer Narrative
An 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 is likely related to the attempt to push the device after release.An unexpected medical intervention was a result of case-specific circumstances, as the device was snared.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 4624.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• 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: 23881824
• Report Number: 2135147-2025-07639
• Device Sequence Number: 15858803
• Product Code: MAE
• UDI-Device Identifier: 00811806011202
• UDI-Public: (01)00811806011202(17)300131(10)10735342
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/25/2026

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-PDA2-04-04
• Device Catalogue Number: 9-PDA2-04-04
• Device Lot Number: 10735342
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2025
• 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 Sex: Unknown