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	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, an 8-6mm amplatzer duct occluder was selected for implant using a 7f amplatzer torqvue delivery system.The defect measure 4x4.The sizing of the device was measured via computed tomography (ct) and angiogram; fluoroscopy was utilized during implant.During implant, stability check was performed and no leak was observed; the occluder was released from the delivery cable.After the occluder was released, it dislodged and embolized into a branch of the right pulmonary artery.The device did not cause blockage.The occluder was retrieved using bioptome forceps and successfully removed from the patient.The physician believed that they had "inadvertently retracted the retaining skirt into the sheath" when they were "pulling back to seat it on the ampulla, thus placing it within the duct instead of at the ampulla." "the physician does not believe sizing was an issue." no device was ultimately implanted.No patient consequences were reported.
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 device migration (embolization) during the implant was reported.Abbott requested for imaging of the procedure, but this was not provided by the site.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.The physician believes they may have inadvertently retracted the device too far while pulling back for tension, thinking that the device was still in the correct place.It is possible that procedural condition could have contributed to this event.However, this cannot be confirmed.The reported unexpected medical intervention of removing the device was a result of case-specific circumstances as the device was scheduled to be snared.There is no indication of a product quality issue with regards 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: 22285452
• Report Number: 2135147-2025-03274
• Device Sequence Number: 15535611
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: (01)00811806011127(17)290930(10)10577589
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/19/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-PDA-005
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 10577589
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 08/09/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female