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

Model Number	9-PDA-007
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on 09 april 2025, a 12-10mm amplatzer duct occluder was selected for a procedure using a 7f amplatzer torqvue delivery system to treat a patent ductus arteriosus (pda).The pda was measured at 21.6mm.The sizing of the device was determined with intracardiac echocardiography (ice).Fluoroscopy and ice were used during the procedure.During deployment the occluder moved to the pulmonary side.An attempt was made to partially re-capture the occluder and re-deploy, however the occluder could not be partially re-captured to the delivery system.Upon the third attempt to re-capture the occluder, the occluder prematurely detached from the delivery cable and embolized to the right pulmonary branch.The patient remained hemodynamically stable throughout the procedure but was noted to have lost a small amount of blood.The patient was transferred to surgery to remove the occluder.The patient status was stable.
Additional Manufacturer Narrative
An event of device migration (embolization), during the implant procedure 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 specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received and without the device to analyze, the cause of the reported embolization is likely due to the retraction problem and premature separation of device that led to the device embolization.However, this could not be conclusively determined.The reported bleeding was a result of case-specific circumstances, the patient was taken to the operating room for surgery to remove the embolized occluder.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.From cine review: a 1 second video clip was provided of a partially recaptured occluder.No imaging of the embolized occluder was provided.Full procedure imaging would need to be provided to confirm the event.

• 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: 22052943
• Report Number: 2135147-2025-02647
• Device Sequence Number: 14788024
• Product Code: MAE
• UDI-Device Identifier: 00811806011141
• UDI-Public: (01)00811806011141(17)290531(10)10400068
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 06/30/2025

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-007
• Device Catalogue Number: 9-PDA-007
• Device Lot Number: 10400068
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 12-10MM AMPLATZER DUCT [9-PDA-007 LOT: 10400068],
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 22 KG