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	12/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 12 december 2025, a 8-6mm amplatzer pda occluder was chosen for implant for patent ductus arteriosus (pda) closure.Initially, the physician attempted to use a 6 mm avp2 device, which was determined to be too small.A subsequent attempt with an 8 mm avp2 device also proved unsuitable.While the 8 mm avp2 device remained attached within the pda, a contrast injection was administered, and the pda defect was re-measured.The dimensions of the defect were reported as pa ampulla 4.37 mm, mid pda 4.97 mm, and aortic ampulla 9.21 mm.Following this assessment, the physician removed the avp2 device safely and successfully implanted an 8-6 mm amplatzer pda occluder using an unknown delivery system.The physician stated that the sizing of the device was determined based on fluoroscopic measurements with contrast injection.A stability check was performed prior to release, which included injecting contrast to view the opposition of the device to the defect and waiting for 10 minutes with the device attached to check for any changes.There were no recaptures of the ado1 device during implantation, and no rhythm changes occurred during the procedure.The device was not removed from the patient prior to release from the delivery cable.On (b)(6) 2025, x-ray imaging revealed that the 8-6 mm amplatzer pda occluder device had migrated into the right pulmonary artery (rpa), and the device was completely dislodged from the implant site.The physician reported that the patient was stable and planned to attempt retrieval later that day.The physician stated that they did not know the reason for migration and was unsure if they would have done anything differently.The physician also stated that they did not believe the sizing was incorrect, even though x-ray imaging the next day indicated migration, suggesting mis-sizing.In the afternoon, an attempt was made to snare and remove the device from the rpa, which was unsuccessful.On (b)(6) 2025, the patient went to surgery and had the device removed.
Event or Problem Description
It was reported that on (b)(6) 2025, a 8-6mm amplatzer pda occluder was chosen for implant for patent ductus arteriosus (pda) closure.Initially, the physician attempted to use a 6 mm avp2 device, which was determined to be too small.A subsequent attempt with an 8 mm avp2 device also proved unsuitable.While the 8 mm avp2 device remained attached within the pda, a contrast injection was administered, and the pda defect was re-measured.The dimensions of the defect were reported as pa ampulla 4.27 mm, mid pda 4.97 mm, and aortic ampulla 9.21 mm.Following this assessment, the physician removed the avp2 device safely and successfully implanted an 8-6 mm amplatzer pda occluder using an unknown delivery system.The physician stated that the sizing of the device was determined based on fluoroscopic measurements with contrast injection.A stability check was performed prior to release, which included injecting contrast to view the opposition of the device to the defect and waiting for 10 minutes with the device attached to check for any changes.There were no recaptures of the 8-6 mm amplatzer pda occluder device during implantation, and no rhythm changes occurred during the procedure.The device was not removed from the patient prior to release from the delivery cable.On (b)(6) 2025, x-ray imaging revealed that the 8-6 mm amplatzer pda occluder device had migrated into the right pulmonary artery (rpa), and the device was completely dislodged from the implant site.The physician reported that the patient was stable and planned to attempt retrieval later that day.The physician stated that they did not know the reason for migration and was unsure if they would have done anything differently.The physician also stated that they did not believe the sizing was incorrect, even though x-ray imaging the next day indicated migration, suggesting mis-sizing.The mis-sizing of the device was determined as the physician did not approve the compression that was visualized on the fluoro imaging and determined it was not the appropriate size or device.In the afternoon of (b)(6) 2025, an attempt was made to snare and remove the device from the rpa, which was unsuccessful.On (b)(6) 2025, the patient went to surgery and had the device removed.It was also reported that the patient was in stable condition after the device dislodgement and during the retrieval attempt process.
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, the cause for the reported device embolization likely resulted from a device mis-sizing.Medical interventions were a result of case-specific circumstances, as an unsuccessful attempt was made to snare the device, then it 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: 23995851
• Report Number: 2135147-2026-00171
• Device Sequence Number: 10522845
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: (01)00811806011127(17)270630(10)8557611
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 8557611
• 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: 12/13/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2022
• 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: 12 MO
• Patient Sex: Female