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	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 5-4mm amplatzer pda occluder was chosen for implant using an abbott delivery system.The physician determined the sizing using fluoroscopy imaging, and the device was assessed to be mis-sized for the patient¿s patent ductus arteriosus (pda).The device was subsequently removed without being released from the delivery cable.The patient remained hemodynamically stable during this portion of the procedure, and no allegations regarding the sizing of this device were reported.A second device, a 6¿4 mm amplatzer pda occluder, was then selected.The sizing for this implant was determined using angiography, and fluoroscopy was used throughout the procedure.The physician determined this device to be the appropriate size and proceeded with deployment.Upon release, the device was observed to ¿jump¿ slightly toward the aorta, though it was noted to appear stable within the pda with no indications of migration at that time.No leak was believed to be present, and no rhythm changes or other clinical symptoms were reported during the procedure.No concerns related to significant delay or hemodynamic compromise were reported during the procedure.Several hours later, during a routine echocardiogram, the pda was observed to have full flow, indicating loss of occlusion.The patient was returned to the catheterization lab, where the second device was found to have completely dislodged, having embolized to the descending aorta, positioned above the pda.The device was successfully retrieved through the venous system by accessing the transverse portion of the aorta and the pda.The retrieval was not considered an emergency intervention, and the embolized device did not cause partial or complete obstruction of blood flow.The ductus was not closed following device extraction.The physician noted that the anatomy of the ductus was abnormal, and reported that the cause of embolization was believed to be mis-sizing or device location, given the device¿s jump toward the aorta upon initial release.The patient is recovering, and no additional concerns 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 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, the cause for the reported device embolization could not be determined.An unexpected medical intervention was a result of case-specific circumstances, as the device was removed via snare.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 5-4mm amplatzer pda occluder was chosen for implant using an abbott delivery system.The physician determined the sizing using fluoroscopy imaging, and the device was assessed to be mis-sized for the patient¿s patent ductus arteriosus (pda).The device was subsequently removed without being released from the delivery cable.The patient remained hemodynamically stable during this portion of the procedure, and no allegations regarding the sizing of this device were reported.A second device, a 6¿4 mm amplatzer pda occluder, was then selected.The sizing for this implant was determined using angiography, and fluoroscopy was used throughout the procedure.The physician determined this device to be the appropriate size and proceeded with deployment.Upon release, the device was observed to ¿jump¿ slightly toward the aorta, though it was noted to appear stable within the pda with no indications of migration at that time.No leak was believed to be present, and no rhythm changes or other clinical symptoms were reported during the procedure.No concerns related to significant delay or hemodynamic compromise were reported during the procedure.Several hours later, during a routine echocardiogram, the pda was observed to have full flow, indicating loss of occlusion.The patient was returned to the catheterization lab, where the second device was found to have completely dislodged, having embolized to the descending aorta, positioned above the pda.The device was successfully retrieved through the venous system by accessing the transverse portion of the aorta and the pda.The retrieval was not considered an emergency intervention, and the embolized device did not cause partial or complete obstruction of blood flow.The ductus was not closed following device extraction.The physician noted that the anatomy of the ductus was abnormal, and reported that the cause of embolization was believed to be mis-sizing or device location, given the device¿s jump toward the aorta upon initial release.The patient is recovering, and no additional concerns were reported.

• 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: 24405539
• Report Number: 2135147-2026-01078
• Device Sequence Number: 15495898
• Product Code: MAE
• UDI-Device Identifier: 00811806011110
• UDI-Public: (01)00811806011110(17)290831(10)10534874
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: 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?: No
• 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: 10534874
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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: 7 MO
• Patient Sex: Male
• Patient Weight: 7 KG