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

Model Number	9-PDAP-04-04-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 4 mm x 4 mm amplatzer piccolo occluder was chosen for implant using an unknown delivery system.During the procedure, upon releasing the device, it was noted that the device embolized into the main pulmonary artery.The device was completed using a 5mm x 2mm amplatzer piccolo occluder.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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 (b)(6) 2025, a 4 mm x 4 mm amplatzer piccolo occluder was chosen for implant using an unknown delivery system.The defect measured 3.4/3.2/3.1/4.1/11 mm, with multiple measurements obtained due to the shape of the defect and to determine the optimal implant location.Fluoroscopy and tte were used during the procedure.During device deployment, upon releasing the device, it was noted under fluoroscopy that the device embolized into the main pulmonary artery.The device completely dislodged from the intended implant site.The implanter reported the cause of the embolization as unknown.The patient remained hemodynamically stable throughout the procedure, and no rhythm changes were observed.There was no leak detected around the lobe of the device, and no clinical signs or symptoms were noted during or after the event.To address the embolization, the device was retrieved through the same access point, and no obstruction of blood flow was reported.The embolized device had traveled to the main pulmonary artery.Retrieval was performed urgently but without adverse events.A replacement device was used; however, although a 5¿2mm amplatzer piccolo occluder , 4¿2 mm amplatzer piccolo occluder, and 4¿4 piccolo device were attempted, a non-abbott device was ultimately implanted successfully.The procedure was completed without clinically significant delay and with no adverse patient effects reported.
Additional Manufacturer Narrative
An event of device embolization into the main pulmonary artery 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.Based on the information received, the cause of the reported device embolization could not be conclusively determined.The unexpected intervention is result of retrieval of embolized device through the same access point.Retrieval was performed urgently but without adverse events.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER PICCOLO
• 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: 24038244
• Report Number: 2135147-2026-00244
• Device Sequence Number: 13030416
• Product Code: MAE
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/25/2026

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-PDAP-04-04-L
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 10844622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 2 LB