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 Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
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 that on (b)(6) 2025, a 4mm x 4mm amplatzer piccolo occluder was chosen for implant using an 4f amplatzer tvlp delivery system.The dimensions of the defect were 4.1 mm (aorta), 2.7 mm (pulmonary), and 7.5 mm in length.The sizing of the device was determined by angiography and transesophageal echocardiography.During the procedure it was noted that the occluder embolized.Angiography and transesophageal echocardiography were used during the procedure, and angiography identified the migration/embolization.The implanter believes the cause of embolization was difficulty in releasing the prosthesis, with twisting of the prosthesis within its own axis.It became known that the device had embolized during the procedure.The patient did not experience a rhythm change, and no leak was detected around the lobe of the device.An attempted percutaneous retrieval with snare was performed to address the embolization.The embolized device caused a partial or complete obstruction of blood flow and traveled to the distal branch of the right pulmonary artery.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• 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 ; +1(651)756-5400
• MDR Report Key: 23881544
• Report Number: 2135147-2025-07634
• Device Sequence Number: 9464761
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: (01)05415067031013(17)290630(10)10430737
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-PDAP-04-04-L
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 10430737
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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: 4F TVLP CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 MO
• Patient Sex: Unknown
• Patient Weight: 13 LB