MAUDE Adverse Event Report: Abbott Medical Amplatzer Piccolo; Occluder, Patent Ductus, Arteriosus

Model Number	9-PDAP-03-02-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	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2026 a 3mm x 2mm amplatzer piccolo occluder was selected for implant.The patient had a ductus with a minimal diameter of 1.4mm and length of 7mm.Transthoracic echocardiogram (tte) and fluoroscopy were used during the procedure.Upon fully releasing the occluder from the delivery cable, the device embolized into the pulmonary artery.The patient experienced moderate tricuspid regurgitation (tr).The device was snared and removed from the patient, which resolved the tr.A 4mm x 2mm amplatzer piccolo occluder was implanted.The patient status was stable.The physician believed the compliant duct and steep angle of the patent ductus arteriosus takeoff caused the embolization.
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.

• 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: 50821207
• Report Number: 2135147-2026-06342
• Device Sequence Number: 13432146
• Product Code: MAE
• UDI-Device Identifier: 05415067030979
• UDI-Public: (01)05415067030979(17)300531(10)10908533
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• 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-03-02-L
• Device Catalogue Number: 9-PDAP-03-02-L
• Device Lot Number: 10908533
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 2 LB