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

Model Number	9-PDAP-05-06-L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Coronary obstruction/occlusion (4871)
Date of Event	09/20/2025
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 (b)(6) 2025, a 5 mm x 6 mm amplatzer piccolo occluder was chosen for a patent ductus arteriosus (pda) closure procedure using an unknown delivery system.The patient's age at time of procedure was 4 month and the patient's gestational age was 24 weeks.The patient's weight was 3k.The pda minimal diameter was 3.9mm and pda diameter at aortic ampulla was 4.1mm and pda length 8.9mm.The size of the defect was 3.9mm x 8.9.The sizing of the device determined by transthoracic echocardiogram (tte).The occluder was successfully implanted and stability check was performed.There was a peri device leak.Next day, it was noted that the device was embolized and causing obstruction partial to the right pulmonary artery (rpa).The cause of embolization was mis-sizing.The occlder was explanted via percutaneous retrieval and a new 5-4mm amplatzer duct occluder was implanted.The patient was reported stable.
Additional Manufacturer Narrative
An event of device embolization one day after the implant procedure was reported.The device was returned and the investigation confirmed that the device met the dimensional specifications when analyzed at abbott.Information from the field indicated that the migrated device partially obstruction to the right pulmonary artery.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause of the reported device embolization could not be conclusively determined.It is possible that sizing of the device contributed to the reported event; however, this cannot be confirmed.The reported unexpected medical intervention was a result of case-specific circumstances as the device was attempted to be snared and a new 5-4 mm amplatzer duct occluder was implanted.The patient was reported stable.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: 23303043
• Report Number: 2135147-2025-05861
• Device Sequence Number: 10107424
• Product Code: MAE
• UDI-Device Identifier: 05415067031051
• UDI-Public: (01)05415067031051(17)280229(10)8935587
• Combination Product (Y/N): N
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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-05-06-L
• Device Catalogue Number: 9-PDAP-05-06-L
• Device Lot Number: 8935587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2023
• 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: Disability; Hospitalization; Required Intervention
• Patient Age: 4 MO
• Patient Sex: Male