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

Model Number	9-PDAP-05-02-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	06/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 5mm x 2mm amplatzer piccolo occluder was implanted.The ductal measurements were: ampulla 3.6mm, length 9.2mm, and pa measurement 3.2mm.Approximately 3 hours later, the device was found to have embolized into the main pa.The device was retrieved percutaneously and the duct was closed with a 6mm non-abbott device to resolve the event.The patient was transferred to the picu in stable condition.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The physician believes the device was potentially mis-sized as the cause of the event.
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.
Additional Manufacturer Narrative
An event of migration or expulsion of device 3hours post implanting the occluder was reported.A returned device assessment could not be performed as the device was not returned for analysis.Field indicated that the sizing of the device was determined by angiography.Field also indicated that there is a leak detected around the lobe of the device during the procedure and difficulty implanting the occluder.The user believed the cause of device embolization was due to potential mis size - needed longer device size.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 and per event details, the cause of reported event was due to mis-sizing but could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as snaring of device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a 5mm x 2mm amplatzer piccolo occluder was implanted.The ductal measurements were: ampulla 3.6mm, length 9.2mm, and pa measurement 3.2mm.Approximately 3 hours later, the device was found to have embolized into the main pa.The device was retrieved percutaneously and the duct was closed with a 6mm non-abbott device to resolve the event.The patient was transferred to the picu in stable condition.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The physician believes the device was potentially mis-sized as the cause of the event.

• 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: 22437162
• Report Number: 2135147-2025-03714
• Device Sequence Number: 4745694
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: (01)05415067031037(17)290630(10)10432055
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/09/2025

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-PDAP-05-02-L
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 10432055
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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: 1 MO
• Patient Sex: Male