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	Coronary obstruction/occlusion (4871)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation.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 4 mm amplatzer piccolo occluder was chosen for a patent ductus arteriosus (pda) closure procedure.During procedure, the team believed the aortic (ao) disc may be protruding into the ao slightly so the device was removed without being released from cable.A new 5 mm x 2 mm amplatzer piccolo occluder was chosen, placed with no issue and released.Immediately after release, the device was noted to migrate towards the pulmonary artery (pa) with the pa disc and the center lobe protruding into the pa.Although there was still flow into the left pulmonary artery (lpa), it was determined the device was unstable and blocking too much flow so the device was retrieved and removed without incidence.The first 5 mm x 4 mm amplatzer piccolo occluder was placed again and released without incidence or obstruction of the ao or pa.The patient remained stable throughout and remains stable with no consequences.
Event or Problem Description
It was reported that on (b)(6) 2025, a 5 mm x 4 mm amplatzer piccolo occluder was chosen for a patent ductus arteriosus (pda) closure procedure using a 4f amplatzer torqvue low profile catheter.The patient's gestational age was 22.5 weeks.The pda minimal diameter was 3.6mm, the pda diameter at aortic ampulla was 4mm and pda length was 10mm.During procedure, the team believed the aortic (ao) disc may be protruding into the ao slightly so the device was removed without being released from cable.A new 5 mm x 2 mm amplatzer piccolo occluder was chosen, placed with no issue and released.Immediately after release, the device was noted to migrate towards the pulmonary artery (pa) with the pa disc and the center lobe protruding into the pa.Although there was still flow into the left pulmonary artery (lpa), it was determined the device was unstable and blocking too much flow so the device was retrieved via percutaneous retrieval and removed without incidence.The first 5 mm x 4 mm amplatzer piccolo occluder was placed again and released without incidence or obstruction of the ao or pa.The implanter believe was the cause of embolization was incorrect sizing.The patient remained stable throughout and remains stable with no consequences.
Additional Manufacturer Narrative
An event of migration or expulsion of device with patient effects of coronary obstruction / occlusion 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 defined manufacturing specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause for the reported migration or expulsion of device with patient effects of coronary obstruction / occlusion could not be determined.An unexpected medical intervention was a result of case-specific circumstances, as the device was successfully snared.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: 23745802
• Report Number: 2135147-2025-07215
• Device Sequence Number: 10208904
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: (01)05415067031037(17)291231(10)10680561
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/20/2026

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: 10680561
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• 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 Age: 1 MO
• Patient Sex: Unknown
• Patient Weight: 1 KG