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	Obstruction/Occlusion (2422)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 5mm x 2mm amplatzer piccolo was chosen for implanted using an unknown delivery system.On (b)(6) 2025, migration of the device toward the aorta was identified, with obstruction noted on echocardiography.The patient was brought to the catheterization laboratory, and the device was retrieved percutaneously without incident.A subsequent echocardiogram confirmed closure of the patent ductus arteriosus (pda).No additional device implantation was done.Patient currently is in nicu.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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 with obstruction 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 could not be determined.The reported obstruction is likely a cascading effect of the event.An unexpected medical intervention (snaring of device) and prolonged hospitalization are results of case-specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 5mm x 2mm amplatzer piccolo was chosen for implanted using a 4f tvlp catheter.The sizing of the device was determined based on ifu sizing chart guidance and physician decision.The patient had a patent ductus arteriosus (pda) with dimensions of ao ampulla 4.8 mm, length 6.6 mm, and pa end 3.2 mm.Imaging modalities used during the procedure included angiography and transthoracic echocardiogram (tte).A stability check was performed, and no difficulty with implantation such as multiple recaptures or repositioning was noted.Initially, a 4-2mm amplatzer piccolo device was attempted, but tte revealed a residual shunt; this device was removed and it was never released and was upsized, and a 5-2 mm amplatzer piccolo device was placed with no leak detected.On (b)(6) 2025, migration of the device was identified, with the posterior disk protruding into the descending aorta, causing obstruction noted on echocardiography.Migration was first suspected on chest x-ray and confirmed by tte.The device had shifted within the intended implant site rather than completely dislodging.The implanter believes migration occurred after hemodynamic instability in the nicu post-catheterization.The patient was brought to the catheterization laboratory, and the device was retrieved percutaneously using a 5 mm non-abbott snare from the pulmonary end (via femoral vein) with a 5f non-abbott sheath, without incident.A subsequent echocardiogram confirmed closure of the pda, most likely due to mechanical disruption of the duct during device retrieval.No additional device implantation was performed.No thrombus formation or tissue reaction was noted, and the duct had no flow after device retrieval.The patient remained hemodynamically stable throughout the retrieval procedure, although prior nicu course included hemodynamic instability in the setting of other comorbidities such as severe aortic valve stenosis, bicuspid aortic valve, and decreased ventricular function.There were no rhythm changes during the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The reason for pda closure was attributed to prematurity (27-week gestation) and left heart enlargement.

• 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: 23729951
• Report Number: 2135147-2025-07205
• Device Sequence Number: 10594070
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: (01)05415067031037(17)291231(10)10680561
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 02/16/2026

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: 11/12/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/16/2026
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 1 MO
• Patient Sex: Male
• Patient Weight: 2 KG