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

Catalog Number	9-PDAP-05-06-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	01/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that a 5mm x 6mm amplatzer piccolo occluder was selected for implant on (b)(6) 2025 for a 15 week old patient with a weight of 6kg, and a minimal ductal diameter of 2.2mm and a ductal length of 6mm to treat a patent ductal arteriosus (pda).The patient was born close to full-term with a significant atrial septal defect (asd), pda, and vascular septal defect (vsd) and required 15 minutes of cardiopulmonary resuscitation (cpr) and resuscitation at birth.The patient also had tracheal intubation.Sizing of the device was determined with angiography.Fluoroscopy and echocardiogram were used during the procedure.During the procedure the occluder was placed from the aorta to the pulmonary artery and on the first deployment the occluder pulled through the ductus.The occluder was re-captured and re-deployed.Limited flow was observed on the superior side of the occluder and contrast injection done from the delivery catheter showed very little flow through and around the device.A tug test was performed and the user stated the occluder felt anchored in the pda by the patient's extra ductal disks.As the occluder was released the occluder embolized to the left pulmonary artery as observed through fluoroscopy.The occluder was snared and removed from the patient.The patient remained hemodynamically stable throughout the procedure.The patient did not present with any clinical signs or symptoms.The user believed the occluder disc was too small and soft for the ductus.The patient status was stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device was reported.A returned device assessment could not be performed as the device was not returned for analysis.It was believed the occluder disc was too small and soft for the ductus.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The angiography shows a window type ductus arteriosus with a minimal ductal diameter of 2.2 mm.Device positioning is with both discs extra-ductal.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.

• 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: 21334451
• Report Number: 2135147-2025-00609
• Device Sequence Number: 14395832
• Product Code: MAE
• UDI-Device Identifier: 05415067031051
• UDI-Public: (01)05415067031051(17)280731(10)9218167
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 03/11/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDAP-05-06-L
• Device Lot Number: 9218167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2023
• 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: Required Intervention
• Patient Age: 3 MO
• Patient Sex: Male
• Patient Weight: 6 KG