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

Model Number	OCCLUDER
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Obstruction/Occlusion (2422)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023 a 5 mm x 4 mm amplatzer piccolo occluder (lot#8428423) was chosen for implantation into 1 month old 3.1kg newborn utilizing a 4f delivery system for a patent ductus arteriosus closure (pda) procedure.The pda dimensions were 5.4 mm ampulla, 5.1 mm length pulmonary artery, and 2.1 millimeter pda.The device was successfully placed extraductal and was confirmed by imaging.Later the same day, on (b)(6) 2023, the piccolo device was confirmed via x-ray to have embolized from it's position.The next day, on (b)(6) 2023, a catheterization procedure was performed to retrieve the piccolo device which had become caught in a branch of the pulmonary artery (pa) in the lower back right lung.Attempts to retrieve the piccolo were unsuccessful for multiple hours.At one point the piccolo was caught, but then was dropped again in to the right pa periphery.Imaging showed that there was no blood flow in the peripheral part of the right pulmonary pa where piccolo was stuck.After trying multiple methods of retrieval, it was decided to perform a thoracotomy to retrieve the device and resolve the patient's pda.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay.
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 17 may 2023, a 5 mm x 4 mm amplatzer piccolo occluder (lot#8428423) was chosen for implantation into 1 month old, 3.1kg newborn utilizing a 4f amplatzer torqvue low profile catheter for a patent ductus arteriosus closure (pda) procedure.The pda dimensions were 5.4 mm at the aortic ampulla, 5.1 mm length of the pda, and 2.1 mm minimal diameter of the pda.The device was placed with one disc placed extraductal on the pulmonary artery side and one disc placed intraductal on the aortic side.The placement of the device was confirmed by imaging.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay.Later the same day, on (b)(6) 2023, the piccolo device was confirmed via x-ray to have embolized from it's position.The next day, on (b)(6) 2023, a catheterization procedure was performed to retrieve the piccolo device which had become caught in a branch of the pulmonary artery (pa) in the lower back right lung.Attempts to retrieve the piccolo were unsuccessful for multiple hours.At one point the piccolo was caught, but then was dropped again in to the right pa periphery.Imaging showed that there was no blood flow in the peripheral part of the right pa where piccolo was stuck.After trying multiple methods of retrieval, it was decided to perform a thoracotomy to retrieve the device and resolve the patient's pda.The patient's status was reported as stable.
Additional Manufacturer Narrative
An event of device embolization was reported.A returned device assessment could not be performed as the device and 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 specifications.Based on the information received, the cause of the reported incident could potentially be related to the user not following the recommended sizing chart provided in the ifu.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.A review of the ductal measurements as reported from the field was performed.Per the sizing table in the instructions for use, sizing chart t2, the recommended size device is 04-04 mm.

• 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: 17108511
• Report Number: 2135147-2023-02530
• Device Sequence Number: 6260131
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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 Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 8428423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2022
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 1 MO
• Patient Sex: Unknown