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 Code	Obstruction/Occlusion (2422)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
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 an unknown date, a 5 mm x 4 mm amplatzer piccolo occluder was implanted in a patient with the following measurement: 3.1 mm in diameter on the aortic end and 2.5 mm on the pulmonary atresia (pa) end, with a length of 7mm.Post procedure, after leaving procedure room device migrated and caused aortic obstruction with 2.1 m/s gradient.The infant was managed with placement of a stent in the aorta and is doing well.
Event or Problem Description
It was reported that on (b)(6) 2023, a 4 mm x 4 mm amplatzer piccolo occluder was implanted in a patient with the following measurement: patent ductus arteriosus (pda) diameter on the pulmonary artery end was 1.5 mm and on the aortic end was 3.2 mm.The overall pda length was 7.8 mm.The piccolo device was positioned within the pda.Post-implant, the infant developed an aortic obstruction with 2.1 m/s gradient.It was noted that the device migrated.The patient was taken to the catheterization laboratory on post-operative day nineteen (19) for placement of a stent within the aorta without complications.The infant remains stable following stent placement and is being managed in the neonatal intensive care unit.It was noted that the patient status was stable.
Additional Manufacturer Narrative
An event of device migration 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 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.Two images were received from the field.The 04-04 device appeared to be implanted intra-ductal.The pulmonic disc had a ¿football¿ configuration with concern for oversizing and the position of the superior edge of the aortic disc was close to the aortic lumen.There were no complaints associated with any other devices from the lot.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.Please note that per the sizing table t3 in the instructions for use, the recommended size device for patient <2kgs is 03-02 piccolo occluder.

• 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: 16976499
• Report Number: 2135147-2023-02244
• Device Sequence Number: 11398704
• Product Code: MAE
• UDI-Device Identifier: 05415067031013
• UDI-Public: 05415067031013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/27/2023

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 Expiration Date: 04/30/2026
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-04-04-L
• Device Lot Number: 7988055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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 Sex: Unknown
• Patient Weight: 980 KG