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

Catalog Number	9-PDAP-05-02-L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: (b)(6) as pms japan.It was reported that on (b)(6) 2023, a 5 mm x 2 mm amplatzer piccolo occluder was chosen for implant for a patent ductus arteriosus (pda).The minimal ductal diameter was 2.4mm, on echocardiography and 3.1mm on angiography.The maximum ductal diameter was 4.3mm, on echocardiography and 5.2mm on angiography.The ductal length of the pda was 5mm on echocardiography and 3.5mm on angiography.The piccolo occluder was successfully implanted.On (b)(6) 2023, it was noted that the flow velocity of the left pulmonary artery was accelerated up to 2.2 m/sec, which was clinically significant stenosis of the left pulmonary artery.This stenosis was caused by a partial obstruction from the piccolo occluder.It was not believed that the piccolo occluder migrated.The patient has been continuously monitored and has not had any symptoms.No treatment or intervention was performed or planned.The patient was reported to be in good condition.
Additional Manufacturer Narrative
An event of stenosis of the left pulmonary artery caused by a partial obstruction from the piccolo occluder was reported.A review of the ductal measurements as reported from the field was performed.Per the sizing table in the instructions for use, the recommended size is 04-02 amplatzer piccolo occluder.A returned device assessment could not be performed as the device remains implanted 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.

• 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: 17541788
• Report Number: 2135147-2023-03537
• Device Sequence Number: 20695263
• Product Code: MAE
• UDI-Device Identifier: 05415067031037
• UDI-Public: 05415067031037
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDAP-05-02-L
• Device Lot Number: 8527731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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: Other
• Patient Age: 8 DA
• Patient Sex: Female
• Patient Weight: 2 KG