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

Model Number OCCLUDER

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 04/11/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 5 mm x 4 mm amplatzer piccolo occluder was chosen for implant for a 1 month old, 1.3 kg patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter 3mm, diameter at aortic ampulla 3.8-4.0mm, and length of 12mm.The delivery sheath was a 4f amplatzer torqvue lp catheter.The pda closure was performed from the left internal jugular due to interrupted inferior vena cava access.The 5/4 piccolo occluder was placed in an intraductal position.On transthoracic echocardiogram, the aorta and left pulmonary artery were unobstructed.On (b)(6) 2023, it was reported that the reported that the device had migrated to the aorta.The patient expired.

Manufacturer Narrative

An event of device migration to aorta and patient death was reported.It was also reported that there was difficulty implanting the device.Information from field indicated that the cause of death was noted as reduced systemic flow in aorta.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.Please note that per the sizing table in the instructions for use, sizing chart t3, the recommended size devices for patient is (b)(4) amplatzer piccolo occluder.H6 health effect - clinical code: code 4580 removed.H6 medical device problem code: code 2993 removed.

Event Description

It was reported that on (b)(6) 2023, a 5 mm x 4 mm amplatzer piccolo occluder was chosen for implant for a 1 month old, 1.3 kg patient with the following patent ductus arteriosus (pda) dimensions: minimal diameter 3mm, diameter at aortic ampulla 3.8-4.0mm, and length of 12mm.The delivery sheath was a 4f amplatzer torqvue lp catheter.The pda closure was performed from the left internal jugular due to interrupted inferior vena cava access.The 5/4 piccolo occluder was placed in an intraductal position.On transthoracic echocardiogram, the aorta and left pulmonary artery were unobstructed.On (b)(6) 2023, it was reported that the reported that the device had migrated to the aorta.The patient expired.Subsequent to the previously filed report, additional information was received that it was noted that there was difficulty implanting the device.The cause of death was noted as reduced systemic flow in aorta.

• Brand Name: AMPLATZER PICCOLO
• Type of Device: 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: 16920363
• MDR Text Key: 315107939
• Report Number: 2135147-2023-02085
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 05415067031044
• UDI-Public: 05415067031044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-05-04-L
• Device Lot Number: 8782179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 1 KG