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

Model Number	OCCLUDER
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
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 (b)(6) 2022, a 4/6 amplatzer piccolo was successfully implanted in a (b)(6), (b)(6) patient in the intraductal position.The patient had the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 1.9 mm, pda length of 10-12 mm and diameter at aortic ampulla of 5.3 mm.Overnight, the device had became embolized and traveled into the distal left pulmonary artery (lpa).In an emergency procedure on (b)(6) 2022, the device was removed via transcatheter snare to resolve the event.The patient remained hemodynamically stable throughout and is currently stable.The physician alleges the cause of the event to be due to the device being undersized.It was unknown if the device was replaced.
Additional Manufacturer Narrative
An event of embolism of a 4/6mm piccolo device was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, the duct was longer than the sizing chart included for patients larger than 2ks, measuring at 11mm, and that the device diameter selected (4mm) was larger than recommended for a minimal ductus diameter of 1.9mm (3mm).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.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: 13911532
• Report Number: 2135147-2022-00102
• Device Sequence Number: 4049663
• Product Code: MAE
• UDI-Device Identifier: 05415067031020
• UDI-Public: 05415067031020
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 05/20/2022

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: 12/31/2025
• Device Model Number: OCCLUDER
• Device Catalogue Number: 9-PDAP-04-06-L
• Device Lot Number: 7789872
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• 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: Life Threatening; Required Intervention
• Patient Age: 8 MO
• Patient Sex: Unknown
• Patient Weight: 6 KG