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

Model Number	9-PDAP-04-06-L
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Migration (4003)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that a 4/6mm amplatzer piccolo occluder was selected for implant in a (b)(6) month old, (b)(6) kg patient on (b)(6) 2021.The patient had the following patent ductus arteriosus(pda) dimensions: minimal diameter of 2.3mm, length of 9.8mm and a diameter at the aortic ampulla of 2.3mm.During the procedure the device was successfully placed intraductal with extraductal placement of the pulmonary disc.5 to 6 hours post-procedure, it was noted that the device migrated from the implant site(pda) into a branch of the pulmonary aorta.The patient underwent surgical removal of the device and surgical closure of the pda.The patient is currently stable and the device has been discarded.No additional information was provided.
Additional Manufacturer Narrative
An event of migration of the 4/6mm piccolo device was reported.A more comprehensive 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.The cause of the reported event could not be conclusively determined.A capa was initiated for further investigation on the device migration, per internal procedures.Please note per the instruction for use, arten600042307 version a, sizing chart t2, the recommended size devices for patients >2kg have a maximum duct length of 8mm, and therefore the 9.8mm pda of the reported event falls outside recommended sizing.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11989082
• Report Number: 2135147-2021-00236
• Device Sequence Number: 4329016
• Product Code: MAE
• UDI-Device Identifier: 05415067031020
• UDI-Public: 05415067031020
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 9-PDAP-04-06-L
• Device Catalogue Number: 9-PDAP-04-06-L
• Device Lot Number: 7482392
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/13/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 MO
• Patient Weight: 6