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

Catalog Number	9-PDAP-04-02-L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Adult Respiratory Distress Syndrome (1696)
Date of Event	07/24/2023
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 (b)(6) 2023 a amplatzer piccolo occluder 4 mm x 2 mm was implanted in a patient with a history of chronic lungs disease.The duct measurements was ao ampulla was 4.07 mm, 2.96 mm mid duct at a restriction point, and 3.54 mm at lpa end with a total ductal length of 11.23 mm.The device placed intraductal.On (b)(6) 2023, the patient passed away due to lung complications, the death was not caused by the piccolo.The physician reported that there were no allegations against the implanted device or any abbott product.The patient had considerable lung challenges prior to the piccolo implant procedure and following the placement of the piccolo device.The physician stated unfortunately the patient failed to improve post receipt of the piccolo device.The physician also stated there was some gradient in the left pulmonary artery (lpa) post placement of the piccolo device.The device was mainly functioning as intended.However, the device did protrude into the lpa slightly given the implanting physicians consideration to potentially perform a future intervention, but the babies health did not improve.This lpa gradient change on echocardiogram was not seen until 3 weeks post placement of the piccolo.The residual shunt was not considered acceptable by the physician.However no intervention was performed on the residual shunt due to the patients bilateral lung issues and significant comorbidities, the little remaining shunt was not thought to be a contributor given the overall issues the baby was experiencing.The physician made no allegations to the device causing this patients death.The lung disease was very significant prior to the piccolo implant and the lungs did not improve post placement of the device.The physician stated over the weekend the baby had received 3 chest tubes and was failing to improve and there was significant lung disease prior.
Additional Manufacturer Narrative
An event of device protruding into left pulmonary artery, residual shunt and patient death was reported.The patient had considerable lung challenges prior to the piccolo implant procedure and the lungs did not improve following the placement of the piccolo device.The device was reported to be functioning as intended.The patient passed away due to lung complications, and was not caused by the piccolo device.There was no intervention performed on the residual shunt due to the patients bi-lateral lung issues and significant co-morbidities.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 17558754
• Report Number: 2135147-2023-03579
• Device Sequence Number: 3454481
• Product Code: MAE
• UDI-Device Identifier: 05415067031006
• UDI-Public: 05415067031006
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/15/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDAP-04-02-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown
• Patient Weight: 2 KG