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

Model Number 9-PDAP-04-02-L

Device Problems Gradient Increase (1270); Obstruction of Flow (2423); Migration (4003)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 4/2mm amplatzer piccolo occluder was implanted in a premature baby born at (b)(6) weeks gestation and weighed (b)(6) kilograms.The infant had a history of enterocolitis related to prematurity.The device was successfully placed with no evidence of aortic or pulmonary protrusion.Post implant, an aortic obstruction and increase gradient was reported.One month post implant on (b)(6) 2019, it was reported that the device migrated slightly towards the aorta.The physician decided to continue to monitor the infant.The infant remains in the nicu in stable condition.

Manufacturer Narrative

An event of migration of the 04-02 piccolo occluder into the aorta was reported.The results of the investigation are inconclusive since 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, arten600042307 version a, the correct size piccolo occluder for the measurements provided was 04-02, the size of the implanted device.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Correction: d2.

• Brand Name: AMPLATZER PICCOLO OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9802234
• MDR Text Key: 183949205
• Report Number: 2135147-2020-00107
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDAP-04-02-L
• Device Catalogue Number: 9-PDAP-04-02-L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 1