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

Model Number 9-PDAP-04-02-L

Device Problems Off-Label Use (1494); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2019

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 successfully implanted.2 hour post implant procedure, a murmur was noted and further evaluation was performed.Diagnostic imaging and echocardiography was performed and confirmed that the device embolized into the left pulmonary artery.The device was explanted and exchanged for a 6mm amplatzer vascular plug ii.The patient is reported to be stable condition and recovering.

Manufacturer Narrative

An event of embolization was reported.Four images were received from the field, showing the defect and the occlusion of the defect with the device.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Additional information for: g4, h2, h3, h6, and h10.An event of embolization was reported.Four images were received from the field, showing the defect and the occlusion of the defect with the device.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.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 4-6 piccolo, longer than the embolized device.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 incident could not be conclusively determined.

Event Description

On (b)(6) 2019, a 4-2 amplatzer piccolo was implanted in a 4 month old 5.4kg patient with the pda dimension: minimal diameter: 2.8mm, aortic : 3.9mm, length: 9mm) in the intrauctal.Two hours post implant procedure, a murmur was noted and further evaluation was performed.Diagnostic imaging and echocardiography was performed and confirmed that the device embolized into the left pulmonary artery.The patient remained asymptomatic.The device was snared and exchanged for a 6mm amplatzer vascular plug ii.The patient is reported to be stable condition and was discharged the next day.

• 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: 8739179
• MDR Text Key: 149345920
• Report Number: 2135147-2019-00188
• 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,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9-PDAP-04-02-L
• Device Catalogue Number: 9-PDAP-04-02-L
• Device Lot Number: 6944725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• 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; Required Intervention
• Patient Age: 4 MO
• Patient Weight: 5