MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-010

Device Problem Unintended Movement (3026)

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

Event Date 12/26/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 10mm amplatzer muscular vsd occluder was selected and not implanted, reason unknown.A 10mm amplatzer septal occluder was implanted in the ventricle septal defect after confirming stability with a tug test.The following day, x-ray revealed the device had embolized to the pulmonary artery.The patient was taken to surgery where the device was removed and the defect was closed using an 18mm amplatzer muscular vsd occluder.On (b)(6) 2018, the patient was discharged.

Manufacturer Narrative

An event of embolization was reported.The results of this investigation confirmed the device met dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown; however, information from the field indicated that a larger, 18mm muscular vsd occluder was subsequently implanted.Furthermore, per the instructions for use arten600039487 rev.B, "the amplatzer¿ septal occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects".

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8251288
• MDR Text Key: 133213427
• Report Number: 2135147-2019-00021
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010076
• UDI-Public: 00811806010076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 6311183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 103