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

Model Number 9-ASD-034

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  Injury  

Event Description

On (b)(6) 2018, a 34mm amplatzer septal occluder was implanted.Three months following the implant, the patient presented with chest pain.A toe was performed and revealed the device had moved posteriorly but was not completely dislodged.The device was explanted and a surgical patch was placed.The patient remained hemodynamically stable throughout the procedure and was stable post-operatively.

Manufacturer Narrative

An event of a dislodged device was reported.The results of the investigation are inconclusive since 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 8480062
• MDR Text Key: 140830160
• Report Number: 2135147-2019-00096
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: 00811806010243
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 6281436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 04/19/2019
• Date Device Manufactured: 01/17/2018
• 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): Required Intervention
• Patient Age: 23 YR