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

Model Number 9-ASD-024

Device Problem Biocompatibility (2886)

Patient Problem Complete Heart Block (2627)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

An event of heart block during the implant procedure 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, a 24mm amplatzer septal occluder was selected for implant.During the procedure, the patient developed a heart block upon device deployment.The device was re-captured and removed from the patient.The patient returned to sinus rhythm without further intervention, but the procedure was aborted.The physician noted that the patient had a condition which predisposes them to cardiac arrythmias and does not allege a device malfunction.The patient was reported to be stable.

• 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9763891
• MDR Text Key: 181826434
• Report Number: 2135147-2020-00081
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010199
• UDI-Public: 00811806010199
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 6594483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2018
• 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): Congenital Anomaly; Other
• Patient Age: 5 YR
• Patient Weight: 16