MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-030

Device Problem Unintended Movement (3026)

Patient Problem Cardiac Perforation (2513)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During an atrial septal defect closure, the defect was balloon-sized to 26 mm and a 30 mm amplatzer septal occluder was chosen.The initial placement showed the defect to be mostly occluded, but a small residual was seen near the rupv rim.The eustachian valve seemed to be entrapped in the aso.After retrieval and repositioning the defect seemed closed, and the eustachian valve free, while still attached to the delivery cable.Once the aso was released, there again appeared to be entrapment of the eustachian valve and a residual defect.The aso subsequently embolized to the right ventricle.The case was aborted and the patient was sent to surgery for aso removal and defect repair with a double layer 4-0 prolene suture line.During explant of the aso, the atrial septum was noted to have a tear and several perforations which were also closed with a separate double layer 4-0 prolene suture line.The patient was transported to the cicu in stable condition.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6110839
• MDR Text Key: 60288756
• Report Number: 2135147-2016-00110
• Device Sequence Number: 1
• Product Code: MLV
• 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: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 5318766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• 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