MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM

Model Number 9-ITV10F45/80

Device Problem Difficult To Position (1467)

Patient Problem Regurgitation (2259)

Event Date 05/05/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, an asd procedure was performed in this patient who was experiencing decreased exercise tolerance secondary to an atrial septal defect (asd).The defect measured 26 mm via toe and a 28 mm amplatzer septal occluder (aso) was chosen for implant.An amplatzer torqvue delivery system (dtv45) was used for the procedure.Difficulty was experienced seating the device in the la due to a poor aortic rim making alignment difficult.La roof technique was also attempted.The 28 mm aso was removed and a 26 mm aso was selected for use.During the procedure, it was noted what appeared to be tissue/clot flapping through the asd which was considered to be part of the secundum septum that may have torn during traction of the aso.The implant was aborted.On 06 may 2015, the patient underwent surgical procedure to close the asd.During the surgical procedure, the left atrial side adjacent to the aorta resembled a spider web, and the cardiologist believes during implant he got caught in this area.That section of septum was removed and the asd was closed.

Manufacturer Narrative

(b)(4).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 TORQVUE DELIVERY SYSTEM
• Type of Device: DELIVERY SYSTEM
• 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 ; 6517565400
• MDR Report Key: 4816076
• MDR Text Key: 5920749
• Report Number: 2135147-2015-00059
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 9-ITV10F45/80
• Device Catalogue Number: 9-ITV10F45/80
• Device Lot Number: 4900456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2014
• 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: 61