MAUDE Adverse Event Report: AGA MEDICAL CORPORATION DELIVERY SYSTEM ITV 10F 45/80 US

Model Number 9-ITV10F45/80

Device Problems Retraction Problem (1536); Inadequacy of Device Shape and/or Size (1583); Physical Resistance (2578)

Patient Problem Death (1802)

Event Date 07/13/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

A 10f amplatzer torqvue 45 delivery system (dtv45) and a 30 mm amplatzer septal occluder (aso) were selected for use.Upon deployment of the aso it was determined the defect size was too large for closure by the 30 mm aso.Attempts to retract the aso into the dtv45 sheath encountered resistance and the aso did not retract into the sheath easily.The aso and delivery sheath were removed from the patient and the case was aborted.The patient died the next day due to cardiac shock of unknown origin, however, the physician did not allege this event was caused by the device.

Manufacturer Narrative

(b)(4) the results of this investigation confirmed the 10f amplatzer torqvue delivery system was able to successfully hand-off, advance, and retract the returned 30 mm amplatzer septal occluder.A review of the device history record confirmed the delivery system met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the delivery system, and the cause for the difficulty retracting the occluder during the procedure remains unknown.

Event Description

This patient had a myocardial infarction which was the cause for the rupture of the ventricular septum.A 10f amplatzer torqvue 45 delivery system (dtv45) and a 30 mm amplatzer septal occluder (aso) were selected for use.Upon deployment of the aso it was determined the defect size was too large for closure by the 30 mm aso.Attempts to retract the aso into the dtv45 sheath encountered resistance and the aso did not retract into the sheath easily.The aso and delivery sheath were removed from the patient and the case was aborted.The patient died the next day due to cardiac shock and multiple organ failure.The physician did not allege this event was caused by the device.

• Brand Name: DELIVERY SYSTEM ITV 10F 45/80 US
• 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 ; 6517564470
• MDR Report Key: 4997326
• MDR Text Key: 22804815
• Report Number: 2135147-2015-00088
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K072313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 9-ITV10F45/80
• Device Catalogue Number: 9-ITV10F45/80
• Device Lot Number: 4917624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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): Death
• Patient Age: 87 YR