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

Model Number 9-ITV07F180/80

Device Problems Malposition of Device (2616); Material Protrusion/Extrusion (2979)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Muscle Spasm(s) (1966); Rupture (2208)

Event Date 09/18/2015

Event Type  Death  

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.

Event Description

The patient's patent ductus arteriosus was accessed from the aortic side and a 6-6mm amplatzer duct occluder 2 (adoii) was deployed and released.The adoii was found to be protruding into the aorta after release.To facilitate removal of the adoii using a snare, the 5f amplatzer torqvue 180 delivery system (dtv180) was exchanged for a 7f dvt180 in the femoral artery.Through the larger sheath, the adoii was snared and removed without issue.It is reported prior to removal of a 7f short femoral sheath, the vessel developed spasms and treatment included the administration of pharmacology agents to stop the spasms.As the 7f short sheath was removed, a rupture of the iliac artery reportedly occurred and emergency surgery was required.The patient expired secondary to bleeding complications during the hospital stay.The exact cause of death and patient co-morbidities are unknown.The relationship of sjm devices to the need for surgical intervention is unclear.

Manufacturer Narrative

When this mdr was reported, the manufacturer of the short sheath was unknown.Per report received on october 20, 2015, it was learned the short sheath was a sjm manufactured 7f ultimum introducer.The amended event description based on additional information is as follows: the patient's patent ductus arteriosus was accessed from the aortic side and a 6-6mm amplatzer duct occluder 2 (adoii) was deployed and released.The adoii was found to be protruding into the aorta after release.To facilitate removal of the adoii using a snare, the 5f amplatzer torqvue 180 delivery system (dtv180) was exchanged for a 7f dvt180 in the femoral artery.Through the larger sheath, the adoii was snared and removed without issue.It was reported that prior to removal of an ultimum 7f short sheath from the femoral artery, the vessel developed spasms and treatment included the administration of pharmacology agents to stop the spasms.As the ultimum 7f short sheath was removed, a rupture of the iliac artery reportedly occurred and emergency surgery was required.The patient expired secondary to bleeding complications during the hospital stay.The exact cause of death and patient co-morbidities are unknown.The relationship of sjm devices to the need for surgical intervention is unclear.Note, the following three mdrs are related: mdr-2015-19055 -- this follow up report for the 7f amplatzer torqvue 180 delivery system.Mdr-2015-20693 -- report to follow for the 7f ultimum introducer.Mdr-2015-20687 -- report submitted for pdaii occluder.

• 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 ; 6517564470
• MDR Report Key: 5159623
• MDR Text Key: 28626244
• Report Number: 2135147-2015-00117
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K072313
• 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: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2017
• Device Model Number: 9-ITV07F180/80
• Device Catalogue Number: 9-ITV07F180/80
• Device Lot Number: 4534708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2014
• 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: 6 MO