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U.S. Department of Health and Human Services

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

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AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM Back to Search Results
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.

 
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Brand NameAMPLATZER TORQVUE DELIVERY SYSTEM
Type of DeviceDELIVERY 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 Key5159623
MDR Text Key28626244
Report Number2135147-2015-00117
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeDA
PMA/PMN NumberK072313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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 Received10/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date02/28/2017
Device MODEL Number9-ITV07F180/80
Device Catalogue Number9-ITV07F180/80
Device LOT Number4534708
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/10/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/19/2015 Patient Sequence Number: 1
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