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U.S. Department of Health and Human Services

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

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AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 9-ITV10F45/80
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Myocardial Infarction (1969); Renal Failure (2041)
Event Date 11/01/2018
Event Type  Death  
Event Description

An attempt was made to close a large post infarct vsd at the apex/rv free wall in an (b)(6) female patient, who was on balloon pump and in renal failure. The plan was to try and close the vsd with the largest device; however, the tissue around the defect was very poor. The user created an av loop and passed through the defect with a 10f amplatzer torqvue delivery system. Before the user was able to implant a device the rv free wall gave way and ruptured and the patient passed away on the table. The user does not believe the delivery system caused the rupture, as it was friable tissue.

 
Manufacturer Narrative

An event of patient death following a rupture in the rv free wall was reported. The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated that "the user does not believe the delivery system caused the rupture, as it was friable tissue. " the patient was (b)(6) years old and on balloon pump and in renal failure.

 
Event Description

An attempt was made to close a large post infarct vsd at the apex/rv free wall in an (b)(6)-year-old female patient, who was on a balloon pump and in renal failure. The plan was to attempt to close the vsd with the largest device; however, the tissue around the defect was very poor and friable. The user created an av loop and passed through the defect with a 10f amplatzer torqvue delivery system, however; before the user was able to implant a device the rv free wall gave way and ruptured and the patient passed away on the table. The user does not believe the delivery system caused the rupture, as the rv was friable following the infarct.

 
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Brand NameAMPLATZER TORQVUE DELIVERY SYSTEM
Type of DeviceCATHETER, PERCUTANEOUS
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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8063852
MDR Text Key126915680
Report Number2135147-2018-00209
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUK
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 12/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9-ITV10F45/80
Device Catalogue Number9-ITV10F45/80
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/13/2018 Patient Sequence Number: 1
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