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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-ITV12F45/80
Device Problem Material Perforation (2205)
Patient Problems Death (1802); Pericardial Effusion (3271)
Event Date 08/24/2018
Event Type  Death  
Manufacturer Narrative

An event of cardiac perforation, effusion and patient death 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.

 
Event Description

This case was a "surgical turn down" due to the condition of the patient. During a procedure to close a post infarct ventricular septal defect (vsd), the defect was crossed using the standard method left to right technique to create an av loop. The device access was via transjugular approach. The 12f torqvue 45 delivery system (dtv45) was introduced and crossed through the defect to the right ventricle and then to the left ventricle over the guidewire. A 24 mm amplatzer p. I. Muscular vsd occluder (pimuscvsd) (lot: 6351799) was selected and deployed in an inferior apical defect. The left ventricular disc prolapsed through the defect without applying tension as the defect was large so the pimuscvsd device was removed and a 30 mm amplatzer septal occluder (aso) was then attempted to be used off-label. The dtv45 sheath was still in the right ventricle, however; the guidewire was no longer across the defect due to breaking the circuit to allow deployment of the 24mm pimuscvsd. The user decided that due to the size of the defect they would try and cross from the right ventricle to the left ventricle using a pigtail catheter and guidewire. The defect was crossed and the pigtail catheter was positioned in the aorta for stability. The echo cardiologist noticed that the dtv45 sheath had crossed the defect. The angle was different to the first position (sitting at the apex of the ventricle) and there was concern the user had gone through another defect, so sometime was spent checking the position of the dtv45 to confirm it was through the same defect. The left disc of the 30mm aso was deployed in the right ventricle, but at this time an effusion was noted on echocardiogram by the cardiologist. The aso was fully recaptured and the 12f amplatzer torqvue 45 delivery system was pulled back into the right side of the heart. The effusion was noted to have been caused by rupture of the free wall and the patient died during the procedure. The cause of the rupture of the free wall is unknown.

 
Event Description

This case was a "surgical turn down" due to the condition of the patient. During a procedure to close a post infarct ventricular septal defect (vsd), the defect was crossed using the standard method left to right technique to create an av loop. The device access was via transjugular approach. The 12f torqvue 45 delivery system (dtv45) was introduced and crossed through the defect to the right ventricle and then to the left ventricle over the guidewire. A 24 mm amplatzer p. I. Muscular vsd occluder (pimuscvsd) (lot: 6351799) was selected and deployed in an inferior apical defect. The left ventricular disc prolapsed through the defect without applying tension as the defect was large so the pimuscvsd device was removed and a 30 mm amplatzer septal occluder (aso) was then attempted to be used off-label. The dtv45 sheath was still in the right ventricle, however; the guidewire was no longer across the defect due to breaking the circuit to allow deployment of the 24mm pimuscvsd. The user decided that due to the size of the defect they would try and cross from the right ventricle to the left ventricle using a pigtail catheter and guidewire. The defect was crossed and the pigtail catheter was positioned in the aorta for stability. The echo cardiologist noticed that the dtv45 sheath had crossed the defect. The angle was different to the first position (sitting at the apex of the ventricle) and there was concern the user had gone through another defect, so sometime was spent checking the position of the dtv45 to confirm it was through the same defect. The left disc of the 30mm aso was deployed in the left ventricle, but at this time an effusion was noted on echocardiogram by the cardiologist. The aso was fully recaptured and the 12f amplatzer torqvue 45 delivery system was pulled back into the right side of the heart. The effusion was noted to have been caused by rupture of the free wall and the patient died during the procedure. The cause of the rupture of the free wall is unknown. Medical records, including echocardiogram reports, were requested from the hospital but have not been made available.

 
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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
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key7863949
MDR Text Key119804944
Report Number2135147-2018-00149
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 09/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2018
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2020
Device MODEL Number9-ITV12F45/80
Device Catalogue Number9-ITV12F45/80
Device LOT Number6202503
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 Received09/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/09/2017
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: 09/11/2018 Patient Sequence Number: 1
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