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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT STENT GRAFT BALLOON CATHETER -OUS CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND RELIANT STENT GRAFT BALLOON CATHETER -OUS CATHETER, PERCUTANEOUS Back to Search Results
Model Number REL46J
Device Problem Device Damaged by Another Device (2915)
Patient Problem Vascular Dissection (3160)
Event Date 12/22/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

An endurant ii stent graft was implanted in the endovascular treatment of a 50. 3mm abdominal aortic aneurysm. It was reported that during the index procedure, a type ia endoleak was noted at the time of final contrast radiography. It was stated that the stent graft was touched up with a reliant balloon, but the main body migrated into the aneurysm and then the stent graft was touched up multiple times near the stent, causing dissection below the right renal artery. It was reported that an extension aortic cuff was added and the endoleak disappeared, but the dissection remained. As per the physician, the cause of the event was user error. It was stated that too much balloon touch up was used. No additional clinical sequalae were provided and the patient will be monitored.

 
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Brand NameRELIANT STENT GRAFT BALLOON CATHETER -OUS
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key11177293
MDR Text Key227022208
Report Number9612164-2021-00195
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK050038
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 02/11/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREL46J
Device Catalogue NumberREL46J
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 Received01/19/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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: 01/15/2021 Patient Sequence Number: 1
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