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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND RELIANT BALLOON CATHETER, PERCUTANEOUS Back to Search Results
Model Number AB46
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208); Insufficient Information (4580)
Event Date 05/18/2021
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

An endurant ii aui stent graft system was implanted in the patient for the endovascular treatment of a 79 mm abdominal aortic aneurysm. The patient was having an urgent evar for a symptomatic aaa. The patient had a heavily calcified distal aorta and iliac as well as calcium in a highly angulated neck. It was reported that during the index procedure, aui and limb were deployed but a large type 1a endoleak was noted. 15 endoanchors were implanted, but the endoleak type 1a persisted. An aortic cuff was then placed more proximally and ballooned aggressively with a reliant balloon. No endoleak was observed after placement of the cuff. It was stated that once the reliant balloon was deflated, patients' blood pressure immediately dropped. Angiogram was performed, where no endoleak was observed. However extravasation around the upper part of the stent graft and above the stent graft with no flow going into the aneurysm was noted. The balloon was placed supra celiac which stabilized the patient's blood pressure. Urgent explant of endurant grafts and open aorto-bi fem bypass was performed. As per the physician the cause of the event can not be determined. It was reported, the patient had multiple organ failure by the time they left the or.   palliative care was given until the family decided to stop treatment and the patient expired. No additional clinical sequelae were reported and the patient has expired.

 
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Brand NameRELIANT BALLOON
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 Key12007009
MDR Text Key256420811
Report Number9612164-2021-02331
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK050038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberAB46
Device Catalogue NumberAB46
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/18/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated By Manufacturer? Yes
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: 06/16/2021 Patient Sequence Number: 1
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