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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 REL46
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Rupture (2208)
Event Date 06/11/2020
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 56mm abdominal aortic aneurysm. It was reported that during the index procedure, all the stent graft had been implanted successfully. The patient was noted to have a narrow distal aorta that measured 15mm. Following the implantation, the physician began using a reliant balloon in the narrow section of the aorta, utilizing the kissing balloon technique to assist in the expansion of the stent grafts. Once ballooning was completed at the narrowed aortic bifurcation, the physician was then notified that the patient was experiencing a sharp drop in blood pressure. The physician then inflated and placed the balloon above the celiac artery and completed several angiograms to determine was there an aneurysm rupture or a rupture of the graft. The only issue identified on angiogram was a late type ii endoleak. Meanwhile the patients bp continued to drop when the aortic occlusion balloon was not deflated. It was then decided to convert to open conversion to determine what was happening. Once the patient was opened it was determined an aortic rupture was present in the narrowed distal segment of the aorta. It was reported the bifurcate and limbs were intact and sealed adequately proximally and distally. The endurant stent grafts were explanted and replaced with a surgical bifurcate stent graft. As per the physician the cause was believed to be that one large lumbar artery was observed in close proximity of the aortic bifurcation and it was believed when using the kissing balloons in this area the aneurysm ruptured and because of the significant size of the lumbar artery, the retrograde perfusion was providing a large volume of blood loss via the ruptured aortic sac. No additional clinical sequelae were provided and the patient will be monitored.

 
Manufacturer Narrative

Additional information received; it was reported that the patient expired in the evening of the open aaa repair. The surgeon stated the patient had several underlying medical conditions that likely contributed to not being able to recover from the required open aaa repair. Other relevant devices are: rel46, lot number; 0010020882 use by date: 2021-11-17 ; upn # (b)(4). If information is provided in the future, a supplemental report will be issued.

 
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Brand NameRELIANT BALLOON
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
091708096
MDR Report Key10211201
MDR Text Key198680034
Report Number9612164-2020-02357
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
Report Date 08/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREL46
Device Catalogue NumberREL46
Device LOT Number0010020883
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 Received08/10/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/18/2019
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: 06/30/2020 Patient Sequence Number: 1
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