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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 Aneurysm (1708); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Rupture (2208)
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the reliant device. The exact size of the device is unknown. Survey results from an interventional cardiologist in practice 8 years, who has used the reliant device for expansion of vascular prostheses 20 in total over the last 5 months and for temporary occlusion of large vessels 40 times in total over the last 5 months. During use of the reliant for expansion of vascular prostheses (assisting in the expansion of self-expanding stent grafts), the following complications were encountered; vessel perforation or dissection (vessel rupture after stent implantation), paresthesia (sensitivity disturbances after procedure), stroke (neurological deficit after the procedure), aneurysm (expansion of the vessel walls after the procedure), haemorrhage(bleeding after the procedure), death (complications after the procedure), malposition (under or over -expansion after stent implant). The physician found the vessel perforation or dissection, aneurysm, death events very or somewhat concerning, paresthesia, stroke, malposition events very concerning, haemorrhage events not at all concerning, death (complications after the procedure), malposition (under or over-expansion after stent implant). All of the events were reported to be related to the device on at least one occasion. During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; stroke (neurological deficit after procedure), aneurysm rupture (vascular perforation after notified aneurysm), haemorrhage (bleeding in a vessel with complications), death (death after stent implant). The physician found the stroke, aneurysm rupture and death events somewhat or not at all concerning and the haemorrhage events very or not at all concerning. The aneurysm rupture events were reported to be not related to the device, all of the other events were reported to be related to the device on at least one occasion. Of the above complications reported, some of these are listed as having been reported to medtronic previously. Due to limited information these are included in reporting. No further information has or will be provided.

 
Manufacturer Narrative

Additional information received. It was reported that during the use of the reliant for expansion of vascular prothesis, the physician also encountered aneurysm ruptures (edge dissection on already implanted stent). The physician found these events very concerning, somewhat concerning and not at all concerning. These events were reported to be related to the device itself on at least one occasion. 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 Key10009254
MDR Text Key196759574
Report Number9612164-2020-01717
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
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 06/12/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/29/2020
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
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

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