• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation (2001); Rupture (2208)
Event Type  Injury  
Manufacturer Narrative

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 21 years, who has used the reliant device for expansion of vascular prostheses 600 times in total over the last 15 months and 300 times in the last 12 months and for temporary occlusion of large vessels 400 times in total over the last 15 months and 200 times in the last 12 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; hematoma (very old patients with very fragile case or difficult puncture), vessel perforation or dissection (very old patients), stroke (patient with a lot of arteriosclerosis), haemorrhage(anticoagulated or very old patients), death (very dilated aneurysms), balloon catching inside of graft during catheter movement (complex procedure) and balloon rupture (a lot of calcium in the vessel). The physician found the death events very concerning, hematoma events were somewhat or not at all concerning, vessel perforation or dissection, stroke, balloon catching inside of graft during catheter movement and balloon rupture very or somewhat concerning and the haemorrhage events to be very, somewhat or not at all concerning. All of the adverse events and the balloon catching and balloon rupture events were reported to be related to the device on at least one occasion, the death events were reported to be not related to the device. During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; vessel perforation or dissection (very old, complete anatomy), stroke (significant arteriosclerosis), aneurysm rupture (very dilated aneurysm), death (significant comorbidity), stent graft migration caused by balloon catheter device (significant calcification). The physician found the death events very concerning, vessel perforation or dissection, aneurysm events very, somewhat or not at all concerning, stroke, stent graft migration very or somewhat concerning. All of the 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10003991
MDR Text Key196863876
Report Number9612164-2020-01694
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeSP
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 06/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2020
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

Patient TREATMENT DATA
Date Received: 04/28/2020 Patient Sequence Number: 1
-
-