• 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 REL46
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Rupture (2208)
Event Date 07/15/2020
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

An endurant ii bifurcate stent graft system was implanted in a patient for the endovascular treatment of an 66 mm abdominal aortic aneurysm. It was reported that the index procedure was performed without complication. Final angiogram was performed and an type ia endoleak was observed with no issues found in relation to the position of the stent graft components. The physician then tried ballooning the proximal graft edge with a reliant balloon. It was reported that an angiogram was performed after ballooning, aortic rupture was observed. Aortic occlusion was then obtained with a reliant balloon. It was stated that an endurant ii aortic extension ((b)(4)) was then placed at the level of the right renal artery covering the left renal artery and ballooned the extension with a reliant balloon. Physician was able to achieve seal with endoleak. It was reported that the patient's aorta ruptured again after the index procedure. As per the physician, cause of the event cannot be determined. No additional clinical sequelae were reported. The patient has expired.

 
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 Key10390576
MDR Text Key202367884
Report Number9612164-2020-02949
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 09/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberREL46
Device Catalogue NumberREL46
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 Received09/09/2020
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: 08/11/2020 Patient Sequence Number: 1
-
-