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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); Embolism (1829)
Event Type  Injury  
Manufacturer Narrative

Additional codes: c9445, c50713, c50579. 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 20 years, who has used the reliant device for expansion of vascular prostheses 25 times in total of which 22 of those times were in the last 12 months. For temporary occlusion of large vessels it was used 25 times in total of which 12 of those times were 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 fol lowing complications were encountered; respiratory failure (pulmonary embolism) , entry site hematoma (significant diameter of the catheter (on the french catheter scale, i. E. The diameter of catheters in millimeters. ), aneurysm (paraprosthetic endoleak) , emboli (peripheral embolism despite distal protection mechanism), stent graft migration caused by balloon catheter device (migration of the prostheses because of unfavorable anatomy) , kink in the balloon (transfer to a flat surface). The physician found the respiratory failure very concerning and not at all concerning, the entry site haemtoma somewhat concerning and not at all concerning, the aneurysm somewhat concerning, the emboli very concerning, the stent graft migration not at all concerning, the kink in the balloon not at all concerning, all of the adverse events above, none were reported to be related to the device itself. During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; stroke (cerebral embolism) , aneurysm rupture (aneurysm fixing which required a covered stent implant (endoprosthesis) , balloon rupture (rupture because of use of high air pressure). The physician found the stroke events very concerning, the aneurysm rupture very concerning, the balloon rupture very concerning. The balloon rupture event was deemed to be related to the device itself. 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.

 
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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 Key10024983
MDR Text Key190380399
Report Number9612164-2020-01768
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeIT
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 06/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/05/2020
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 Received06/03/2020
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: 05/05/2020 Patient Sequence Number: 1
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