• 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 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING

  • 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 RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number RONYX22522X
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2016
Event Type  Malfunction  
Manufacturer Narrative

Product analysis: there were numerous kinks along the hypotube. There was a kink on the distal shaft 11. 4cm distal to the guidewire entry port. The stent was positioned on the balloon between the markerbands as per specifications. There was deformation to the 17th, 18th, 19th and 20th distal stent wraps with struts bunched and raised. There was misalignment of stent struts on the 6th and 7th distal stent wraps. There was no deformation to the distal tip. (b)(4).

 
Event Description

The physician intended to use a resolute onyx device, to treat a moderately tortuous rca with severe calcification and 80% stenosis. No damage was noted to the packaging. Device was inspected with no issues noted. Lesion was pre-dilated. It is reported that the device passed through a previously-deployed stent. It is reported that stent deformation occurred in vivo during positioning / advancement. Procedure was completed with another device. The physician believes that the event was due to use of the device in difficult lesion morphology/anatomy, i. E. The event was procedural related and not device related. No patient injury reported. Please note that this device resolute onyx is not marketed in the united states; however, it is similar to the united states marketed device resolute integrity. This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

 
Manufacturer Narrative

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

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESOLUTE ONYX RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6192576
MDR Text Key62913891
Report Number9612164-2016-01346
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeTU
PMA/PMN NumberP110013
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 12/08/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/06/2016
Device Catalogue NumberRONYX22522X
Device LOT Number0007395273
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/15/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/07/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-