• 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 RONYX45012X
Device Problems Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Material Deformation
Event Date 12/18/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

A resolute onyx rx drug eluting stent was intended to be used during a procedure. The target lesion was at the proximal rca with moderate calcification and severe tortuosity. No damage noted to device packaging and no issues removing the device from the hoop/tray. The device was inspected with no issues noted. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was encountered while advancing the device to the target lesion. Excessive force was not used during attempted delivery. Stent dislodgement was reported to have occurred during removal of the device following failed delivery. When stent was prepositioned at the proximal rca, with moderate exertion due to tortuosity of the vessel, it was realized that the stent was long for the lesion. The stent system was removed but it was suddenly realized that the stent was no longer there. Upon checking the location of where stent that was supposed to be dislodged, stent was nowhere to be found. No injury to the patient reported. The procedure was completed with a shorted drug eluting stent.

 
Manufacturer Narrative

Product analysis summary: stent was positioned between the markerbands but not meeting specifications due to deformation of the proximal wraps. Deformation was evident to the 12th distal stent wraps with struts raised. No deformation was evident to the distal tip. The inner lumen patency could not be verified with a 0. 015 inch mandrel most likely due to hardened blood in the guidewire lumen. No other damage evident to the remainder of the device. The device returned with stent in position on balloon. It was reported that the correct device returned, and stent dislodgement was reported in error. 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 Key8273361
Report Number9612164-2019-00299
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRONYX45012X
Device LOT Number0009184183
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/06/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/12/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-