• 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 RONYX20018X
Device Problems Inflation Problem; Migration or Expulsion of Device ; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated
Event Date 08/20/2018
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a mildly calcified lesion located in the distal lad. The device was inspected with no issues. Negative prep was performed with no issues. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device. Excessive force was not used during delivery. It was reported that there were inflation difficulties during stent deployment when inflating to nominal pressure. The stent was then inflated to 16atm and became dislodged into the radial artery. The dislodged stent was removed surgically. The patient is reported to be alive with no injury.

 
Manufacturer Narrative

The issue was not that the device could not expand fully in the lesion due the vessel morphology. The issue was that the device did not expand fully based on the inflation pressure applied. The stent dislodged during positioning at the lesion. The stent migrated into the radial artery. The same inflation device was used with other devices pre and post the inflation difficulties. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

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

 
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 Key8105852
Report Number9612164-2018-03371
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2019
Device Catalogue NumberRONYX20018X
Device LOT Number0008920870
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 Received01/29/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/14/2017
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: 11/27/2018 Patient Sequence Number: 1
-
-