• 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 RONYX40038X
Device Problems Migration or Expulsion of Device ; Device Dislodged or Dislocated; Material Deformation
Event Date 07/11/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a severely tortuous and calcified lesion exhibiting 80% stenosis located in the ostium of the left main (lm) coronary artery. The device was inspected with no issues noted. Negative prep was performed without issue. The lesion was pre-dilated. Resistance was not encountered when advancing the device and excessive force was not used. It was reported that the stent deformed and lengthened in vivo and that the stent also dislodged after removal from the patient. The patient was reported to be alive with no injury.

 
Manufacturer Narrative

Product analysis summary: a dislodged stent was returned for analysis. The stent delivery system was not returned for analysis. Deformation and stretching was evident to the returned stent. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

An attempt was made to deploy the resolute onyx stent at the lesion at 12atm. No difficulties were noted during deployment. It was reported that after stenting, the delivery system was withdrawn and the stent also came out. 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 Key8784190
Report Number9612164-2019-02831
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRONYX40038X
Device LOT Number0009600313
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/19/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-