• 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 RONYX25015X
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary: two cine images were provided for review. The first image was labelled ¿before deployment¿. The image captures the patient's lad, the image confirms the reported lesion condition. The image captures a guidewire in the lesion. The 2. 50x15mm resolute onyx stent is not visible in the image provided. The second image was labelled ¿after deployment¿. The image captured what appears to be marker band for an unknown device in the lad. The reported stent migration cannot be confirmed by the images provided. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician intended to use a 2. 5x15mm resolute onyx drug eluting stent to treat a non tortuous mildly calcified lesion in the mid lad. No abnormalities were reported in relation to anatomy. A right femoral approach was used. No damage was noted to the packaging and no issues noted when removing the device from the hoop. The device was inspected and negative prep was performed with no issues. The lesion was pre-dilated. The device did not pass through a previously-deployed stent. No resistance was encountered when advancing the device and excessive force was not used during delivery. The lesion was post-dilated. It is reported that the stent moved position after deploying and removal of the delivery system. The stent was deployed at 8atm. A sufficient vacuum was pulled on the delivery system balloon to ensure complete deflation prior to removal. Movement did not occur during post-dilation activities. The lesion was not resistant. Post dilatation was done with an nc euphora 2. 5 x 8 mm. The stent did not move to an area of the artery that had a larger id that the lesion site. There was no interaction between the resolute onyx stent and accessory devices post-deployment. The current location of the deployed stent is the mid lad. Patient status is alive with no injury.
 
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 Key7211648
MDR Text Key110585484
Report Number9612164-2018-00127
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/23/2019
Device Catalogue NumberRONYX25015X
Device Lot Number0008395187
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 Received05/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-