• 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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Thrombus (2101)
Event Date 04/14/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the procedure, one resolute onyx drug eluting stent was used to treat a mildly tortuous and calcified lesion, located in the distal right coronary artery, exhibiting 80% stenosis.There were no abnormalities in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.No issues noted during stent deployment and the resolute onyx was post dilated.Patient had atrial fibrillation (af) at the time of the initial procedure before the lesion was post dilated.It was reported that the patient returned to hospital approximately one month after the initial procedure complaining of chest pain.Cardiac catheterisation was performed.Thrombus was discovered in the very distal portion of the stent.Thrombus was aspirated using a medtronic catheter (export).The patient had af before and after use of the export catheter.The stent was post dilated again.Patient was not on aspirin at time of thrombosis.Patient is not on aspirin and full dosage of eliquis.Patient status is alive with no injury.
 
Manufacturer Narrative
Cine image review: the images capture thrombus located in the distal rca, in the distal portion of the resolute onyx stent, and in the previously deployed unknown brand stent.The outline of previously deployed stents are visible in the vessel.A medtronic export catheter is used to treat the thrombus.An unidentified balloon is used to post dilate the stent at the site of the thrombus.Post-dilation is continued throughout the proximal rca.The next images capture the blood flow restored throughout the rca, with no evidence of a thrombus.If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RESOLUTE ONYX RX
Type of Device
STENT, 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 Key7532544
MDR Text Key108850852
Report Number9612164-2018-01182
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/26/2018
Initial Date FDA Received05/22/2018
Supplement Dates Manufacturer Received08/15/2018
Supplement Dates FDA Received09/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age79 YR
-
-