MAUDE Adverse Event Report: MEDTRONIC VASCULAR RESOLUTE ONYX; CORONARY DRUG-ELUTING STENT

Lot Number 0009778584

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Fatigue (1849); Headache (1880); Transient Ischemic Attack (2109); Dizziness (2194); Dysphasia (2195); Embolism/Embolus (4438)

Event Date 09/10/2020

Event Type  Injury  

Event Description

After being granted medicaid, my mother's neurologist choose to switch her from her medication, brillinta to another medication.He did not give reasoning.After one month of the medication, my family and i noticed she was more tired and had difficulty saying words as she would say "forcing her words".This became so bad, that i left work and took my mother to the er to get her seen about.She had began complaining of a headache and dizziness.Upon arrival the medical team contacted the neuro on call who order a mri and then started her on triple the medication to help elevate the symptoms.They informed my mother and i that she had experience what he called "tias" and she would need further attention overnight.That morning we were told her stint "resolute onyx", lot number 0009778584.After the surgery the neurosurgeon explained the drug eluting stent failed to prevent clotting and had caused a nearly complete blockage of the artery put her at risk of another severe stroke.The neurosurgeon returned her to the original medication as well as continued quarterly monitoring.Fda safety report id# (b)(4).

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 15130036
• MDR Text Key: 296987085
• Report Number: MW5111172
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/11/2021
• Device Lot Number: 0009778584
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN ; BRILINTA; DIAZEPAM ; LEXAPRO
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American