MAUDE Adverse Event Report: MEDTRONIC ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT

Model Number 2.5MM X 8MM

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Discomfort (2330)

Event Date 04/17/2013

Event Type  Injury  

Event Description

(b)(6) placed a medtronic zotarolimus eluting coronary stent endeavor in an 80% blockage of a large branch of left anterior descending artery on (b)(6) 2013.In mid (b)(6) i began having headaches.They developed over a few weeks to being nearly constant.(previously i might have 2 headaches a year.) they were mild to start the day and would grow to moderate by midday every day.In (b)(6) 2013, a brain mri was done by breast cancer oncologist.This got me a consult with a neurologist.She disagreed about the mri results and proceeded to treat the chronic daily headache (cdh) with prescriptions and intravenous injections, which only added to my discomfort.Nothing alleviated the ongoing headaches.In (b)(6) 2014, they diminished and we were gone completely by (b)(6).It was (b)(6) 2014 when i suggested my hypothesis of a correlation between the stent and the cdh to a (b)(6) pharmacist.He confirmed that a side effect of zotarolimus was headaches.All of my doctors were informed of my headaches and knew of my stent but i ended up putting 2 and 2 together a year and a half later.I don't want this to happen to anyone else.

• Brand Name: ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT
• Type of Device: CORONARY STENT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5949092
• MDR Text Key: 54791785
• Report Number: MW5064727
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2.5MM X 8MM
• Device Catalogue Number: ENSP25008UX
• Device Lot Number: 0005957579
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN PRN; AMBIEN 5-10MG PRN; ASPIRIN 81MG/DAY; DUCOLAX PRN; IBUPROFEN PRN; METOPROLOL 12.5 MG 2 X DAY; MIRALAX DAILY; MULTI VITAMIN DAILY; ULTRAM 50-100 PRN
• Patient Outcome(s): Other; Disability
• Patient Age: 62 YR
• Patient Weight: 82