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U.S. Department of Health and Human Services

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

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MEDTRONIC ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT Back to Search Results
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.

 
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Brand NameENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT
Type of DeviceCORONARY STENT
Manufacturer (Section D)
MEDTRONIC
MDR Report Key5949092
MDR Text Key54791785
Report NumberMW5064727
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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 Received09/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number2.5MM X 8MM
Device Catalogue NumberENSP25008UX
Device LOT Number0005957579
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/09/2016 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
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