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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR RX CORONARY DRUG-ELUTING STENT

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MEDTRONIC IRELAND ENDEAVOR RX CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Ischemia (1942); Transient Ischemic Attack (2109)
Event Date 07/06/2020
Event Type  Injury  
Manufacturer Narrative
Journal article: validation and comparison of drug eluting stent to bare metal stent for restenosis rates following vertebral artery ostium stenting: a single-center real-world study authors: long li, xu wang, bin yang, yabing wang, peng gao, yanfei chen, fengshui zhu, yan ma, haitao chi, xiao zhang, xuesong bai, yao feng , adam a dmytriw, tao hong, yang hua, liqun jiao and feng ling journal: interventional neuroradiology year: 2020 reference: doi: 10. 1177/1591019920949371. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article titled - validation and comparison of drug eluting stent to bare metal stent for restenosis rates following vertebral artery ostium stenting: a single-center real-world study - was submitted for review. This study sought to compare in-stent restenosis (isr) rates of drug-eluting stents (des) and bare metal stent (bms) in the treatment of vertebral artery ostium (vao) stenosis. Over a 1. 5 year period, 137 consecutive patients underwent vao stenting with 76 of these patients receiving a des and 74 receiving a bms. The medtronic endeavor rx coronary des was among the des used in this study. To measure for isr, all the patients underwent mri before and 3 days after procedure. Additionally, carotid and vertebral artery doppler ultrasonography (dus) was arranged before discharge. Post-procedural mri showed that new infarctions of ipsilateral vertebrobasilar territory occurred in 5 des patients. One des patient developed pulmonary infection post procedure. All patients underwent further clinical and dus follow-up for at least 6 months. During the follow up, isr occurred in 14 cases among the des group. Among all the isr patients, posterior circulation ischemic events recurred in 4 cases during the follow up, leading to a transient ischaemic attack (tia). The 4 patients were subsequently managed with either a prolongation of dual antiplatelet therapy, drug-coated balloon angioplasty or ordinary balloon angioplasty. The results showed that the use of des was associated with significant lower isr rates compared with bms in the treatment of vao stenosis. The use of the endeavor rx device for vao stenting is outside the intended use of the device and is therefore an off-label use. The ifu states the endeavor drug-eluting coronary stent system is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (ptca).
 
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Brand NameENDEAVOR RX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12056118
MDR Text Key258005570
Report Number9612164-2021-02450
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P060033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/24/2021 Patient Sequence Number: 1
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