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

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).

• Brand Name: ENDEAVOR RX
• Type of Device: CORONARY 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 Key: 12056118
• MDR Text Key: 258005570
• Report Number: 9612164-2021-02450
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2021

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: 06/15/2021
• Initial Date FDA Received: 06/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR