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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Stroke/CVA (1770); Occlusion (1984); Transient Ischemic Attack (2109); Stenosis (2263); Vascular Dissection (3160)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

Literature article title: endovascular therapy of subclavian artery occlusive disease involving the vertebral artery origin authors:vera schneider, ralf dirschinger, isabel wustrow, arne müller, et.Al.Journal: subclavian and vertebral artery intervention issue:3 ref: 10.1024/0301-1526/a000842.Average age, majority gender, date of publication.Patient death(s) were also included in the results of the journal article, however no causal link suggesting that the medtronic device(s) used in the patient cohort may have caused or contributed to the death(s) was provided procedural images in the article provided the basis of the analysis.The images show revascularization techniques.However, it is not known from the images if the stents pictured are endeavor resolute devices therefore the images are inconclusive for the reported adverse events.There are no other images present that offer further information on the reported adverse events.(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted.The aim of this study was to retrospectively evaluate different interventional strategies for sa (s ubclavian artery) disease in a larger cohort with a special focus on the medial segment involving the va (vertebral artery) origin.The majority of sa lesions were located in the proximal segment, some lesions were located in the medial and distal segments.Endeavor rx coronary drug eluting stent was among the devices used.An endeavor rx coronary drug-eluting stent was implanted in one patient for revascularization of the vertebral segment after predilatation of the stent struts in the sa.Of those 28 patients with medial sa lesions, the va origin had to be additionally treated in 15 patients.10 patients had a true, pr e-existing va lesion and 5 out of the remaining 18 patients without a pre-existing lesion suffered from plaque shift during sa intervention with a significant obstruction of the va ostium.Nine patients with pre-existing va stenosis were revascularized by stent im plantation using bifurcation t-stenting with stenting of the sa first, followed by va stenting in all but one patient.The median follow-up time was 12 months.Clinical outcomes included one death during index hospital stay due to a sepsis which was not attributable to the endovascular procedure.Other clinical outcomes included stroke during the intervention of a right-sided proximal subclavian, transient ischemic attack (tia), plaque-shift during medial sa intervention into the va was considered as a complication, vascular access site complications, false aneurysm, non flow-limiting dissection and restenosis.

Manufacturer Narrative

Additional information: it was confirmed that there was no causal relationship between the endeavor device and any of the adverse events (stroke, transient ischemic stroke) reported.It was also confirmed that there was no causal relationship between the endeavor device and the one death reported.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDEAVOR RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10147799
• MDR Text Key: 194943869
• Report Number: 9612164-2020-02196
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 69