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

Device Problem Insufficient Information (3190)

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 03/07/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: efficacy of zotarolimus-eluting stents in treating diabetic coronary lesions: an optical coherance tomography study authors: zhengbin zhu, jinzhou zhu, run du, haotian zhang, jinwei nid journal: advances in therapy year: 2020 ref: doi.Org/10.6084/m9.Figshare.11871414.Majority gender,: average age, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

This study was a single-center subgroup data analysis of the resolute (b)(6) study.The study using optical coherence tomography (oct) aimed to compare target lesion neointima in patients with or without diabetes after zotarolimus-eluting stent (zes) treatment.Oct images of 90,212 struts and quantitative coronary angiography (qca) in 62 patients (32 with dm and 30 without dm) with 69 de novo coronary lesions (34 dm and 35 non-dm) both after zes implantation and at 12 month angiographic follow-up were recorded.Resolute zotarolimus-eluting stents were implanted in all patients enrolled in this study.All patients enrolled took aspirin and clopidogrel after stenting and received monthly clinical follow-up.Clinical outcomes included tlr and non-fatal myocardial infarction.It was reported that neointimal proliferation and neovascularization were more frequently observed in patients with dm than patients without dm.There was no significant difference in late lumen loss between the two groups.Uncovered struts,malapposition, and thrombus were also reported in both groups, at similar rates and the rates were noted to be quite low in both groups.It was stated that the intrastent microthrombus occurrence rate observed by oct was also similar between both groups and no clinical st (stent thrombosis) events were observed.It was also mentioned in relation to another study that a ¿¿catch-up¿¿ phenomenon had been reported which showed that the superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up with respect to occurrence of st was lost after 5 years.

Manufacturer Narrative

A4: is the average weight, not age as previously 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 10886221
• MDR Text Key: 217723977
• Report Number: 9612164-2020-04563
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 70