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

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

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109)

Event Date 05/15/2022

Event Type  Injury  

Event Description

A journal article was submitted for review titled: resolute onyx stent more effective than wingspan stent at preventing procedural c complications and long-term restenosis.The aim of this study was to compare the safety and efficacy of the resolute onyx drug eluting stent (des) and a non-medtronic (mdt) stent in similar patient populations.The primary outcomes were the occurrence of ischemic or hemorrhagic stroke or mortality within 72 hours of the procedure.Secondary outcomes were stroke and transient ischemic attack (tia) beyond 72 hours post-procedure and in-stent restenosis (=50% stenosis) at a 3 to 12-month angiographic follow-up.A total of 184 patients were included in the study.58 patients were treated with resolute onyx des and 126 patients were treated with the non-mdt stent.The median degree of percent stenosis before the procedure was 90% and the median residual stenosis after the procedure was 0%.Within 72 hours post-procedure in the resolute onyx des group one patient had a primary event of ischemic or hemorrhagic stroke or death.This complication was due to inadvertent wire perforation that ruptured a nearby posterior communication artery aneurysm.Beyond 72 hours, there was one additional in-hospital mortality in each group; one was due to a cardiac arrest and the other due to respiratory failure and end-stage renal disease.Among 41 angiographic and clinical follow-ups in the resolute onyx des group, none had a stroke and two had a tia.In terms of 6-month angiographic follow-ups, there was a significantly lower rate of symptomatic in-stent restenosis among the resolute onyx des group (n=1) versus 27 in the non-mdt stent group.For combined symptomatic and asymptomatic rates however, 1 of the resolute onyx des group patients experienced long-term in-stent restenosis compared the non-mdt stent group.The patient in the resolute onyx group who suffered from in-stent restenosis was treated with an angioplasty.A patient in the resolute onyx des group had a stent migration recorded on a 2-month follow-up angiogram due to a clinical tia.In longer-term outcomes (beyond 72 hours) of those treated 7 days beyond the initial event, the resolute onyx des group had two patients experiencing tias.There was notably significantly less in-stent restenosis among this group of patients in the resolute onyx des group (n=1) compared to the non mdt group.

Manufacturer Narrative

Journal article: resolute onyx stent more effective than wingspan stent at preventing procedural complications and long-term restenosis authors: ameer e.Hassan, mohammad khalil, sohum desai, wondwossen g.Tekle journal: interventional neuroradiology year: 2022 reference: doi: (b(4).Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided a2: average age a3: majority gender b3: date of publication 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.

Manufacturer Narrative

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.

Manufacturer Narrative

Correction: the patients were treated with intracranial stenting using either a resolute onyx drug eluting stent or a non mdt stent.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 ONYX 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15037409
• MDR Text Key: 296045152
• Report Number: 9612164-2022-02700
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2022

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: 07/05/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 09/09/2022; 07/05/2022
• Supplement Dates FDA Received: 09/12/2022; 11/01/2022
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic