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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 12/28/2023

Event Type  Injury  

Manufacturer Narrative

Journal article: single-center outcomes of onyx frontier¿ and resolute onyx¿ drug-eluting balloon-mounted stents for rescue stenting for acute large vessel occlusion journal: interventional neuroradiology year: 2024 ref: doi: 10.1177/15910199231226285 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.

Event Description

A journal article was submitted for review titled "single-center outcomes of onyx frontier¿ and resolute onyx¿ drug-eluting balloon- mounted stents for rescue stenting for acute large vessel occlusion".This study aims to present the initial experience of a single institution regarding the utilization of onyx frontier and resolute onyx zotarolimus-eluting stents for rescue stenting following failed mechanical thrombectomy (mt).A comprehensive retrospective chart review was performed of all patients who underwent rescue stenting, in the setting of failed mt for occlusive lesions and residual intracranial atherosclerotic disease (icad) after clot removal, using onyx frontier¿ or resolute onyx¿ stents.A total of 18 patients were treated with 22 onyx frontier or resolute onyx stents for rescue stenting in the setting of failed mt.Of these, 13/18 (72.2%) cases used resolute onyx stents whereas 5/18 (27.8%) cases used onyx frontier stents.Stent locations were distributed as follows: 36.4% in the middle cerebral artery (mca), 18.2% in the internal carotid artery (ica), 22.7% in the vertebral artery (va), and 22.7% in the basilar artery (ba).The most used stent length was 12mm, with stent diameters of 2mm or 3mm being the most frequently chosen.When rescue stenting was performed, the intermediate or aspiration catheter was exchanged for a 5f non-medtronic (mdt) intermediate catheter; although, in select cases, the aspiration catheter remained unchanged.Prior to stent deployment, a dyna cone-beam computed tomography (ct) was performed to evaluate the presence of intracranial hemorrhage (ich).To facilitate navigation of the stent, the intermediate catheter was advanced beyond the origin of the ophthalmic artery.The stent diameter was usually selected to be approximately 0.25mm smaller than the proximal vessel diameter to minimize the risk of oversizing.Stenting was accomplished by initially passing the stenotic lesion with a microcatheter and subsequently introducing an exchange-length non-mdt support microwire to remove the microcatheter and load the stent system.The balloon-mounted stent was navigated to the lesion and inflated to the appropriate diameter at 6 to 10 atm (sub-nominal).The system was then removed after visual confirmation that the stent had been completely deployed.Following the procedure, a micro-dyna ct was performed to ensure adequate stent expansion and vessel patency.Thrombolysis in cerebral infarction (tici) 3 was achieved in 43.8% of patients, tici 2c in 43.8% of patients, and tici 2b in 12.5% of patients.No pre or post stenting angioplasty was necessary for any device, and there were no difficulties in positioning or delivering the device.Only 6 patients received moderate-to-long interval follow-up imaging, which was done at 1¿9 months following stent placement.Of those six patients who received imaging, five had patent stents and only one showed moderate stenosis.One patient received a short-interval magnetic resonance angiogram 2 weeks after stent placement showing occlusion, which is the only occlusion case in this series.Ich occurred in 3/18 of patients, but only one patient experienced symptomatic ich (pancisternal subarachnoid haemorrhage), attributed to a technical complication of vessel rupture, which required hemicraniectomy.This was the only technical/procedural complication observed, which occurred due to stent oversizing.A 3.5x12mm resolute onyx stent was used.Among the asymptomatic hemorrhages, one was a right basal ganglia ich in a case where the right m1 was stented (2.0x8mm resolute onyx), and the other was a right temporo-occipital ich in a case where the ba was stented (3.0x22mm resolute onyx).Therefore, both hemorrhages could be attributed to reperfusion and/or distal hemorrhagic transformation from thrombolysis and anti-platelets.The two patients with asymptomatic hemorrhage (both small intraparenchymal hemorrhage (iph)), all received aspirin (81 mg or 325 mg) followed by a cangrelor drip, which was later transitioned to clopidogrel or ticagrelor.No post-stenting deaths were reported.

Manufacturer Narrative

Annex d codes.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: STENT, CORONARY, DRUG-ELUTING
• 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: 18836474
• MDR Text Key: 336887159
• Report Number: 9612164-2024-01087
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• 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; Other
• Patient Age: 63 YR
• Patient Sex: Male