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

Catalog Number RONYX45018UX

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Stroke/CVA (1770); Insufficient Information (4580)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Authors: joshua h.Weinberg, ahmad sweid, kalyan sajja, rawad abbas, ashlee asada, osman kozak, larami mackenzie, hana choe, michael reid gooch, nabeel herial, stavropoula tjoumakaris journal name: clinical neurology and neurosurgery year:2020 title of article: posterior circulation tandem occlusions: classification and techniques literature reference: doi.(b)(4).Clineuro.2020.106154 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 ¿posterior circulation tandem occlusions: classification and techniques¿.The study conducted a retrospective analysis of a prospectively maintained database and identified 17 patients with posterior circulation tandem occlusions who underwent mechanical thrombectomy between 2014 and 2019.A resolute onyx coronary drug eluting stent was implanted in a patient during this study.The patient which presented to the emergency department (ed) after an episode of right arm and leg weakness and confusion.Magnetic resonance imaging (mri) of the brain showed a left medial temporal lobe diffusion weighted imaging restriction and right extracranial vertebral artery (va) irregularity.The next morning the patient became comatose, hypotensive, tachycardic and hypoxic.Motor exam showed extensor posturing in all extremities.Nihss was 36.Ct angiography (cta) showed basilar artery (ba) thrombosis.The patient was taken for emergent revascularization.The right femoral artery was accessed.A non-medtronic catheter was advanced into the arch and the right subclavian artery was accessed.The right va was found to be occluded which was revascularized using a non-medtronic balloon.Proceeding angiographic runs revealed a basilar artery occlusion (bao), which was treated with aspiration thrombectomy using a non-medtronic catheter.Further angiographic runs showed bilateral posterior cerebral artery (pca) occlusions.The right pca occlusion was treated with aspiration alone, while the left pca occlusion was treated with 2 passes of a non-medtronic stent retriever and suction from non-medtronic catheter.Final angiographic run showed complete revascularization.Finally, a resolute onyx 4.5 × 18 mm drug-eluting stent was placed at the right va origin.The patient was bolused with aggrastat and plavix 300 mg prior to stent deployment.An aggrastat drip was also started but was discontinued 6h after the patient received the plavix loading dose.An mri the next day showed multiple infarcts in the pons and cerebellum.The patient received a percutaneous endoscopic gastrostomy tube and was discharged to rehabilitation with dysphagia, dysarthria, and left-sided hemiparesis.

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.

• 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: 15542264
• MDR Text Key: 301157927
• Report Number: 9612164-2022-03663
• 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: 11/08/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX45018UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 11/08/2022
• 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