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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fistula (1862); Rupture (2208); Vascular Dissection (3160)

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

Authors: timothy g white, kevin a shah, prateeka koul, thomas link, amir r dehdashti, jeffrey m katz, athos patsalides, henry h woo journal name: interventional neuroradiology year:2022 title of article: the resolute onyx drug eluting stent for neurointervention: a technical series literature reference: doi: 10.1177/15910199221084398 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 "the resolute onyx drug eluting stent for neurointervention: a technical series".The purpose of this study was to demonstrate the technical nuances and procedural safety of the resolute onyx drug eluting stent (des) for neurointerventional procedures.The primary outcome assessed was technical success of the procedure as well as any periprocedural complications.A total of 38 patients underwent stenting with a resolute onyx des as part of this study.The resolute onyx stent was used off- label in all cases.The indications for stenting included recurrent stroke due to intracranial atherosclerotic disease (icad), acute ischemic stroke with with immediate re-occlusion or the inability to re-open the target vessel, arterial dissection, vertebral origin stenosis or in-stent stenosis from another device.Lesions treated included the anterior circulation - internal carotid arteries (ica), petrous, cavernous, supraclinoidal, middle cerebral artery (mca); the external carotid; and the posterior circulation - v1, v3/4, basilar.The guide catheter used varied per procedure but was always at least 0.071in diameter.An intermediate catheter was used for all intracranial cases and the stent was deployed over a non mdt microwire.Stent size was chosen based on 80% of the proximal parent vessel diameter, while stent length was chosen based upon the shortest possible stent to cover the diseased region.During stent placement, the stent was deployed in a fashion to avoid overlap over branching vessels.Balloon inflation was not always to nominal pressure, but instead done by visualization and halted once the stent was successfully expanded to a reasonable diameter when compared to the adjacent normal parent vessel.The stent was deployed and detached from the delivery system by deflating the balloon.The procedure was a technical success in most of the cases.There was one periprocedural technical complication.A dissection occurred upon placement of the access system that subsequently led to vessel rupture when the balloon was inflated and the stent was deployed leading to a cavernous carotid fistula.The dissection was only noted on post-procedural review of the images.It was believed that the vessel dissection likely occurred during vessel access and was not due to the device itself.

• 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: 15876697
• MDR Text Key: 304423447
• Report Number: 9612164-2022-04458
• 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
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• 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: 11/02/2022
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Male