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

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

Patient Problems Transient Ischemic Attack (2109); Thrombosis/Thrombus (4440)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: initial experience with the next-generation resolute onyx zotarolimus-eluting stent in symptomatic intracranial ath erosclerotic disease.Ref: doi:10.3389/fneur.2020.570100 or www.Frontiersin.Org.Date of event: date of publication: 30 september 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

An article titled 'initial experience with the next-generation resolute onyx zotarolimus-eluting stent in symptomatic intracranial a therosclerotic disease' was submitted.The aim of the article was to study the safety and efficacy of a new generation of drug-eluting balloon-mounted stent (des); resolute (r) onyx des in the treatment of symptomatic intracranial atherosclerotic disease (sicad).18 patients were included in the study and were recruited using a neuroendovascular procedures database in a comprehensive stroke center.Inclusion criteria was sicad (=70% stenosis), failed medical management, and underwent intracranial stenting with r-onyx des.For the 18 patients, 19 vessels were treated and 23 resolute onyx were deployed.The vessel distal to the stenosis was catheterizedwith a microwire; in case of near occlusion of the targeted vessel, a pre-dilatation with a non medtronic balloon was performed.The r-onyx des was deployed at nominal pressure (12 atm).After deflation and withdrawal of the balloon catheter, a final digital subtraction angiography run was carried out to confirm stent deployment at the targeted stenosis and to exclude complications.In-stent thrombosis occurred in one procedure, which was resolved with intra-arterial tirofiban without complications.Tia was found in one patient at clinical follow up with no relationship to the resolute onyx the article concluded that use of r-onyx des in the treatment of sicad is safe with high technical success rates.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,gw ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,gw ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 10983244
• MDR Text Key: 220658907
• Report Number: 9612164-2020-04860
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2020
• 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: 67 YR