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

Catalog Number RONYX35034X

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

Patient Problems Aneurysm (1708); Obstruction/Occlusion (2422)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Title: percutaneous coronary intervention in coronary artery aneurysms; technical aspects.Report of case series and literature review year: 2020.Reference: doi.Org/10.1016/j.Carrev.2020.12.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled; percutaneous coronary intervention in coronary artery aneurysms; technical aspects.Report of case series and literature review was submitted for review.This case reports that a patient presented with an inferior stemi.Coronary angiography via right radial access route showed an acute occlusion in the rca.The coronary artery aneurysms (caa) became apparent only following wiring the vessel.Covered stent with an appropriate size was not immediately available in the catheterisation laboratory, therefore pci was attempted with a 2.5 × 12 mm semicompliant balloon and a 3.5 × 34 mm resolute onyx drug eluting stent (des).The second aneurysm became apparent after stent deployment.It was this second aneurysm which was occluded.A 3.5 × 38 mm resolute onyx stent was deployed overlapping the first stent.It was then decided to line the stents with a covered stent.Upon trying to advance the covered stent, the guide catheter and the wire position were lost.The guide catheter was switched from jr4 to ar1 and the vessel was rewired.When advancing the guide liner extension catheter the proximal stent was displaced forward inside the large aneurysm and buckled.Thereafter it was not possible to advance a balloon or other devices through the angled stent.Given the low likelihood of success and potentially life-threatening complications, the procedure was abandoned, and medical therapy was suggested.The patient remained stable and was discharged home a few days later with combination of medications.The patient was followed up in the outpatient clinic after two months' time and reported no cardiovascular symptoms.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13051094
• MDR Text Key: 282552204
• Report Number: 9612164-2021-04941
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RONYX35034X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• 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: 84 YR
• Patient Sex: Female