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

Catalog Number UNK-CV-GWY-RONYX

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 10/28/2018

Event Type  Injury  

Manufacturer Narrative

Lit ref: doi:10.11909/j.Issn.1671-5411.2018.10.001.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient presented to the emergency department with severe chest pain within 2 hours after onset of symptoms.The electrocardiogram (ecg) showed newly diagnosed af and st-segment elevation in the anterior leads.The patient had undergone elective pci in using resolute onyx drug eluting stents in the proximal left anterior descending (lad), 2.75 × 22 mm; post-dilated with a non-compliant (nc) 3.0 × 12 mm balloon at 16 atm] and in the right coronary artery (rca) (5.0 × 26 mm proximally post-dilated with a 5.0 nc balloon; 3.0 × 26 mm and 2.75 × 18 mm distally post-dilated with 3.0 × 15 mm nc balloon at 14 atm 16 months prior to admission.Dapt consisting of 75 mg aspirin and 75 mg clopidogrel was prescribed for an intended period of 12 months following pci.Transradial cardiac catheterization revealed a thrombotic occlusion at the site of the stent implanted in the proximal lad with thrombolysis in myocardial infarction (timi) 0 flow and a thrombus at the site of the proximal stent in the mid rca with timi 2 flow and a moderate to severe focal lesion just before the 3.0 × 26 mm stent.Following oral administration of 300 mg of aspirin and 180 mg of ticagrelor loading doses and 9000 u of unfractionated heparin through the radial sheath, primary pci was performed in the blocked lad which was felt the culprit lesion of this presentation.Thrombus aspiration was then performed with an export catheter restoring timi 3 flow in the lad.There was evidence of some remaining thrombus in the lad stent, which was clearly undersized in angiography.Predilation of the lad stent was performed with a semi-compliant sprinter balloon and a non-medtronic balloon.Two non-medtronic stents were deployed with a good final angiographic result and resolution of the anterior st elevation ecg changes.Intravascular ultrasound (ivus) study was performed which confirmed good stent apposition and expansion.The procedure was covered with tirofiban bolus and 12 hour intravenous infusion post-pci due to the significant amount of thrombus found on both lad and rca.A coronary angiogram demonstrated complete resolution of the rca thrombus.An ivus study confirmed an eccentric plaque before the mid rca stents with stent undersizing, and severe malapposition throughout the entire length of the rca stents.A non-medtronic balloon was used to post-dilate the undersized stent and a non-medtronic balloon 3.5 × 20 mm for the malapposed part and finally implanted a 4.0 × 22 mm non-medtronic stent post-dilated with a 4.0 nc at 16 atm of pressure to cover the lesion just before the previous mid rca stents, giving an excellent final angiographic and ivus result.The patient was discharged on aspirin 75mg od for 1 month, ticagrelor 90 mg b.D.For 12 months and rivaroxaban 15 mg o.D.Lifelong.It was noted that the mechanisms of very late stent thrombosis in this case most likely were a combination of mechanical factors (severe stent undersizing and malapposition during the index procedure) and systemic factors (atrial fibrillation).

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8160845
• MDR Text Key: 130236229
• Report Number: 9612164-2018-03612
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-RONYX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2019
• 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: 80 YR