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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number UNK-CV-GWY-RONYX
Device Problems Inadequacy of Device Shape and/or Size; Malposition of device
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 malposition 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 malposed 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.

 
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Brand NameRESOLUTE ONYX RX
Type of DeviceSTENT, 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 Key8161098
Report Number9612164-2018-03614
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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 Received12/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK-CV-GWY-RONYX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/13/2018 Patient Sequence Number: 1
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