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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. RESOLUTE ONYX¿ CORONARY DRUG-ELUTING STENT

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MEDTRONIC, INC. RESOLUTE ONYX¿ CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number RONYX27518UX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Weakness (2145); Dizziness (2194)
Event Date 09/18/2018
Event Type  malfunction  
Event Description
The pt. Presented with weakness, lightheadedness and shortness of breath (sob). Came to hospital via ems. Cardiac workup showed stemi. Pre-procedural work-up showed no known allergies both in her ehr and in questioning the patient who was alert and oriented. Pt. Taken to cath. Lab and received two drug eluting stents for a blockage in her mid and distal right coronary artery (rca). Pt. Was admitted and recovered from the procedure without incident. The next morning, mid-(b)(6), the rn was assessing the patient and the patient stated she had an allergy to nickel which she stated "goes systemic". Rn notified her physician and investigation into the stent content revealed this device does contain nickel and a precaution is stated in the literature to that effect. Manufacturer response for coronary stent, resolute onyx¿ zotarolimus-eluting coronary stent system (per site reporter). See previous comments on first device information. Manufacturer response for coronary stent, resolute onyz zotarolimus-eluting coronary stent (per site reporter). Assisted in investigation of the stents metal content. Supplied literature describing the device and completed an incident report for their company.
 
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Brand NameRESOLUTE ONYX¿
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic parkway
minneapolis MN 55432
MDR Report Key7913684
MDR Text Key121867771
Report Number7913684
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRONYX27518UX
Device Catalogue NumberRONYX27518UX
Device Lot Number008974621
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/21/2018
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer09/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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