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

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.

• Brand Name: RESOLUTE ONYX¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 7913684
• MDR Text Key: 121867771
• Report Number: 7913684
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX27518UX
• Device Catalogue Number: RONYX27518UX
• Device Lot Number: 008974621
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Weight: 95