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

Model Number RONYX30012UX

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Mechanical Jam (2983)

Patient Problem Stenosis (2263)

Event Date 11/19/2018

Event Type  Injury  

Event Description

During cardiac catheterization following stemi involving right coronary artery (rca), a 3.0 x 12mm medtronic resolute onyx stent was employed.While attempting to navigate a very tortuous midportion of the rca, the stent itself became stuck and stripped off of its balloon deployment system.The stent was not able to be brought back but could be moved downstream.The stent was maneuvered into the distal right posterior descending coronary artery.The right coronary artery was re-imaged.It was confirmed that the vessel was not disrupted and that timi 3 flow had been achieved.There was a 30% residual stenosis post intervention.Aspirin and plavix were recommended as lifelong medications.

• Brand Name: MEDTRONIC RESOLUTE ONYX STENT
• Type of Device: CORONARY DRUG - ELUTING STENT
• Manufacturer (Section D): MEDTRONIC VASCULAR; santa rosa CA
• MDR Report Key: 8331549
• MDR Text Key: 136010301
• Report Number: MW5083895
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556973
• UDI-Public: 00643169556973
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2020
• Device Model Number: RONYX30012UX
• Device Lot Number: 0009222046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 101