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

Catalog Number RONYX22522X

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  Malfunction  

Manufacturer Narrative

Product analysis: there were numerous kinks along the hypotube. There was a kink on the distal shaft 11. 4cm distal to the guidewire entry port. The stent was positioned on the balloon between the markerbands as per specifications. There was deformation to the 17th, 18th, 19th and 20th distal stent wraps with struts bunched and raised. There was misalignment of stent struts on the 6th and 7th distal stent wraps. There was no deformation to the distal tip. (b)(4).

Event Description

The physician intended to use a resolute onyx device, to treat a moderately tortuous rca with severe calcification and 80% stenosis. No damage was noted to the packaging. Device was inspected with no issues noted. Lesion was pre-dilated. It is reported that the device passed through a previously-deployed stent. It is reported that stent deformation occurred in vivo during positioning / advancement. Procedure was completed with another device. The physician believes that the event was due to use of the device in difficult lesion morphology/anatomy, i. E. The event was procedural related and not device related. No patient injury reported. Please note that this device resolute onyx is not marketed in the united states; however, it is similar to the united states marketed device resolute integrity. This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions.

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: 6192576
• MDR Text Key: 62913891
• Report Number: 9612164-2016-01346
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (Y/N): N
• Reporter Country Code: TU
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/21/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 12/06/2016
• Device Catalogue Number: RONYX22522X
• Device LOT Number: 0007395273
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 12/07/2014
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial