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

Catalog Number	RONYX27530UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A resolute onyx rx coronary drug eluting stent was intended to be used during a procedure to treat a lesion in the right coronary artery.The lesion was predilated.The device could not cross the lesion, it was removed and a buddy wire system was attempted but the device would still not cross.The lesion was predilated a second time using a non compliant balloon however the device still could not cross.It was reported that when the device was removed the stent strut was damaged.The procedure was complete using two 2.75 x 15 mm resolute onyx stents.The patient is alive with no injury.
Additional Manufacturer Narrative
Device evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 21st distal stent wrap with struts raised.No deformation was evident to the distal tip.The inner lumen patency could not be verified with a 0.015 inch mandrel most likely due to harden blood in the guidewire lumen.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8835497
• Report Number: 9612164-2019-03076
• Device Sequence Number: 2534593
• Product Code: NIQ
• UDI-Device Identifier: 00643169556935
• UDI-Public: 00643169556935
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2020
• Device Catalogue Number: RONYX27530UX
• Device Lot Number: 0009045084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1