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

Catalog Number	RONYX27534UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use two resolute onyx rx drug eluting stents (the first device is ronyx27534ux and the second device ronyx27538ux) to treat a lesion.There were no abnormalities reported in relation to anatomy.There was no damage noted to devices packaging.There were no issues noted when removing the devices from the hoop/tray.Negative prep was performed on the devices with no issues identified.It was reported that stent deformation occurred in-vivo during positioning.In each case the devices were replaced by a resolute onyx of the same size.No patient injury was reported.

• 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: 7125893
• Report Number: 9612164-2017-01995
• Device Sequence Number: 13742905
• Product Code: NIQ
• UDI-Device Identifier: 00643169556942
• UDI-Public: 00643169556942
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

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: 07/19/2019
• Device Catalogue Number: RONYX27534UX
• Device Lot Number: 0008711181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1