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

Catalog Number	RONYX20022UX
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
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
An attempt was made to use two resolute onyx rx coronary drug eluting stents to treat a lesion located in the obtuse marginal (om).Both devices were inspected with no issues.It was reported that while attempting to use the 2.00x22mm resolute onyx stent, there were inflation difficulties and that the device was unable to cross the lesion and stent deformation occurred with struts of the stent protruding from the balloon catheter.It was also reported that the 2.25x15 mm resolute onyx stent could not cross the lesion and stent deformation occurred with struts of the stent protruding from the balloon catheter.No patient injury reported.
Additional Manufacturer Narrative
It was reported that while attempting to use the 2.00x22mm resolute onyx stent the device was unable to cross the lesion and stent deformation occurred with struts of the stent protruding from the balloon catheter.The device was never inflated.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: 8227009
• Report Number: 9612164-2019-00107
• Device Sequence Number: 13970606
• Product Code: NIQ
• UDI-Device Identifier: 00643169556669
• UDI-Public: 00643169556669
• 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,Followup
• Report Date (Section B): 03/08/2019

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: 12/19/2019
• Device Catalogue Number: RONYX20022UX
• Device Lot Number: 0008928837
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1