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

Catalog Number	RONYX35008UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2018
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 one resolute onyx rx coronary drug eluting stent to treat lesion.It was reported that the stent failed to cross the lesion and stent deformation occurred.It is indicated that stent deformation occurred due to calcification of the tortuous vessel.The procedure was completed using a non-mdt stent.No patient injury is reported.
Additional Manufacturer Narrative
An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a heavily calcified non tortuous mid lad lesion exhibiting 90% stenosis.It is indicated that stent deformation occurred due to stent getting caught on the calcification of the vessel.The account reported that the event was related to a sizing issue.The procedure was completed using a smaller non-medtronic stent after further pre-dilation.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: 8073098
• Report Number: 9612164-2018-03215
• Device Sequence Number: 1721663
• Product Code: NIQ
• UDI-Device Identifier: 00643169557055
• UDI-Public: 00643169557055
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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: 03/29/2019
• Device Catalogue Number: RONYX35008UX
• Device Lot Number: 0008556999
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1