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

Model Number	RONYX27508UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stent was positioned on the balloon between the marker bands as per specifications.Misalignment of stent struts was evident to the 1st distal stent wraps.No deformation was evident to the distal tip.No other damage was evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
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 attempted to be used to treat a severely calcified lesion in the circumflex artery.Negative prep was not performed.The lesion was not pre-dilated.Resistance was encountered when advancing the device due to calcium.Multiple attempts were made to try to get the device to advance.It was stated that stent deformation occurred in vivo during positioning.It was also stated that the device was removed after a failed delivery, the device was attempted to be re-loaded on the wire when deformed struts were noticed.The lesion was then predilated with a euphora balloon catheter and an non medtronic stent was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: the device was inspected prior to use, but unknown if damaged prior to being inserted over wire into guide.Excessive force was used back and forth to try to get the stent to advance.The device did not pass through a previously deployed stent.It was reported the patient is alive.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 9473823
• Report Number: 9612164-2019-05191
• Device Sequence Number: 11488805
• Product Code: NIQ
• UDI-Device Identifier: 00643169556874
• UDI-Public: 00643169556874
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup,Followup
• Report Date (Section B): 02/25/2020

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: 07/17/2021
• Device Model Number: RONYX27508UX
• Device Catalogue Number: RONYX27508UX
• Device Lot Number: 0009836118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 01/13/2020; 02/24/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 12/18/2019; 02/10/2020; 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR