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

Model Number	RONYX25022UX
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
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 attempted to be used to treat a severely tortuous, severely calcified lesion with 90% stenosis in the proximal cx artery.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was not used.It was stated that when attempting to position the device resistance was met while trying to advance around tortuosity.It was reported that stent deformation occurred in vivo during positioning.A telescope 6f guide extension catheter was also used during the procedure.It was also stated that resistance was encountered when withdrawing the device back into the telescope catheter.The telescope and the resolute onyx were removed simultaneously.No patient injury was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the resolute onyx stent delivery system (sds), returned loaded in a telescope guide extension catheter (gec).The ronyx sds loaded in the telescope gec could not be removed by pulling the sds proximally due to the deformed stent struts, therefore the proximal shaft of the device was cut and the ronyx sds was pulled distally to separate the devices.The stent was positioned on the balloon but not between the marker-bands as deformation to the distal stent struts resulted to the stent stretching over the distal marker-band.Deformation was evident from the 1st to the 4th, as well as the 12th distal stent wraps with struts raised and overlapping.No deformation was evident to the distal tip.No other damage evident to the remainder of the device.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 tortuous, severely calcified lesion with 90% stenosis in the proximal cx artery.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was not used.It was stated that when attempting to position the device resistance was met while trying to advance around tortuosity.It was reported that stent deformation occurred in vivo during positioning.A telescope 6f guide extension catheter was also used during the procedure.It was also stated that resistance was encountered when withdrawing the device back into the telescope catheter.The telescope and the resolute onyx were removed simultaneously.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: 9488831
• Report Number: 9612164-2019-05221
• Device Sequence Number: 16469946
• Product Code: NIQ
• UDI-Device Identifier: 00643169556829
• UDI-Public: 00643169556829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 03/04/2020

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: 04/29/2021
• Device Model Number: RONYX25022UX
• Device Catalogue Number: RONYX25022UX
• Device Lot Number: 0009703048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/20/2020; 03/03/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/13/2020; 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1