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

Model Number	RONYX40015UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the device was inspected before use with no issues noted.The lesion was pre-dilated.No resistance was noted while advancing the device to the lesion.Product analysis: the stent was positioned between the markerbands but not meeting specifications due to deformation of the proximal wraps.Deformation was evident to the 15th distal stent wraps with struts raised.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
During a procedure an attempt was made to use one resolute onyx rx coronary des to treat a lesion.It was reported that the device failed to cross the lesion, the device was removed from the patient and stent deformation was noticed which occurred during the initial attempt to cross the lesion.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: 9543805
• Report Number: 9612164-2020-00054
• Device Sequence Number: 2282710
• Product Code: NIQ
• UDI-Device Identifier: 00643169557161
• UDI-Public: 00643169557161
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 02/26/2020

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: 07/09/2021
• Device Model Number: RONYX40015UX
• Device Catalogue Number: RONYX40015UX
• Device Lot Number: 0009822703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/17/2020; 02/24/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/11/2020; 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1