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

Model Number	RONYX27538UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
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
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 and was removed, on removal stent deformation was observed.The procedure was completed using a resolute onyx 2.75 x 38mm.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis summary: the 1st distal stent wrap returned positioned over the distal markerband due to stretching distal stent wraps.Deformation was evident to the 7th to 10th distal stent wraps with struts raised and stretched.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
No damage was noted to the device packaging.The device was inspected before use with no issues noted.The lesion was pre-dilated.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: 9580217
• Report Number: 9612164-2020-00194
• Device Sequence Number: 374221
• Product Code: NIQ
• UDI-Device Identifier: 00643169556959
• UDI-Public: 00643169556959
• 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): 03/27/2020

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: 10/01/2021
• Device Model Number: RONYX27538UX
• Device Catalogue Number: RONYX27538UX
• Device Lot Number: 0009950355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/22/2020; 03/25/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/13/2020; 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR