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

Catalog Number	RONYX22530UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
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
It was reported that the physician intended to use a resolute onyx drug eluting stent to treat a lesion located at the distal right coronary artery which had moderate tortuosity and mild calcification.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.The lesion was pre-dilated.Resistance was encountered when advancing the device and excessive force was not used during delivery.It was reported that the stent deformation occurred in-vivo during positioning/advancement.It was reported that the stent struts were damaged.It was informed that the physician complete the procedure using a 2.5x18 non-medtronic device.No patient injuries were reported.
Additional Manufacturer Narrative
Evaluation summary: protective sheath and stylette were returned with device.Numerous kinks were evident along the hypotube.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 11-14th and 22nd stent wraps, with struts raised and bunched.No deformation was evident to the distal tip.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: 7279649
• Report Number: 9612164-2018-00370
• Device Sequence Number: 1066502
• Product Code: NIQ
• UDI-Device Identifier: 00643169556751
• UDI-Public: 00643169556751
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/25/2018

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: 03/07/2019
• Device Catalogue Number: RONYX22530UX
• Device Lot Number: 0008524028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1