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

Catalog Number	RONYX40026UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
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 moderately tortuous and severely calcified lesion.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.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.Excessive force was not used during delivery, it was reported that stent deformation occurred in-vivo during positioning.It was described that the physician tried a number of times to place the stent in a highly calcified area and during this time one of the stent struts lifted.It was also reported that the physician then pre dilated the lesion again and completed the procedure using a non-medtronic stent.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 1st, 2nd and 15th stent wraps, with struts raised.Deformation was evident to the distal tip, with tip appearing uneven.The guidewire lumen patency was verified with a 0.015 inch mandrel.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: 7320563
• Report Number: 9612164-2018-00466
• Device Sequence Number: 10793012
• Product Code: NIQ
• UDI-Device Identifier: 00643169557192
• UDI-Public: 00643169557192
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/28/2018

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: 10/25/2019
• Device Catalogue Number: RONYX40026UX
• Device Lot Number: 0008848030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 03/29/2018; 05/11/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/25/2018; 05/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1