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

Catalog Number	RONYX40022UX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
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 intended to be used to treat a moderately calcified, severely tortuous lesion.The device was inspected with no issues noted.Negative prep was performed without issue.The device was not kinked and re straightened.It was reported that while loading the stent on the wire into a 5.5 guide liner the reslolute onyx device wouldn¿t go into the guide liner and on removal of the onyx device from the body, it was noticed that the stent had moved back off of the balloon.It is also indicated that a device detachment occurred during advancement through the guide catheter.The patient is alive with no injury.
Additional Manufacturer Narrative
Device evaluation summary: kinks were evident on the hypotube.The stent was not positioned on the balloon between the marker bands as per specifications.The stent had moved proximally on the balloon.Deformation was evident to the 18th distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.There was 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
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: 8991191
• Report Number: 9612164-2019-03869
• Device Sequence Number: 11595787
• Product Code: NIQ
• UDI-Device Identifier: 00643169557185
• UDI-Public: 00643169557185
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/08/2019

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: 09/04/2020
• Device Catalogue Number: RONYX40022UX
• Device Lot Number: 0009311625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/03/2019; 10/31/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/30/2019; 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1