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

Model Number	RONYX35015UX
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the device was inspected before use with no issues reported.Device evaluation summary: the stent had moved proximally on the balloon and was not positioned on the balloon between the marker bands as per specifications.Crimp impression were visible on the exposed balloon surface.The balloon folds were expanded.Deformation was evident to the entire stent with struts raised and stretched.Deformation was evident to the distal tip.Kinks were evident to both hypotube and distal shaft.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 a resolute onyx rx coronary drug eluting stent.It was reported that the stent did not deploy, the stent got pushed back proximal to the balloon on the shaft of the delivery system.No patient injury was reported.
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: 9254946
• Report Number: 9612164-2019-04543
• Device Sequence Number: 16614169
• Product Code: NIQ
• UDI-Device Identifier: 00643169557079
• UDI-Public: 00643169557079
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/21/2020

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: 11/19/2020
• Device Model Number: RONYX35015UX
• Device Catalogue Number: RONYX35015UX
• Device Lot Number: 0009447967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 11/25/2019; 01/17/2020
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 12/09/2019; 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1