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

Model Number	RONYX20026UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
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
During the procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a lesion located in the mid obtuse marginal (om).There were no abnormalities in relation to the anatomy.There was no damage noted to packaging.There were no issues noted when removing device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre dilated.It was reported that the device failed to cross the lesion and stent deformation occurred in vivo during positioning.The procedure was completed using a balloon.No patient injury reported.
Additional Manufacturer Narrative
The lesion was calcified.Resistance was encountered when advancing the device.Patient is alive without injury.Product was disposed of at the account.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: 7896934
• Report Number: 9612164-2018-02465
• Device Sequence Number: 168330
• Product Code: NIQ
• UDI-Device Identifier: 00643169556676
• UDI-Public: 00643169556676
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/28/2019

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: 04/08/2020
• Device Model Number: RONYX20026UX
• Device Lot Number: 0009073231
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/03/2018; 01/25/2019
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/25/2018; 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1