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

Catalog Number	RONYX22534UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
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
An attempt was made to use one resolute onyx drug eluting stent to treat a highly calcified <(>&<)> highly tortuous lesion in the mid rca.There was no resistance noted while removing the device from the hoop.The device was inspected before use with no issues noted.The lesion was pre-dilated.It was reported that the device failed to cross the lesion and the hypotube kinked while attempting to cross the lesion.It was subsequently reported that another resolute onyx had a lifted strut when pulled back into the guide catheter at an acute angle.No patient injury is reported.
Additional Manufacturer Narrative
The target lesion was highly stenosed.Resistance was noted while advancing the device to the lesion.Excessive force was used.The device failed to cross the lesion.The resolute onyx that had the lifted strut got caught on the tip of the guide catheter when being pulled back out of the patient.The procedure was completed with 2 other resolute onyx stents (2.25 x 18mm onyx <(>&<)> 2.25 x 12mm onyx).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: 8256707
• Report Number: 9612164-2019-00214
• Device Sequence Number: 1960118
• Product Code: NIQ
• UDI-Device Identifier: 00643169556768
• UDI-Public: 00643169556768
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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: 04/04/2020
• Device Catalogue Number: RONYX22534UX
• Device Lot Number: 0009065813
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1