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

Catalog Number	RONYX22522UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
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
During a procedure a resolute onyx rx coronary drug eluting stent was used to treat a lesion in the first diagonal.The lesion was predilated.It was reported that the device could not cross the lesion and that a strut was noted to be lifted.The procedure was completed using a non medtronic device.The patient is reported as alive with no injury.
Additional Manufacturer Narrative
Device evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 9th 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.A resolute onyx 2.25mm*15mm was received with the complaint device.There is no complaint against the device with lot number 0009047969.There was no damage noted to this device.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: 8704031
• Report Number: 9612164-2019-02378
• Device Sequence Number: 2386414
• Product Code: NIQ
• UDI-Device Identifier: 00643169556737
• UDI-Public: 00643169556737
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 03/31/2020
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0009056586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1