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

Catalog Number	RONYX35030UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
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
A resolute onyx drug eluting stent was intended to be used to treat a severely tortuous, mildly calcified lesion with 80% stenosis in the ostium of the left main coronary artery.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was used.It is reported that stent deformation occurred in vivo during positioning.The physician was positioning the onyx from the proximal lcx to the ostial left main.The lcx takeoff was a 140 degree bend followed by a 90 degree bend.While attempting to position the stent the proximal edge of the stent was lifted up by the tip of the guide catheter.The procedure was completed using another 3.5x30mm onyx device.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis: kinking was evident along the hypotube during analysis.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 29th and 30th stent wraps, with struts raised, bunched and overlapping.Deformation was evident to the distal tip, with tip appearing torn.The guidewire lumen patency was verified with a 0.015 inch mandrel.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: 7295576
• Report Number: 9612164-2018-00407
• Device Sequence Number: 1671250
• Product Code: NIQ
• UDI-Device Identifier: 00643169557116
• UDI-Public: 00643169557116
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 04/25/2018

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: 09/22/2019
• Device Catalogue Number: RONYX35030UX
• Device Lot Number: 0008807550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 82