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

Catalog Number	RONYX35008UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 and overlapping.Deformation was evident to the distal tip.The inner lumen patency was verified.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a resolute onyx rx coronary drug eluting stent to treat a moderately tortuous and moderately calcified lesion located in the distal right coronary artery exhibiting 80% stenosis.There was no damage noted to packaging and there were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.Negative prep was not performed.The device did pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was used during delivery.It was reported that the first stent to be used, a 3.5x38mm resolute onyx rx stent, was deployed in a de novo lesion in mid/distal rca.Post first stent placement, there was a perceived edge dissection.A 3.5x8mm resolute onyx stent was then advanced through the existing stent in an attempt to treat the perceived dissection.During the advancement resistance was noted and more force than usual was exerted to attempt to pass the stent through the existing stent.It was reported that when the stent was withdrawn, deformation of the stent struts was noted.A balloon was passed through the stent to dilate the perceived dissection.It is unknown if the physician believed that the dissection was caused by the first stent.The physician completed the procedure using another resolute onyx of the same size without complication.The patient status post procedure is alive with no further injuries reported.

• 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: 7036356
• Report Number: 9612164-2017-01618
• Device Sequence Number: 11045839
• Product Code: NIQ
• UDI-Device Identifier: 00643169557055
• UDI-Public: 00643169557055
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 11/16/2017

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: 01/26/2019
• Device Catalogue Number: RONYX35008UX
• Device Lot Number: 0008471918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR