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

Catalog Number	RONYX27518UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
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 and attempt was made to use a resolute onyx rx coronary, drug eluting stent to treat a lesion.It is indicated on a non compliant product replacement request form that stent deformation occurred trying to cross the lesion.There is no patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: a stopcock was returned attached to the device.A tactile test confirmed kinks were evident to hypotube and distal shaft.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 5th, 14th and 15th distal stent wraps with struts raised.Misalignment of struts was evident to the 10th distal stent wrap.Deformation was evident to the distal tip.The inner lumen patency could not be verified with a 0.015 inch mandrel due to a kink on the distal shaft.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The lesion was in the lad.Calcification was significant.The vessel was not tortuous.The stenosis was significant in the 90-95% range.The stent and delivery system were inspected before entry into the guide, with no issues noted.The lesion was pre-dilated.There was resistance at entry into the lesion.Prior to lesion entry there was no resistance.Additional dilatation was performed at the lesion site.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: 8643927
• Report Number: 9612164-2019-01965
• Device Sequence Number: 254839
• Product Code: NIQ
• UDI-Device Identifier: 00643169556904
• UDI-Public: 00643169556904
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2019

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: 03/26/2021
• Device Catalogue Number: RONYX27518UX
• Device Lot Number: 0009659580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/28/2019; 09/16/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 06/26/2019; 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 93