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

Model Number	RONYX20015UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: resistance was noted while advancing the device to the lesion.Force was used but excessive force was not used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 14th 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.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
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A resolute onyx rx drug eluting stent was attempted to be used to treat a moderately tortuous, moderately calcified lesion with 90% stenosis in the distal rca.The device was inspected prior to use with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.It was reported that stent deformation occurred in vivo during positioning.Another resolute onyx rx device was used to complete the procedure.No patient injury 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: 9435761
• Report Number: 9612164-2019-05042
• Device Sequence Number: 17062571
• Product Code: NIQ
• UDI-Device Identifier: 00643169556645
• UDI-Public: 00643169556645
• 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,Followup
• Report Date (Section B): 02/17/2020

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: 09/19/2020
• Device Model Number: RONYX20015UX
• Device Catalogue Number: RONYX20015UX
• Device Lot Number: 0009335838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 12/10/2019; 01/23/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/12/2019; 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 93