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

Model Number	RONYX20015UX
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
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 moderately tortuous, moderately calcified lesion.There were no issues removing the device from the packaging.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered and excessive force was not used.It was reported that the stent was unable to be delivered to the lesion with it being removed and attempted multiple times, it was inspected again after removal before each attempt.It was noted that the stent was not able to be delivered to the lesion due to difficult anatomy.On the final attempt the stent did cross the lesion and the balloon was inflated to deploy the stent.There were no inflation difficulties.It was reported that upon its removal the stent was still on the balloon and was noted to be severely deformed.It is stated that it was thought the tuohy adapter was too tight and the stent 'accordianed' there.It is also stated that it was thought not to be the stent's fault.
Additional Manufacturer Narrative
Product analysis summary: the device returned with a non-medtronic stop-cock attached to the luer.The stent was not positioned on the balloon between the marker bands.It was severely bunched and deformed, and was located over the proximal marker-band.Stent measurements could not be recorded due to the nature of deformation.Balloon folds were expanded with contrast visible in between balloon folds.A kink was evident to the distal shaft, with the underlying inner member and support wire also kinked.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.

• 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: 9609680
• Report Number: 9612164-2020-00344
• Device Sequence Number: 16748305
• Product Code: NIQ
• UDI-Device Identifier: 00643169556645
• UDI-Public: 00643169556645
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/23/2020

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: 08/15/2021
• Device Model Number: RONYX20015UX
• Device Catalogue Number: RONYX20015UX
• Device Lot Number: 0009877494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR