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

Model Number	RONYX25026UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
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
A resolute onyx rx coronary drug eluting stent was attempted to be used to treat a mildly calcified, mildly tortuous lesion in the lad.There was no damage noted to the packaging or any issues noted when removing the device from the hoop.The stent was inspected prior to use.It was stated that the stent went into the body through a guideliner.An attempt was made to deliver the stent to the lesion but resistance was felt and the stent was removed.Excessive force was not used.It was reported that upon inspection once removed, it was noticed that the stent strut had been lifted and was set aside.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to a number of distal stent wraps with struts raised.Slight deformation was evident to the distal tip.There was 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: 9481053
• Report Number: 9612164-2019-05203
• Device Sequence Number: 16698576
• Product Code: NIQ
• UDI-Device Identifier: 00643169556836
• UDI-Public: 00643169556836
• 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): 01/30/2020

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: 09/11/2021
• Device Model Number: RONYX25026UX
• Device Catalogue Number: RONYX25026UX
• Device Lot Number: 0009916585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1