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

Catalog Number	RONYX22538UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a resolute onyx drug eluting stent to treat a severely tortuous, severely calcified lesion in the mid-distal left anterior descending (lad).The lesion was heavily calcified and csi was used to reduce some calcium.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It is reported that stent deformation occurred in vivo during positioning.The procedure was completed using another 2.25x38mm resolute onyx device.No patient injury is reported.
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 16th stent wrap, with struts raised.No deformation was evident to the distal tip.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: 7333361
• Report Number: 9612164-2018-00498
• Device Sequence Number: 13549786
• Product Code: NIQ
• UDI-Device Identifier: 00643169556775
• UDI-Public: 00643169556775
• 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): 04/25/2018

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: 10/17/2019
• Device Catalogue Number: RONYX22538UX
• Device Lot Number: 0008839425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1