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

Model Number	RONYX20008UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
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 an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a moderately tortuous and calcified lesion in the proximal portion of an artery.The device was inspected with no issues noted.Negative prep was performed without issue.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device, however excessive force was not used during delivery.It was reported that stent deformation occurred in vivo when pulling the stent back into the guideliner.It was indicated that a strut of the stent got caught on the edge of the guideliner and lifted.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
The stent would not cross the lesion.The stent was not deployed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The device was returned.The stent was positioned between the markerbands but not meeting specifications due to deformation of the distal wraps.Deformation was evident to the 1st distal stent wraps with struts raised and bunched.Multiple bends were evident on the hypotube which are consistent with coiling the device for return.No deformation was evident to the distal tip.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: 8460360
• Report Number: 9612164-2019-01081
• Device Sequence Number: 19577673
• Product Code: NIQ
• UDI-Device Identifier: 00643169556621
• UDI-Public: 00643169556621
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/20/2019

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: 02/18/2020
• Device Model Number: RONYX20008UX
• Device Catalogue Number: RONYX20008UX
• Device Lot Number: 0008999057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/28/2019; 05/14/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/26/2019; 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1