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

Catalog Number	RONYX45030UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2018
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
An attempt was made to use a resolute onyx rx drug eluting stent to treat a severely calcified and moderately tortuous lesion.It was reported that no damage was noted to the device packaging and there were no issues removing the device from the hoop/tray.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and no excessive force used.It was reported that the device failed to cross the target lesion.The stent failed to cross and was removed.Upon removal of the stent, the guide moved out of the left main and the physician tried to put the stent back into the guide but the struts had been damaged when it rubbed against the guide upon initial removal and struts were lifted.The physician used two smaller sized onyx stents to complete the procedure.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis summary: numerous kinks were visible along the hypotube.The stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 27th, 29th and 30th distal stent wraps with struts raised and bunched.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: 7333339
• Report Number: 9612164-2018-00496
• Device Sequence Number: 377084
• Product Code: NIQ
• UDI-Device Identifier: 00643169557284
• UDI-Public: 00643169557284
• 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
• Report Date (Section B): 04/09/2018

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: 11/03/2019
• Device Catalogue Number: RONYX45030UX
• Device Lot Number: 0008865432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR