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

Model Number	RONYX45018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
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
During the procedure, an attempt was made to use one resolute onyx drug eluting stent to treat a moderately tortuous and severely calcified lesion located in the proximal left main artery.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues identified.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.Excessive force was not used during delivery.It was reported that the stent was advanced through a non-medtronic guide extension catheter to proximal/mid left main.Difficulty due to calcification and lesion crossability was noted.The stent was removed to inspect the stent prior to crossing again and it was noted that stent strut deformation occurred.The procedure was completed using a medtronic stent without any issues.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: there were two kinks on the hypotube 44.7cm and 92.1cm distal to the strain relief.Stent is positioned correctly between the marker bands but did not meet specifications due to the deformation.Deformation was evident to the first and second distal stent wraps with struts raised and bunched.Deformation was evident to the distal tip.The 0.015 inch mandrel could not load through the guidewire lumen due to hardened blood in the guidewire lumen.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: 7693284
• Report Number: 9612164-2018-01773
• Device Sequence Number: 11115177
• Product Code: NIQ
• UDI-Device Identifier: 00643169557253
• UDI-Public: 00643169557253
• 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,Followup
• Report Date (Section B): 10/09/2018

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: 02/08/2020
• Device Model Number: RONYX45018UX
• Device Lot Number: 0008982906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/10/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR