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

Model Number	RONYX27508UX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2017
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
It was reported that the physician intended to use resolute onyx rx drug eluting stent to treat a moderately tortuous and severely calcified lesion located in the proximal circumflex artery, exhibiting 86% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was used during delivery.It was reported that the physician tried to advance the stent but it would not deliver after pre-dilation, rotational atherectomy system (rotablator) and use of a non medtronic guide extension catheter.It was reported that too much calcium was present.It was reported that stent deformation occurred in vivo during positioning.A ronyx27508ux was used to complete the procedure.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 1-3rd stent wraps with struts stretched and bunched.Deformation was evident to the distal tip, with tip appearing torn.The inner lumen patency was verified.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: 7159571
• Report Number: 9612164-2018-00013
• Device Sequence Number: 16159046
• Product Code: NIQ
• UDI-Device Identifier: 00643169556874
• UDI-Public: 00643169556874
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 01/15/2018

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: 03/15/2019
• Device Model Number: RONYX27508UX
• Device Catalogue Number: RONYX27508UX
• Device Lot Number: 0008536307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 95