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

Catalog Number	RONYX22518W
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 12th distal stent segments with struts raised.Slight deformation was evident to the distal tip, with tip being uneven.The inner lumen patency was verified.(b)(4).
Event or Problem Description
The physician was intending on using a resolute onyx drug eluting stent in a patient's heavily calcified and very tortuous proximal circumflex lesion with 95% stenosis.No damage was noted to the packaging and there was no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was performed and the lesion was pre-dilated with a 2.5 balloon.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 stent deformation in vivo during positioning occurred.The physician attempted multiple times to position the stent in the lesion.Upon removal of the device, the physician noted that a strut was bent out of line.The lesion was predilated with a 3.0 nc balloon and a new resolute onyx.Stent was used to complete the procedure.The patient was discharged from the hospital the day after the procedure.The patient is alive with no injury.

• Brand Name: RESOLUTE ONYX OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7017669
• Report Number: 9612164-2017-01590
• Device Sequence Number: 19268707
• Product Code: NIQ
• UDI-Device Identifier: 00643169602243
• UDI-Public: 00643169602243
• 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
• Report Date (Section B): 11/10/2017

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: 06/16/2019
• Device Catalogue Number: RONYX22518W
• Device Lot Number: 0008682479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1