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

Catalog Number	RONYX27512UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use a resolute onyx drug eluting stent to treat a severely tortuous, severely calcified lesion in the mid lad.The lesion was pre-dilated.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It is reported that stent deformation occurred during removal from the patient following attempted delivery to the lesion.On inspection it was noted that the struts were poking up.There is no patient injury.

• 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: 6910066
• Report Number: 9612164-2017-01356
• Device Sequence Number: 117460
• Product Code: NIQ
• UDI-Device Identifier: 00643169556881
• UDI-Public: 00643169556881
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/05/2017

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: 03/11/2019
• Device Catalogue Number: RONYX27512UX
• Device Lot Number: 0008532724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1