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

Catalog Number	RONYX27515W
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	01/17/2018
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
The physician intended to use a resolute onyx drug eluting stent to treat a mildly tortuous, mildly calcified lesion in the mid lad.No abnormalities were 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.Negative prep was performed with no issues.The lesion was pre-dilated.The device passed through a previously deployed stent.No resistance was encountered when advancing the device.Excessive force was not used.The physician was trying to pass the resolute onyx stent through existing older unknown brand stent, and it got caught on the previously placed stent.The device failed to cross the lesion.It was reported that the stent deformation occurred in vivo during positioning.The physician completed the procedure with a medtronic product.No patient injury was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7246909
• Report Number: 9612164-2018-00216
• Device Sequence Number: 13690433
• Product Code: NIQ
• UDI-Device Identifier: 00643169602410
• UDI-Public: 00643169602410
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/24/2018

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: 02/13/2019
• Device Catalogue Number: RONYX27515W
• Device Lot Number: 0008493579
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 98