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

Catalog Number	RONYX22530UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
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
Physician intended to use resolute onyx drug eluting stent to treat a lesion.The stent was inspected after removal from hoop with no known damage.The device failed to cross the intended lesion and upon removal of device from patient stent damage was noted.It is reported that the damage was caused by the calcific lesion.An attempt was made to cross the lesion with two different manufacturers stent, however, the procedure could only be completed by ballooning.
Additional Manufacturer Narrative
Several attempts were made to cross the lesion with the resolute onyx stent.A guide liner was used for support.The damage to the stent was also caused by tight stenosis.The procedure was completed with a shorter onyx stent and not a balloon as previously reported.(b)(4).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: 7281874
• Report Number: 9612164-2018-00374
• Device Sequence Number: 1133432
• Product Code: NIQ
• UDI-Device Identifier: 00643169556751
• UDI-Public: 00643169556751
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: 09/19/2019
• Device Catalogue Number: RONYX22530UX
• Device Lot Number: 0008801866
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1