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

Model Number	RONYX22508UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the index procedure one resolute onyx stent was implanted into the 1st diagonal branch.It was reported that plaque / carina shift occurred.This was treated by implantation of one resolute onyx stent into the 1st diagonal branch and one resolute onyx stent into the lad.The patient recovered.The investigator assessed the event as causally related to the index device and not related to anti-platelet medication.
Additional Manufacturer Narrative
Sponsor assessed the event as causally related to the device and not related to the anti-platelet medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It was reported that the plaque shift occurred during implantation of two resolute onyx stents (0008835623 and 0008841599) during the index procedure.The plaque shift was treated with the implantation of one other resolute onyx stent.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: 8334632
• Report Number: 9612164-2019-00501
• Device Sequence Number: 1692576
• Product Code: NIQ
• UDI-Device Identifier: 00643169556690
• UDI-Public: 00643169556690
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2019
• Device Model Number: RONYX22508UX
• Device Lot Number: 0008835623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 01/23/2019; 03/07/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 02/18/2019; 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 114