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

Model Number	RONYX35022UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	10/09/2019
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 des was used to treat the lad.26 months post index procedure during a revascularisation procedure one nc euphoria balloon catheter and one resolute onyx des were used and plaque shift occurred and was treated with implant of a resolute onyx des.
Additional Manufacturer Narrative
Additional information: the investigator assessed the event was not related to index device or anti-platelet medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: patient recovered.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: patient recovered.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: investigator assessed the event was unlikely related to index device or antiplatelets medication.Correction: event date (b)(6) 2019.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: 9503734
• Report Number: 9612164-2019-05281
• Device Sequence Number: 1838952
• Product Code: NIQ
• UDI-Device Identifier: 00643169557093
• UDI-Public: 00643169557093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup,Followup
• Report Date (Section B): 02/21/2020

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: 07/09/2021
• Device Model Number: RONYX35022UX
• Device Catalogue Number: RONYX35022UX
• Device Lot Number: 0009822702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2019
• Supplement Date Received by Manufacturer: 01/21/2020; 11/23/2019; 11/23/2019; 02/19/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/28/2020; 02/19/2020; 02/19/2020; 02/21/2020
• 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: 68 YR
• Patient Weight: 84