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

Catalog Number	RONYX22522UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Occlusion (1984)
Date of Event	01/29/2019
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 3 resolute onyx des were implanted i the 1st obtuse marginal, 2nd obtuse marginal and rca.It was reported the same day post procedure there was no reflow which was treated with medication.Patient is recovered.Investigator assessed the event as not related to the anti-platelet medication or index device.Sponsor assessed the event as not related to the anti-platelet medication but possibly related to the index device.
Additional Manufacturer Narrative
Patient has a previous medical history of hypertension, hyperlipidaemia, stroke, previous mi, previous pci and copd.Index procedure was prompted by unstable angina and evidence of ischaemia.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Three resolute onyx des were implanted on (b)(6) 2019 not (b)(6) 2019 as previously reported.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It was confirmed that no occlusion or thrombus took place.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec adjudicated that the no flow event was a target vessel (rca) non-q- wave mi, 3rd udmi peri-pci.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: 8420728
• Report Number: 9612164-2019-00884
• Device Sequence Number: 1795575
• Product Code: NIQ
• UDI-Device Identifier: 00643169556737
• UDI-Public: 00643169556737
• 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): 06/07/2019

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: 05/08/2020
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0009135074
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/17/2019; 04/18/2019; 04/18/2019; 05/18/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/08/2019; 05/09/2019; 05/09/2019; 06/07/2019
• 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: Other
• Patient Weight: 54