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

Model Number	RONYX22518UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Thrombus (2101)
Date of Event	01/30/2020
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
The patient presented with an (b)(6).A resolute onyx coronary drug eluting stent was used to treat a moderately tortuous, moderately calcified lesion with 99% stenosis in the obtuse marginal (om) artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that approximately one week post implant, the patient returned with stent thrombosis.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Additional information: the resolute onyx stent was fully expanded.The patient was on dapt during the thrombotic event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cine images were returned for evaluation.Critical stenosis (99%) at obtuse marginal artery (om1).Large and long vessel in a bifurcation medina.Chronic total occlusion (cto) observed on the proximal right coronary artery (rca).Om1, gw, balloon, stent, plaque shift, post dilation but no pot and no sb treatment.Multivessel disease with critical om1 type c (eccentric & irregular) lesion (99%) and cto proximal rca.Om1 was revascularized.Rca lesion was unsuccessful attempted.No intravascular imaging used.St of om1 successfully treated 2x stents.Rca treated as well 2x stents, complicated w/ao dissection.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
This event with patient id (b)(6) is the same event as patient id (b)(6) reported through regulatory report 9612164-2020-00914.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the stent was post-dilated.0% residual stenosis was noted post intervention.The obtuse marginal was also 100% occluded.The event was treated with ballooning and stenting.Relevant history updated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 9675716
• Report Number: 9612164-2020-00592
• Device Sequence Number: 16997749
• Product Code: NIQ
• UDI-Device Identifier: 00643169556720
• UDI-Public: 00643169556720
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/15/2020

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: 09/30/2021
• Device Model Number: RONYX22518UX
• Device Catalogue Number: RONYX22518UX
• Device Lot Number: 0009948110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 02/06/2020; 03/18/2020; 04/03/2020; 04/17/2020; 04/17/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/27/2020; 03/30/2020; 04/16/2020; 04/20/2020; 05/15/2020
• 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: Hospitalization
• Patient Age: 80 YR
• Patient Weight: 59