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

Model Number RONYX35030UX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Thrombus (2101)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure four resolute onyx rx coronary drug eluting stents were implanted to treat a severely tortuous, moderately calcified lesion located in the ostium, proximal, mid and distal right coronary artery (rca).100% stenosis was present.All devices were inspected with no issues noted.Negative prep was performed on all four devices with no issues noted.The lesion was not pre-dilated.The devices did pass through previously deployed stents.Resistance was encountered when advancing all four devices but excessive force was not used during delivery of any of the devices.It was reported that acute stent thrombosis occurred less than 24 hours post stent implantation and an mi occurred in relation to the target vessel 7 hours post stent implantation.The clot was removed by aspiration with a non medtronic device.The patient was reported to be alive with no injury.

Manufacturer Narrative

Cine image review summary: the images provided revealed stent thrombosis within a previously implanted stent at prox (bms)/mid (des) rca.A severely tortuous, moderately calcified and diffused lesion from prox to mid to dist rca was noted.Full metal jacket method was used to treat the vessel.Review of the images indicates that post-dilation may have been insufficient.No intravascular imaging observed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the devices were deployed with no issues and were fully expanded.The patient was on dapt when the thrombotic event occurred.The physician did not comment on the relationship between the thrombus and the relevant device.The patient did not have any relevant patient medical history that may have made the patient more prone to the event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9590993
• MDR Text Key: 175041299
• Report Number: 9612164-2020-00240
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557116
• UDI-Public: 00643169557116
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: RONYX35030UX
• Device Catalogue Number: RONYX35030UX
• Device Lot Number: 0009778583
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 01/21/2020; 04/03/2020; 04/17/2020
• Supplement Dates FDA Received: 02/12/2020; 04/16/2020; 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 78