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

Catalog Number RONYX22512JX

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

Patient Problems Chest Pain (1776); Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

One resolute onyx coronary drug eluting stent was implanted.It was reported that late stent thrombosis occurred approximately 3 months post stent implant.

Manufacturer Narrative

Additional information: patient weight.Procedural notes were provided.It was indicated that lad lesion #7 segment 2 was being treated.It was indicated that this area had 99% stenosis.It was also indicated that the device was inflated twice at 14 atm for 20 seconds.It was also indicated that the patient was on dapt at the time of implant.Additional information as per report received states that the patient has since recovered.It is indicated that the stent was implanted in the patient for treatment of an subacute myocardial infarction after presentation with angina.It was later stated that the calcified lesion was located in the mid-right lad.The lesion was pre-dilated but post-dilation was not carried out.An inflation pressure of 11 atms was applied for 11 seconds at the medial and proximal positions, and 14 atm for 20 seconds at the distal position for stent deployment.It was noted that post-operative stenosis was 0% with no issues noted after stent implantation.The patient was kept on antiplatelet therapy continually from the date of stent implantation.It was mentioned that 10 days prior to stent thrombosis having occurred, the patient experienced chest pain and increase in troponin levels.Upon cag being carried out 10 days later, obstruction was observed at segment 2 inside the stent.A non-medtronic stent was then implanted within the ronyx stent to treat the late/ very late stent thrombosis.It was also stated that no damage occurred to the blood vessel during ronyx stent implantation.It was commented that dapt adherence was good and there were no mastocytosis.It was also stated that it is thought the adverse event was due to severe calcification.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.

Manufacturer Narrative

Additional information: the target lesion being treated was the right coronary artery (rca) lesion #2.Image analysis: images showed a total occlusion at the level of the mid-rca.Subsequent ballooning and stent deployment resolved the occlusion resulting in timi 3 flow throughout the vessel.The lesion in the mid rca appeared to contain a thrombus at the site where there was serve calcification.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: 10711271
• MDR Text Key: 212305960
• Report Number: 9612164-2020-04029
• Device Sequence Number: 1
• Product Code: NIQ
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2021
• Device Catalogue Number: RONYX22512JX
• Device Lot Number: 0010003814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 53