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

Catalog Number RONYX27538JX

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

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 03/26/2023

Event Type  Death  

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.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.

Event Description

The patient was hospitalized four months ago for treatment of chronic limb-threatening ischemia (clti).Coronary angiography was performed at the time to examine the complications of ischemic heart disease.The left anterior descending (lad) artery was observed to be moderately calcified, mildly tortuous with 75% stenosis.Three months later a percutaneous coronary intervention (pci) was performed electively for the stenosis lesion in lad.One 2.75 x 38mm resolute onyx coronary drug eluting stent was implanted.The device was inspected prior to use with no problems observed.Negative prep was performed with no problems observed.The lesion had been pre-dilated twice with a 2.5 x 10mm non-medtronic balloon.The remaining stenosis rate after pre-dilation was described as good.The device did pass through a previously deployed stent.Resistance/discomfort was not encountered when delivering the device.Excessive force was not used.The stent was post-dilated and post-operative stenosis rate was 0%.Timi flow 3 was observed pre and post operative.The patient was discharge two days later.Four days post stent implantation, the patient had chest pain and was diagnosed with anterior wall infarction.An emergency coronary angiogram was performed and the patient was diagnosed with subacute stent thrombosis.Six days post stent implantation a pci was performed.A balloon was inflated inside the stent in the lad, after a thrombi was aspirated.Stenosis was observed in the distal region of the stent, therefore a second 2.5 x 26mm resolute onyx stent was placed in the lad.The patient initially recovered.However, the patient's condition became unstable and the patient died three weeks later after intra-aortic balloon pump (iabp).The patient was on aspirin 100mg/day and clopidogrel 75mg/day since the hospital admission four months earlier.The patient stopped clopidogrel the following day to change to prasugrel.The patient also received 8000 units of heparin pre-operative.The cause of death is unknown and it is unlikely that the patient died of thrombosis.

Manufacturer Narrative

Additional information: as per the physician the cause of death is unknown and therefore, the casual relationship between the devices and the patient death is unknown.Image analysis: three still images showing the left coronary system with proximal lad stenosis with a previously deployed stent in the left main.Post 2.75 x 38mm resolute onyx stent the remaining stenosis rate after was good.Timi flow 3 was observed pre and post operative.On (b)(6) two images were provided from the account for on (b)(6).The images confirm the presence of a thrombus in the proximal lad stent.The thrombus was resolved and a stent successfully deployed restoring timi iii flow in the vessel.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.

Manufacturer Narrative

Additional information: in order to support root cause determination medical safety review was performed by a medtronic medical safety consultant.Medical safety review could not establish a definitive causality.It was determined from the history that the stents were directly related to the thrombosis and the stents are not excluded as a causative factor for death.Annex d code.Correction: facility name and address translated to english.Facility phone number provided.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: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16782853
• MDR Text Key: 313705571
• Report Number: 9612164-2023-01694
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2023

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: 10/07/2023
• Device Catalogue Number: RONYX27538JX
• Device Lot Number: 0010885231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 04/26/2023; 05/08/2023
• Supplement Dates FDA Received: 05/23/2023; 06/06/2023
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 57 KG