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

Catalog Number RONYX20015JX

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

Patient Problems Cardiac Arrest (1762); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 11/11/2022

Event Type  Death  

Event Description

During a pci procedure to treat stable angina, one taiga guide catheter and one resolute onyx coronary drug eluting stent were used to treat a lesion exhibiting 90% stenosis located in the mid left anterior descending artery (lad) and a lesion located in the first diagonal branch.Using an approach from the left radial artery, the taiga guiding catheter was engaged in the coronary artery.A non-medtronic (mdt) guidewire was inserted into the target lesion.A non-mdt ivus catheter was inserted into the blood vessel and the lesion was observed.The lesion was pre-dilated using a non-medtronic 2x15mm ptca balloon catheter and the lesion was observed again using the ivus catheter.A non-mdt 3x18mm coronary stent was placed in the mid lad.The first diagonal branch was expanded so that the non-mdt stent was opened using the 2x15mm non-mdt ptca balloon catheter.It was reported that an acute thrombus had developed in the lad.Chest pain was observed, so a nitorol sodium hydrate injection solution was administered.A non-mdt thrombus suction catheter was used to aspirate the lad thrombus.Thrombus was also observed on the proximal side of the first diagonal branch, and the non-mdt 2x15mm ptca balloon catheter was used for expansion.As a thrombus also developed in the non-mdt 3x18mm stent, the proximal side of the stent was expanded using another non-mdt 3x8mm ptca balloon catheter.A red thrombus in the non-mdt 3x18mm stent was aspirated using the non-mdt thrombus suction catheter.A decrease in the flow of the first diagonal branch was observed, and so it was expanded using the 2x15mm non-mdt ptca balloon catheter.As further thrombus was observed in the lad, a nitorol sodium hydrate injection solution was administered, and after repeating the thrombus suction and the expansion using the 2x15mm non-mdt balloon catheter, a 2x15mm resolute onyx coronary drug eluting stent was placed in the first diagonal branch.Thrombosis was confirmed in the peripheral region of the distal portion of the lad branch.The procedure was completed after confirming that there was almost no thrombus in the stent in the final contrast study.After returning to the operating room, the patient's hand was confirmed to be swollen; extravasation of heparin was suspected, so the drip was resumed and heparin administration was performed.A cerebral infarction occurred within 30 minutes after the procedure was completed.Cardiac arrest was confirmed during an mri examination.An angiography was per formed again under intra-aortic balloon pump (iabp), and recovery of the flow was confirmed by administering heparin.The patient's consciousness was restored and the patient could have a conversation.After returning to the room immediately after surgery, the patient's blood pressure decreased and the patient's death was confirmed.The cause of death is unknown.It was stated that it is unknown whether the stent thrombosis directly led to the cause of death.It was stated that it is possible that the thrombus also developed in other organs due to a extravasation of heparin, and that the patient died of multiple organ failure as a result of the ischemia.It was stated that there were no problems with the device's expansion, and there were no problems with the procedure itself.The patient had been administered aspirin 100mg/day and prasugrel 3.75mg/day since (b)(6) 2022 and continued until day of surgery.

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.

Manufacturer Narrative

Additional information: annex d code.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: 15968119
• MDR Text Key: 305329237
• Report Number: 9612164-2022-04701
• 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
• Report Date: 12/19/2022

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 Catalogue Number: RONYX20015JX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/19/2022
• 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: 82 YR
• Patient Sex: Female