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

Model Number RONYX35038X

Device Problems Burst Container or Vessel (1074); Fracture (1260)

Patient Problems Chest Pain (1776); Insufficient Information (4580)

Event Date 01/30/2023

Event Type  Death  

Event Description

The patient was admitted for an elective percutaneous coronary intervention (pci).Angiography of the acd/right coronary artery (rca) showed a tortuous lesion with shepherd's crook, with intensely calcified lesion of 70% in the proximal third, and intensely calcified lesions of 50% in the middle and distal thirds.An attempt was made to use one 3.5x38mm resolute onyx coronary drug eluting stent (des) to treat a moderately tortuous, severely calcified lesion with 70-90% stenosis in the mid-distal rca.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that the 3.5x38mm resolute onyx des fractured at the body of the stent catheter during advancement.It was also reported that the balloon ruptured during navigation.It was detailed that initial intravascular ultrasound (ivus) study of the rca showed diffuse fibro-calcified atheromatosis, with intense calcification.A new ivus run was attempted without success and there was a probable fracture of the ivus catheter.Images were not obtained.Rotoblation was performed.Multiple and sequential pre-dilations were then performed in the proximal/mid avpd artery, and the proximal, mid and distal dca artery with a 2.0x12mm sc balloon.A 3.0x38mm resolute onyx des, was implanted in the distal rca/proximal-mid avpd and inflated to 12 atm.Multiple and sequential post-dilations were performed with a 3.25x12mm nc balloon up to 24 atm.Multiple attempts were made to implant the 3.5x38mm resolute onyx des in the mid third of the dca without success, with fracture of the body of the stent catheter and deterioration of the al 1 guide catheter.The guide catheter was changed to a jr 4 device.A second extra-support guidewire was passed through the distal bed of the dca, followed by the implantation of a 4.0x38mm resolute onyx des in the proximal rca, inflated to 12 atm, and a 3.5x34mm resolute onyx des in the proximal-mid rca, in overlap fashion, inflated to 12 atm.Multiple and sequential post-dilations were performed with the stent balloon up to 24 atm.Several attempts were made to cross with various devices.Control angiography of the rca was performed with patent ppv and well implanted and expanded stents and distal timi 3 flow.It was stated that the fracture of the devices occurred due to the complex anatomical characteristics of the target artery.The patient progressed post procedure in a stable manner with a complaint of mild chest pain.It was later confirmed that the patient deceased.

Manufacturer Narrative

Image analysis: one still image was received for analysis.The image shows the sterile sleeve of a resolute onyx.The lot number and size can be confirmed from the image provided.Lot number 0011295759 and size 3.5mm x 38mm.Unable to confirm the reported malfunction from the image provided.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18950791
• MDR Text Key: 338255381
• Report Number: 9612164-2024-01388
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX35038X
• Device Catalogue Number: RONYX35038X
• Device Lot Number: 0011295759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Date Device Manufactured: 07/08/2022
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 69 KG