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

Model Number RONYX35022JX

Device Problem Burst Container or Vessel (1074)

Patient Problems Non specific EKG/ECG Changes (1817); Insufficient Information (4580)

Event Date 04/24/2024

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

An attempt was made to use one resolute onyx coronary drug eluting stent (des) to treat a non-tortuous lesion with 75% stenosis located in the mid (#2) right coronary artery (rca) for direct stenting.The device was inspected prior to use with no problems observed.Negative prep was performed with no problems observed.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance/discomfort was not encountered when delivering the device.Excessive force was not used during delivery.It was reported that balloon rupture occurred during initial balloon inflation at 6 atm.When the balloon was being pulled forward, it came out every time it was being used to stent, but extended to 12 atm.There was no coronary perforation, but st elevation and thoracic distress occurred.A non-medtronic 4.0x15mm nc balloon was used at 6 atm for 10 seconds, and nicorandil was given.The st gradually decreased.Lepetan 0.5a was given intravenously.Timi 3 flow was then present.The resolute onyx des was implanted in the distal lesion and inflated at 14 atm for 10 seconds, 16 atm for 5 seconds, 18 atm for 5 seconds, and 20 atm for 5 seconds.The lesion was post-dilated with a non-medtronic 4.0x15mm nc balloon at 14 atm for 15seconds, and 22 atm for 5seconds x3.Intravascular ultrasound (ivus) was performed.Final result of the mid rca showed stenosis reduced from 75% to 0% with timi 3, and successful percutaneous coronary intervention (pci) with a des to the rca lesion.A 6f launcher guide catheter was also used during the procedure.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: the device was moved or repositioned in the lesion while inflated.There is no complaint against the launcher device used.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.

Manufacturer Narrative

Additional information: the non-medtronic 4.0x15mm nc balloon was used for post expansion.The 3.5x22mm resolute onyx stent was placed in the intended position.Correction: intravascular ultrasound (ivus) was performed showing fibrotic plaque.A 3.5x12mm resolute onyx des was implanted in the distal lesion and inflated at 14 atm for 10 seconds, 16 atm for 5 seconds, 18 atm for 5 seconds, and 20 atm for 5 seconds.This stent implantation was scheduled as part of the procedure.Image analysis: four fluoroscopic images were provided showing the injection of contrast into the rca confirming a mid-vessel lesion.Subsequent images show the presence of the stent across the lesion with the proximal and distal stent partially deployed in a dog-boned fashion.This may suggest balloon inflation issues, but as only still images were provided leaking of contrast into the vessel cannot be confirmed.An ivus image was provided and appears to confirm the calcific nature of the lesion being treated.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: 19211070
• MDR Text Key: 341356246
• Report Number: 9612164-2024-02047
• 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
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX35022JX
• Device Catalogue Number: RONYX35022JX
• Device Lot Number: 0011725101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Date Device Manufactured: 04/14/2023
• 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): Required Intervention; Other