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

Model Number RONYX22526X

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2024

Event Type  malfunction  

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

During a procedure two resolute onyx coronary drug eluting stents were used to treat a moderately calcified, non-tortuous lesion exhibiting 95% stenosis located in the ostium of the circumflex (cx) artery. the device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The resolute onyx stent (lot 0226094749) device was not kinked and re-straightened during use.It was reported that the device detached, cracked, or fractured during delivery through the vessel.The detached portion of the device does not remain in the patient and the device was removed with the catheter before dilating the stent.The patient is alive with no injury.

Manufacturer Narrative

Additional information: force used during advancing the devices was the same as normal.It was later detailed that the device fracture did not cause the catheter to separate into 2 parts, and the stent did not dislodge from the balloon.However the stent has wrinkled and changed shape due to calcium.No resistance was encountered during withdrawl of the device and excessive force was not used.The onyx (lot 0011468414) was taken out of the hub and prepared for use as usual with every step without bending.The stent device was kinked prior to engaging in the lesion.The device was successfully removed from the patient.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: 19086345
• MDR Text Key: 340345292
• Report Number: 9612164-2024-01733
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX22526X
• Device Catalogue Number: RONYX22526X
• Device Lot Number: 0011468414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Date Device Manufactured: 10/24/2022
• 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 Age: 74 YR
• Patient Sex: Male