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

Catalog Number RONYX30018X

Device Problems Premature Activation (1484); Device Dislodged or Dislocated (2923)

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

Event Date 12/28/2022

Event Type  malfunction  

Event Description

An attempt was made to use one resolute onyx drug eluting stent to treat a severely tortuous, severely calcified lesion with 100% chronic total occlusion (cto), located in the mid/distal right coronary artery (rca).The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that the stent did not advance towards the lesion.The stent did not pass through the tortuosity.Medical or surgical intervention was not needed to prevent a permanent impairment of a function.The event did not lead to or extend patient hospitalization.The patient is alive with no injury.

Manufacturer Narrative

Product analysis: the device was returned for analysis.Kinks were evident on the hypotube.The stent returned on the balloon, however partial expansion of the proximal and distal stent wraps was evident.A partial deployment of the stent had occurred.The stent had also displaced distally and was not positioned on the balloon between the markerbands as per specifications.No deformation evident to the stent wraps.Crimp impressions were visible on the exposed balloon surface.No deformation evident to the distal tip.A 0.015 inch mandrel would not load through the inner lumen most likely due to hardened blood and/or contrast/ deformation in the guidewire lumen.The balloon was inflated to a nominal of 12atm, and the stent expanded with no issues noted.No other damage evident to the remainder of the device.Image analysis: two still fluoroscopic images were provided.One image identifies that the angulation into the ostium and through the proximal rca is tortuous.The proximal to distal vessel appears diffusely diseased and tortuous.The other image identifies the severely tortuous, severely calcified mid to distal vessel that most likely impacted on device delivery.No evidence of the device in the images.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.

• 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: 16500790
• MDR Text Key: 311109830
• Report Number: 9612164-2023-01024
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2024
• Device Catalogue Number: RONYX30018X
• Device Lot Number: 0011186722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• 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: 80 YR
• Patient Sex: Male