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

Model Number RONYX22522X

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976); Positioning Problem (3009)

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

Event Date 01/22/2024

Event Type  malfunction  

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.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.

Event Description

An attempt was made to use one resolute onyx drug eluting stent (des) to treat a lesion with significant perfusion restriction in the middle of the left circumflex (lcx).The patient was treated with percutaneous coronary intervention (pci) due to unstable angina.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated with a non-medtronic semi-compliant balloon. it was reported that stent deformation occurred following a failed delivery.It was detailed that there was difficulty wiring down to the distal lcx due to the lesion at the ostium of the lcx but this was successful.When attempting to deliver a non-medtronic des, it failed to pass through the lcx ostium.This resulted in the guiding disengaging from the left main coronary artery (lm).A resolute onyx stent was then attempted to be delivered however, without success.When removing the resolute onyx stent system, stent deformation occurred when pulling the system from the y-connector.No patient injury was reported.

Manufacturer Narrative

Additional information: the lesion being treated was a non-tortuous lesion with over 90% stenosis in the mid left circumflex artery (lcx) at the junction of the 1st obtuse marginal artery (om).The lesion was found to be just distal to the ostium of the oblique marginal ostium with no significant lesion found in segment of the lcx proximal of the om ostium.The device did not pass through a previously deployed stent.Resistance was noted while advancing the device to the lesion.No excessive force was used.A non-medtronic guidewire was used in the procedure.A launcher guide catheter disengaged from the left main coronary artery (lm).A non-medtronic percutaneous old balloon angioplasty (poba) was used to complete the procedure.There were no issues noted with the launcher guide catheter.The patient is alive with no injury.Image analysis: images were provided for review.The first image is of the devices removable label which matches what¿s reported in the complaint file.The second image appears to be the device loaded in a hoop.The third image is of the distal section of the device.It appears the proximal and mid stent wraps are deformed and bunched distally.Image analysis: eight (8) still fluoroscopic images were provided.The target lesion described as non-tortuous lesion distal to ostium of oblique marginal (om) with 90% stenosis in the middle-left circumflex (lcx) artery at the junction of 1st obtuse marginal (om) with significant perfusion restriction in the middle of the left circumflex (lcx).Images show delivery of procedural wires.Pre-dilation of the target lesion and attempted delivery of a long stent that was not advanced past the left main.Images showing the mechanism of stent deformation were not provided.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

Product analysis summary: the stent was not positioned on the balloon between the marker bands as per position specification, due to proximal and mid-stent deformation the stent did not meet visual acceptance specification.Deformation was evident to the proximal stent segments with struts bunched distally.No deformation was evident to the distal tip.The inner lumen patency was verified with a mandrel.No other damage evident to the remainder of the device.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: STENT, CORONARY, DRUG-ELUTING
• 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: 18628173
• MDR Text Key: 334368318
• Report Number: 9612164-2024-00574
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX22522X
• Device Catalogue Number: RONYX22522X
• Device Lot Number: 0226087906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2023
• 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 Age: 46 YR
• Patient Sex: Male