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

Model Number RONYX30022JX

Device Problem Difficult to Remove (1528)

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

Event Date 01/25/2024

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.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.

Event Description

An attempt was made to use one resolute onyx drug eluting stent (des) to treat a lesion in the left anterior descending (lad) branch (cass#6).The device was inspected with no problems observed.Negative prep was performed with no problems observed.The lesion was pre-dilated with a 2.5x15mm non-medtronic device.There were no issues with the remaining stenosis rate and condition after dilation.The resolute onyx des did not pass through a previously placed stent.There was no resistance/discomfort when the product was delivered.Excessive force was not applied during delivery.It was reported that removal difficulties occurred after stent placement.The resolute onyx wire was stuck.A non-medtronic wire was also in use at the time time of the event.It was detailed that the wires were removed and the procedure was completed without any problems.Post-dilation of the stent was performed.The stent was implanted.The patient is alive with no injury.

Manufacturer Narrative

Additional information: the lesion being treated had 90% stenosis.Difficulty occurred in removing the catheter/delivery system and balloon from the stent.The stent was sufficiently expanded prior to attempting removal of the balloon.Sufficient time was given to allow the balloon to fully deflate prior to attempting removal.After the stent was placed, attempts were made to retrieve the balloon, but there was resistance and the balloon could not be retrieved.On removal of the balloon from the stent, resistance was encountered as the device was retracted over the guidewire.The balloon and the wires were removed.Intervention was not required to remove the catheter/delivery system and balloon from the patient.The stent was not deformed due to the difficulties experienced when removing the balloon.There was no damage noted to the guidewire on removal from the patient.There was no injury to the patient as a result of the event.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: two guidewires returned unloaded in the device for analysis.One medtronic and one non -medtronic guidewire.Both 0.014¿ inch guidewires were backloaded through the distal tip and advanced proximally through the exchange joint with no resistance noted.Both 0.014¿ inch guidewire were frontloaded through the exchange joint and advanced distally through the distal tip with no resistance noted.The inner lumen patency was verified with a 0.015 inch mandrel.The balloon was inflated to 12atms and held pressure with no issues noted.The balloon was deflated to approx.0atms with no issues noted.No other damage evident to the remainder of the device.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: 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: 18686871
• MDR Text Key: 336211324
• Report Number: 9612164-2024-00734
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX30022JX
• Device Catalogue Number: RONYX30022JX
• Device Lot Number: 0011253523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• 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