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

Model Number TRCR30026X

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

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

Event Date 01/31/2024

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 two 3.0x26mm onyx trucor drug eluting stents (des) to treat a lesion in the left anterior descending (lad) artery.The devices were inspected with no issues noted.Negative prep was performed on the second onyx trucor des with no issues noted.The lesion was pre-dilated with a 2.5x26 mm balloon at 14atm.The devices did not pass through a previously deployed stent.Resistance was encountered when advancing both devices.It was reported that stent dislodgement occurred during delivery of both stents to/at the lesion.It was detailed that lesion of the lad was crossed with a 0.014 non-medtronic guidewire and predilated.An attempt was made to to advance the first onyx trucor des but it got stuck in the guide catheter.When removing it, the stent dislodged from the balloon.The dislodged stent was removed by retracting it since it was inside the guide catheter.An attempt was made to advance the second onyx trucor des however, it too became stuck in the guide catheter.This time the stent was completely dislodged from the balloon so the entire system (guide catheter and coronary guide) were removed.A new guide catheter was advanced and the lad was crossed again.A 2.75x26mm onyx trucor des was implanted at 20atm, achieving a satisfactory result.There was no medical or surgical intervention 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.Please note that this device (onyx trucor) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (resolute onyx rx).

Manufacturer Narrative

Image analysis: one image was received for review.The image appears to show an onyx trucor stent stretched distally over the distal tip.The label information in the image matches what was reported on file.Additional information: the lesion being treated was mildly calcified, mildly tortuous with 80% stenosis.For the first onyx trucor des (0011840354), only the air that was aspirated with a syringe and the device was then connected to the insufflator, without negative pressure.The lesion was pre-dilated with a 2.5x26 mm medtronic balloon with no issues noted.Excessive force was not used.A non-medtronic 3.5 6f guide catheter was used during the procedure.Both stent dislodgments occurred in the guide catheter during advancing.The new guide catheter used was a non-medtronic 3.5 6f device.The 2.75x26mm onyx trucor des was implanted at 20 atm as a diameter of 3.0-3.2mm needed to be acquired but there was no other 3.0mm stent of that length available.Patient gender 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.

• Brand Name: ONYX TRUCOR
• 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: 18720311
• MDR Text Key: 335568817
• Report Number: 9612164-2024-00815
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRCR30026X
• Device Catalogue Number: TRCR30026X
• Device Lot Number: 0011840354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Date Device Manufactured: 06/26/2023
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 105 KG