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

Model Number TRCR30038X

Device Problems Material Deformation (2976); Positioning Problem (3009)

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

Event Date 02/14/2024

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

An attempt was made to use one onyx trucor coronary drug eluting stent to treat a lesion.It was reported that stent deformation occurred in vivo during positioning/advancement. it was stated that the stent couldn't pass through the lesion.No patient injury reported.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

Additional information: the lesion had 30% calcification, with 20 degrees of tortuosity and 95% stenosis, located in the right coronary artery (rca).The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered while advancing the device.Excessive force was not used.The device was replaced with another medtronic device of the same size.Patient information added to section a.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: ONYX TRUCOR
• 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: 18999817
• MDR Text Key: 338933170
• Report Number: 9612164-2024-01494
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRCR30038X
• Device Catalogue Number: TRCR30038X
• Device Lot Number: 0011993601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Date Device Manufactured: 10/13/2023
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 73 KG