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

Model Number TRCR35018X

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Leak/Splash (1354); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

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).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 an onyx trucor coronary drug eluting stent to treat a lesion in the mid left main (lm) coronary artery.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.It was reported that inflation difficulties were encountered during stent deployment, and a balloon burst occurred during stent deployment.There was 12 atm of inflation pressure applied to the balloon prior to the inflation difficulties/burst, and the issues occurred on the first inflation.It was detailed that the stent was properly positioned, and when inflation was attempted nothing happened.The inflation pump was exchanged; however, the second try with the new inflator didn't make any difference.It was decided to retrieve the stent system from the vessel.The stent dislocated from the balloon during the retrieval of the system from the lm to the guide catheter.The stent remains implanted.The patient is alive with no injury.

Manufacturer Narrative

Additional information: event date updated.Annex d code added.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.

Manufacturer Narrative

Product analysis summary: the device returned with balloon folds expanded and contrast visible in the balloon.Crimp impressions were visible on the balloon surface.No evidence of necking on the proximal balloon bond / distal inflation lumen.The balloon failed negative prep.On pressurization of the device, liquid was observed exiting the distal shaft and the balloon failed to maintain pressure.Upon visual inspection of the device, a short longitudinal tear with scratches was observed on the distal shaft.No other damage evident to the remainder of the device.Procedural image review: images confirm the presence of diffuse disease in the left and right coronary systems.The proximal lad and mid lcx lesions were evident with contrast injection.The proximal lad lesion was pre-dilated.This was followed by stent delivery.There was approximately a 5 minute gap in the time clock, and this suggests that the inflation and dislodgement occurred during that time frame.Subsequent images show that the stent has been deployed across the proximal lad and the left main.The proximal end of the stent is not fully expanded initially, and this is most likely due to the deployment balloon not being centrally positioned within the stent when inflated.The deployed stent was successfully post dilated.The cause for the inflation difficulties cannot be determined from the fluoroscopic images provided.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.

Manufacturer Narrative

Additional information: there was no resistance noted during withdrawal of the device and excessive force was not used.There was zero inflation of the balloon.The stent remains implanted but not in the area of the lesion.The device was not moved or repositioned in the lesion while inflated.The same inflation device was used successfully with other devices.Patient age, weight, gender and sex provided.Patient medical history provided.Initial reporter phone number 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: 18736857
• MDR Text Key: 336768853
• Report Number: 9612164-2024-00846
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRCR35018X
• Device Catalogue Number: TRCR35018X
• Device Lot Number: 0012036089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2023
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 58 KG