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

Model Number TSTAR40008X

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Deformation (2976)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Please note that this device (onyx trustar) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (onyx frontier).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 onyx trustar coronary drug eluting stent to treat a lesion.The device was inspected with no issues.Negative prep was not performed.Excessive force was not used during delivery.It was reported that inflation difficulties occurred during balloon inflation.No patient injury reported.

Manufacturer Narrative

Additional information: the lesion was pre-dilated.There was zero inflation of the balloon.The stent was not implanted.A new medtronic stent was placed with no issues noted.No patient injury reported.Image review: two still images were received from the account for analysis.Image one shows the back of a shelf carton of an onyx trustar, the size and lot number can be confirmed from the image.Lot number 0011655903, size 4.0mm x 8mm.A section of the hypotube of the device is also visible in the image.Image two shows the transition shaft and guidewire entry port of the device.The guidewire entry port appears stretched.E.Initial reporter: initial reporters phone number 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: a kink was evident on the hypotube.The device returned with balloon folds intact and stent present.No evidence of necking on the proximal balloon bond / distal inflation lumen.Visual inspection confirmed a tear to the exchange joint, continuing along the distal shaft.The balloon failed negative prep due to the tear.On pressurization of the device, liquid was observed exiting the location of the tear, and the balloon failed to inflate.No deformation evident to the stent or other deformation 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: ONYX TRUSTAR
• 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: 18874535
• MDR Text Key: 337354942
• Report Number: 9612164-2024-01199
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TSTAR40008X
• Device Catalogue Number: TSTAR40008X
• Device Lot Number: 0011655903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2023
• 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