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

Model Number	ONYXNG20022UX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
An attempt was made to use one 2.00 x 22mm onyx frontier drug eluting stent to treat a moderately tortuous, mildly calcified lesion with 80% stenosis in the distal left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.Excessive force was not used during delivery.The device was not kinked and re-straightened during use.It was reported that the device detached mid-shaft during advancement through the guide catheter.The overall case was described as challenging, the patient's bp (blood pressure) and o2 (oxygen) were problematic from early in the procedure.A 2.50 x 34mm onyx frontier was implanted in the mid-section of the lad and the 2.00 x 22mm onyx frontier was to be placed in the distal segment.Resistance was encountered when inserting the delivery system through the guide catheter so it was decided to remove the system prior to reaching the distal end of the catheter.Upon removal it was noted that the stent delivery system was in two pieces, a proximal portion and a distal portion.The patient is alive with no injury.
Additional Manufacturer Narrative
Additional information: the onyx frontier was being inserted through a launcher guide catheter.The stent failed to exit the distal end of the launcher guide catheter.The stent and guide catheter were removed as an entire system.The stent balloon was not inflated at the time of the event.Resistance was not noted during withdrawal of the device.The launcher guide catheter was examined and prepped before use as normal and nothing appeared outstanding.There is no complaint or issues with the 2.50 x 34mm onyx frontier device.The launcher device did not malfunction.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.
Additional Manufacturer Narrative
Product analysis: the device was received for analysis.A kink was evident on the hypotube.The device returned with a detachment on the hypotube.Kinks were evident on the hypotube distal to the detachment site.The hypotube material was oval and jagged on both sides of the detachment site.A kink was evident on the inner member distal to the proximal marker band.Misalignment was evident to the proximal stent wraps with struts bent.No deformation evident to the distal tip.No other damage evident to the remainder of the device.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.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 FRONTIER
• Common Device Name: 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: 16773103
• Report Number: 9612164-2023-01672
• Device Sequence Number: 15049565
• Product Code: NIQ
• UDI-Device Identifier: 00763000511159
• UDI-Public: 00763000511159
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2024
• Device Model Number: ONYXNG20022UX
• Device Catalogue Number: ONYXNG20022UX
• Device Lot Number: 0011232817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 05/18/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/11/2023; 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male