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

Model Number	ONYXNG40034UX
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	11/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented with a st segment elevation myocardial infarction (stemi).An attempt was made to use one onyx frontier coronary drug eluting stent to treat a lesion in the right coronary artery (rca).It was reported that stent dislodgment occurred in vivo.It was detailed that a stent was successfully deployed in the rca.When a second stent, the onyx frontier stent was being placed, the stent was stripped from the delivery system but remained on the coronary wire.The dislodged stent was moved to the radial artery however, it could not be removed through the radial sheath.Vascular surgery was contacted and the patient was taken for surgical removal of the stent. it was noted that the patient was hemodynamically stable when coming out of the operating room.No further patient injury was reported.
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.
Additional Manufacturer Narrative
Additional information: the device had passed through the previously deployed stent.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
Additional information: procedural images were provided showing the left and right coronary systems with contrast injection.The right coronary system images show pre-dilation of the proximal vessel, followed by deployment what appears to be the 4.0x26mm onyx frontier stent.The attempted delivery and dislodgment of the 4.00x34mm stent does not appear to be captured on the images.Therefore, the root cause of the dislodgement cannot be confirmed from the images.The final images confirm the presence of a dislodged stent on the procedural wire in the radial artery, that is being manipulated by the user.This was most likely during attempts to remove the stent.The stent appears folded over within the vessel, most likely the reason for the failure to remove from the artery during the pci.Annex d code added.Correction: annex a 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.
Additional Manufacturer Narrative
Additional information: the device was inspected before use with no issues noted.The device was prepped per ifu with no issues noted.The lesion was pre-dilated.Excessive force was used.Resistance was noted during withdrawal of the device, the stent would not re-enter the guide during retraction or upon pulling it out of the rca.Excessive force was used.A 1.0x10mm non-mdt balloon was used to pin it against the edge of the guide.Subsequently the entire system, the guide, stent and the balloon was retracted into the radial artery.The dislodged stent caught on the edge of the radial sheath.The stent was successfully snared with a 3.2fr non-mdt catheter however the stent was too deformed to be removed percutaneously through the 6f radial sheath.A 4.0x26 onyx frontier was successfully deployed in the rca with no issues noted.Lesion details - lesion was significantly occluded.Clarification of physician's name.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
Additional information: it was detailed that the 4.0x26mm onyx frontier stent was successfully deployed in the rca, with no issues.The first 4.0 x 26mm onyx frontier stent implanted was not believed to have caused or contributed to the dislodgment of the the 4.00 x 34mm onyx frontier stent.There was no damage to the first stent as a result of this event.Correction: the stent was removed with no issues in the operating room.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 FRONTIER
• Common Device Name: 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: 18315214
• Report Number: 9612164-2023-05899
• Device Sequence Number: 6784017
• Product Code: NIQ
• UDI-Device Identifier: 00763000511708
• UDI-Public: 00763000511708
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2026
• Device Model Number: ONYXNG40034UX
• Device Catalogue Number: ONYXNG40034UX
• Device Lot Number: 0011602282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 01/07/2024; 02/09/2024; 04/04/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/09/2024; 01/30/2024; 02/28/2024; 04/05/2024
• Date Device Manufactured: 01/21/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown