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

Model Number ONYXNG25022UX

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Vascular Dissection (3160); Insufficient Information (4580)

Event Date 01/29/2024

Event Type  Injury  

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 Description

An attempt was made to use one onyx frontier coronary drug eluting stent to treat a severely tortuous, moderately calcified lesion with 95% stenosis in the distal right coronary artery (rca).The device was not inspected.Negative prep was not performed.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 stent dislodgement occurred during removal following a failed delivery. the dislodged stent was not removed.It was detailed that the stent would not cross the distal rca lesion after significant pre-dilation.Upon retrieval of the undeployed stent, the stent became stuck in the mid rca and would not retract any further.It was noted that the stent was beginning to partially slide off the balloon.Before the stent dislodged fully from the balloon, the balloon was placed inside the stent and the stent was deployed safely.The stent was post dilated with a 3.5mm nc balloon.Another stent was not advanced to the distal area since the vessel had timi3 flow.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: patient information section 3a and 3b updated.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.

Manufacturer Narrative

Additional information: resistance was not encountered during withdrawal of the delivery system.Correction: patient's gender and sex 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: the patient presented to hospital and was sent to the cath lab with worsening angina and typical anginal chest pain.The proximal to mid rca had 80% stenosis and the right posterior descending artery (rpda) was 100% chronically occluded.A right radial approach was used.There was significant aortic tortuosity, making guide engagement difficult.Multiple launcher guide catheters were attempted and used.The ostial, proximal, and mid-distal lesions were very difficult to advance balloons across, even with a guide extension catheter.All lesion were adequately dilated with 2.25mm and 2.5mm nc balloons at high pressure.Upon retrieval of the undeployed stent, the stent became stuck on the proximal lesion in the rca and would not retract any further.The stent was deployed where it was.The stent was post dilated with a 3.5mm nc balloon at 16 atm with good expansion.The distal section had focal non-flow limiting dissection.The procedure was stopped.The lesion had 20mm of its length treated, with 0% residual stenosis post intervention.There was multiple other medtronic devices used during the procedure including cougar guidewire, euphora, and nc euphora balloons.The p atient was discharged home.Section a.Patient information and b7.Relevant history updated.Lot number provided.Facility details updated.Image analysis: initial images show contrast injection into the left coronary system.The initial images of contrast injection into the rca confirms the diffuse disease through out the vessel.The vessel undergoes multiple pre-dilation throughout the vessel.The introduction of a stent can be seen from the proximal vessel to the mid-vessel.The stent did not progress further than the mid vessel and it was deployed in the proximal to mid rca.The proximal end of the stent closest to the tip of the guide catheter was post dilated with a short balloon.Diffuse disease can still be seen in the rca post treatment but no further treatment was completed.Stent dislodgement is not confirmed from the images.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: it is unknown what caused the dissection, or if any of the medtronic devices used caused or contributed.There was no issues or complaint with the other medtronic devices used.Correction: the 2.25mm nc balloon used for pre-dilation was a non-medtronic device.The 2.5mm nc balloon used for pre-dilation was a medtronic nc euphora device.The 3.5mm nc balloon used for post-dilation of the stent was a medtronic nc euphora 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 FRONTIER
• 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: 18737024
• MDR Text Key: 335703599
• Report Number: 9612164-2024-00848
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511319
• UDI-Public: 00763000511319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/02/2024

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG25022UX
• Device Catalogue Number: ONYXNG25022UX
• Device Lot Number: 0011924913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2024
• Date Device Manufactured: 08/25/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 54 KG