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

Model Number ONYXNG30012UX

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 04/03/2023

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 3.00 x 12mm onyx frontier drug eluting stent (des) to treat a lesion in the proximal right coronary artery (rca).The device was inspected with no issues noted.Negative prep was not performed.Resistance was not encountered when advancing the device.Excessive force was not used during the delivery.It was reported that a stent dislodgement occurred during removal following a failed delivery.It was stated that the 3.00 x 12mm onyx frontier stent was too short and was being removed to implant a longer length stent.The stent became dislodged when it was being pulled back.The dislodged stent went into the aorta.The dislodged stent was not removed and intervention was carried out.The patient is alive with no injury.

Manufacturer Narrative

Additional information: the device was prepped per ifu with no issues noted.Following pre-dilation there was 50% residual stenosis.Resistance was not noted during withdrawal of the device.Excessive force was not used.It was reported that a stent dislodgement occurred during removal following a failed delivery.The stent was intended to cover an ostial dissection believed to be caused by guide placement or orientation of the guide.It was stated that the 3.00 x 12mm onyx frontier stent was too short and was being removed to implant a longer length stent.The stent became dislodged when it was being pulled back into the guide.The guide appeared to strip the stent off the balloon.The dislodged stent went into the aorta and was lost.The stent did not appear in the coronary, the subclavian or the carotid and was not on the wire or in the guide.The patient remained hemodynamically stable with out neurological compromise.The dislodged stent was not removed and intervention was carried out.A new 3.0 x 18 mm onyx frontier stent was placed to cover the proximal vessel and what appeared to be the proximal dissection.The stent was deployed at 14 atm.There was no residual dissection or thrombus and excellent timi grade 3 flow was in the vessel.If clinically warranted a skeletal survey may be performed to determine the location of the stent.Procedural image review: procedural images confirm the presence of a calcified lesion in the proximal rca.The calcification appeared to be focal in the mid lesion.The lesion was pre-dilated.A stent was delivered across the lesion but appears to have been withdrawn as not stent delivery system or deployed stent can be seen in the lesion.It appears that the reported dislodgement occurred during removal of this device.But as stated from the account that the dislodged stent went into the aorta and was lost.The stent did not appear in the coronary, the subclavian or the carotid and was not on the wire or in the guide.A replacement stent that appeared to be longer than the original stent was delivered and deployed successfully across the lesion.Patient medical history and weight provided.Correction: additional codes.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: annex d code.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
• Type of Device: 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: 16816364
• MDR Text Key: 314022199
• Report Number: 9612164-2023-01792
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511463
• UDI-Public: 00763000511463
• 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
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONYXNG30012UX
• Device Catalogue Number: ONYXNG30012UX
• Device Lot Number: 0011584755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 57 KG