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

Model Number RONYX40018X

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a non-tortuous, moderately calcified lesion in the distal carotid artery.The device was inspected with no issues noted.Negative prep was performed.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the stent dislodgement occurred during delivery to/at the lesion and the stent failed to cross the lesion was also encountered.It was detailed that the dislodged stent was not removed, it was deployed however it dislodged at distal part due to anomalous plaque at the lesion site.Another stent was implanted to treat the remained gapped lesion between the internal carotid artery (ica) and the dislodged space where plaque was present.The patient was reported alive with no injury.

Manufacturer Narrative

Image review: the images show the presence of two previously deployed stents in the carotid artery.The user is planning to deliver and deploy a stent distal to the more distal stent.A stent is delivered and deployed distal to the more distal stent.The newly deployed and previously deployed stent are not overlapping.There is a small gap between the stents.Subsequent images show that the newly deployed stent has migrated distally in the vessel.The mechanism of movement has not been shown in the video provided.Another stent appears to have been delivered and deployed overlapping with the stents in the vessel, with a good result.There is no evidence of a stent dislodgment.The issue appears to have been stent migration post deployment.The resolute onyx stent is approved for use in the coronary arteries and use in the carotid may have also impacted the result.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: the stent migrated post-deployment.After deployment, the stent dislodged to the distal internal carotid artery (ica).Post-dilation was performed where the stent was positioned.Procedural images were received for analysis.The images show the presence of two previously deployed stents in the carotid artery.The user is planning to deliver and deploy a stent distal to the more distal stent.A stent is delivered and deployed distal to the more distal stent.The newly deployed and previously deployed stent are not overlapping.There is a small gap between the stents.Subsequent images show that the newly deployed stent has migrated distally in the vessel.The mechanism of movement has not been shown in the video provided.Another stent appears to have been delivered and deployed overlapping with the stents in the vessel, with a good result.There is no evidence of a stent dislodgment.The issue appears to have been stent migration post deployment.The resolute onyx stent is approved for use in the coronary arteries and use in the carotid may have also impacted the result.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: RESOLUTE ONYX RX
• 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: 15875986
• MDR Text Key: 307568692
• Report Number: 9612164-2022-04453
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX40018X
• Device Catalogue Number: RONYX40018X
• Device Lot Number: 0011264926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• Date Device Manufactured: 06/15/2022
• 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 Age: 54 YR
• Patient Sex: Male