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

Model Number ONYXNG25034X

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Device Embedded In Tissue or Plaque (3165); 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 drug eluting stent to treat a non-tortuous, non-calcified lesion with 75% stenosis in the proximal 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.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the device or component detached, cracked, or fractured.It was detailed that the stent fractured at the tip after deployment and post dilation.The device was not kinked and re-straightened during use.The fracture in the left main (lm) was observed in oct and ivus imaging.It was stated that it was not a complicated case.The detached portion of the device remains in the patient and it was crushed with a 3.5x18mm onyx stent.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: the stent fractured and remained in one piece.The detached portion of the device remains in the patient and it was crushed with a 3.5x18mm resolute onyx stent.The ronyx35018x was used to treat the fracture with no issues noted.It was later reported that the stent tip did not fracture.The stent was elongated and fractured at the proximal part.There was no issues noted during stent deployment.A 3.5mm nc non-medtronic balloon was used to post dilate the stent at 12 atm.It is possible that the post dilation balloon caused or contributed to the stent fracture.The post dilation balloon was dilated within the limits of the post dilation chart.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

Procedural image analysis: fluoroscopy images provided from the account show the target lesion in the proximal lad.The proximal lad vessel is pre-dilated with a long balloon followed by delivery and deployment, without issue, of what appears to be the 34mm onyx frontier stent.The proximal end of the vessel and stent were post dilated with a shorter balloon on multiple occasions.This was followed by ballooning with a longer balloon distal to and within the newly deployed 34mm stent on multiple occasions.An oct/ivs probe was delivered through the lad.Fluoroscopy images after the post dilation and use to the other devices appear to show an irregularity in the profile of the 34mm stent at the proximal end.This was followed with the delivery of an additional dilation balloon that was inflated distal to the 34m stent and within the stent more proximally.It appears that multiple balloon inflations and excessive back and forth access into the vessels through the stent struts, with excessive ballooning, is the plausible scenarios for stent deformation, in that accessory devices did most likely get snagged on the newly deployed stent as multiple passes were performed.The vessel treatment does appear to have been completed in complicated sequences.There was positioning of a proximal stent, followed by post dilation of the left main and proximal stent.Final angiographic review without contrast injection showed the deployed stent profiles.No evidence of deformation or fracture.The fluoroscopy images do not show any angiographic complications and there was no patient impact.Oct image analysis: three oct images were provided.The length of the stent appears longer than 34mm.Based on description of the events of the procedure, there is no expectation that the stent would be distorted as observed, apart from the potential fracture observation on the proximal end of the stent.The proximal end of the stent is elongated, and the most proximal wraps of the stent appear to be distorted off the central axis of the vessel.Typical causes of elongation of a stent post-deployment are due to snagging of a secondary device or the stent delivery system on the stent during retraction.This could potentially cause the distortion from the central axis seen with the most proximal wraps, if the snag occurred on only one edge of the stent.Gaps are present throughout specific regions of the deployed stent.Many instances appear to be missing struts entirely, which would be highly unlikely due to requiring simultaneous fractures on both ends of a strut.Adjacent strut alignment makes fracture a possibility.This may possibly be artefacts of the oct imaging or stent deformation due to snagging of procedural accessories.Instances of gaps where adjacent strut alignment indicates no missing segment of wire do not show unusually high strains making a fracture unlikely.But the images as provided do appear to show wire gaps that could be interpreted as stent fracture.Correction: annex a codes.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: 18675234
• MDR Text Key: 335005188
• Report Number: 9612164-2024-00692
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2024

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
• Device Operator: Health Professional
• Device Model Number: ONYXNG25034X
• Device Catalogue Number: ONYXNG25034X
• Device Lot Number: 0012007721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/12/2024; Not provided
• Supplement Dates FDA Received: 02/21/2024; 05/31/2024
• Date Device Manufactured: 10/24/2023
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG