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

Model Number ONYXNG40022UX

Device Problems Burst Container or Vessel (1074); Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

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 lesion in the proximal left main (lm) coronary artery.The device was inspected prior to use with no issues noted.The lesion was pre-dilated.The patient was under going a transcatheter aortic valve replacement (tavr).It was reported that the onyx frontier catheter detached, cracked, franctured.The stent was deployed however the catheter had broken off and had caused an obstruction.The part that broke off had to be retrieved.No patient injury was reported.

Manufacturer Narrative

Additional information: there was a previous patent 4.0 x 28mm non-medtronic des in the lm.This stent was wide open and was used to protect a leaflet from closing the lm during deployment of a medtronic corevalue tavr device inside a mechanical valve.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The stent was being delivered through a 6fr non-medtronic guide extension catheter, as the corevalve was deployed at 80%.The tavr procedure was performed prior to use of the onyx frontier device.It was reported that the onyx frontier balloon burst, and the catheter detached in vivo.The balloon ruptured circular instead of horizontal, and it was a clean circle.It¿s unknown if the burst caused a full radial tear of the balloon material or if this was initially a partial tear that was then propagated circumferentially when the delivery system was removed.Approximately half of the balloon/stent was external to the coronary when deployed.It was indicated that the balloon burst led to the balloon material snagging on either the tavr frame or less likely calcium at the coronary ostium.This presumed snagging of the distal balloon material led to difficulty removing the stent delivery system.A complete fracture occurred, and the device broke into two separate pieces.The front half of the balloon was left with the marker band at the lm.The yellow segment ended up near the groin in the aorta.The yellow inner membrane fractured somewhere proximal to the distal marker band.A portion of the inner member containing the distal marker band, the tip, and distal portion of the balloon remained in the patient, stuck on the proximal wire.When trying to remove the device the inner membrane was stretched.This caused the device to tighten down onto the guidewire.The inner membrane broke a second time near the exchange joint during removal of the proximal portion of the delivery system, which was attached to the outer shaft and proximal portion of the balloon.This left the majority of the inner member stretched and locked onto the guidewire, which prevented anything else getting across this wire.The catheter was removed but the yellow sleeve was missing which was stuck on the proximal wire and really stretched.Intervention was required to remove the device.The detached portion of the catheter was removed from the patient; however, a portion of the stent balloon and marker band still remains in the patients lm artery.The patient is stable and has been discharged.There is no complaint against the medtronic corevalve device used during the procedure.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

Image review: multiple procedural images were provided for review.The images confirm the presence of a previously deployed stent in the left main.The corevalve was partially deployed across the aortic valve.The onyx frontier stent appears to be delivered to the distal end of the previously deployed stent.The attempted stent deployment and the balloon burst cannot be accurately determined from the images provided.But it appears most likely that the sharp angulation at the end of the previously deployed stent in the lm impacted on deployment difficulties.But the exact rot cause cannot be confirmed from the images provided.The balloon material may have caught on the previously deployed stent resulted in damage to the stent delivery catheter.But this cannot be confirmed.Image review: photos of the burst and detached device were provided from the account, along with a schematic diagram of the vasculature in which the deice was used.The photos confirm that the distal end of the inflation lumen appears to have expanded and to have burst with a full radial (circular) failure mode.The schematic images match the procedural fluoroscopic images provided from the account.The distal inner and transition shafts are extremely stretched and necked.Product analysis: the device was received for analysis.The proximal section of the delivery system returned with a section of outer shaft still attached.Distal of the exchange joint, there was a detachment of the inner member.The material was jagged and uneven at the inner detachment site.A clean cut to the outer shaft was evident, approx.21cm distal to the exchange joint.The material distal of the cut was not available for analysis.The detached inner member was loaded entrapped on the 0.014¿ non-medtronic guidewire.A non-medtronic haemostasis valve also present on the guidewire.The detached inner measered approx 50cm.Bunching and stretching evident along the length of the detached inner member.Both ends of the inner member material was jagged and uneven.On the distal end of the inner member there was further deformation, with cuts, scratches and marks noted.The marker bands were not on the returned inner member and did not return for analysis.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: 15913398
• MDR Text Key: 306927191
• Report Number: 9612164-2022-04556
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511678
• UDI-Public: 00763000511678
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2023

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: ONYXNG40022UX
• Device Catalogue Number: ONYXNG40022UX
• Device Lot Number: 0011279889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/07/2022; 01/10/2023
• Supplement Dates FDA Received: 12/21/2022; 02/08/2023
• Date Device Manufactured: 06/24/2022
• 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