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

Model Number ONYXNG35012UX

Device Problems Burst Container or Vessel (1074); Entrapment of Device (1212); Inflation Problem (1310); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 06/20/2023

Event Type  Injury  

Event Description

An attempt was made to use one onyx frontier coronary drug eluting stent to treat a severely calcified, non-tortuous lesion with 70% stenosis in the proximal left anterior descending (lad) artery.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did pass through a previously deployed non-medtronic stent, which was implanted in (b)(6) 2021.Resistance was not encountered when advancing the device.Excessive force was not used.It was reported that stent dislodgement occurred during removal following failed delivery.It was also reported that a balloon burst, and removal difficulties occurred.It was detailed that it was decided to remove the undeployed onyx frontier stent as it was too short and a longer stent was intended to be used.Upon attempted removal of the stent delivery system resistance was felt at the distal left main/proximal lad.The stent was still on the balloon, however, it felt as if the device was stuck at the distal left main/proximal lad and removal difficulties occurred.It was decided to inflate the balloon, however, the balloon would not inflate, and it seemed to have been ruptured.The stent dislodged from the delivery balloon.Upon removal of the delivery system the balloon ruptured was noted.The dislodged stent was not removed.The stent was unexpanded and pinned up against the arterial wall using a 4.0 x 33mm non-medtronic stent.A non-compliant balloon was then used to expand the non-medtronic stent.The patient is alive with no further 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.

Manufacturer Narrative

Additional information: resistance was noted during the withdrawal of the device but excessive force was not used.The balloon would not inflate at all.The same inflation device was successfully used with other devices.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

Product analysis: the device returned for analysis.The device returned with a detachment on the hypotube.Kinks were evident on the hypotube proximal and distal to the detachment site.The hypotube material was oval on both sides of the detachment site.The guidewire entry port was torn.The stent was not present on the balloon and did not return for analysis.The balloon folds were partially expanded.Crimp impressions were visible on the exposed balloon surface.The balloon was unable to be pressurized due to the detached luer, however, upon visual inspection of the device, a short longitudinal tear was observed on the balloon material, immediately proximal to the proximal balloon cone.The balloon material was jagged and uneven at the tear site.No deformation evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.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 analysis: procedural images confirm the presence of the target lesion in the lad.A previously deployed stent is deployed in the proximal lad.The vessel immediately distal to the previously deployed stent was pre-dilated for multiple balloon inflations, followed by introduction of an atherectomy device.Further pre-dilation was then completed.A long stent was delivered through the previously deployed stent and was deployed successfully.This stent did not overlap with the previously deployed stent and there was short gap between the stents.A shorter stent was delivered but it was not deployed.Attempts were made to remove the stent.The stent appeared to bunch along the mid-section and the stent appeared to be deformed.The following images showed that the stent had dislodged inside the stent that was previously deployed in the proximal vessel.The dislodged stent was crushed inside the previously deployed stent and a longer stent was delivered and deployed, treating the dislodged stent and the gap between the previously deployed stents.No evidence of balloon bust and detachment was observed on the images.Correction: the pinhole leak was distal to the proximal markerband.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: 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: 17257192
• MDR Text Key: 318384647
• Report Number: 9612164-2023-02984
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Report Date: 11/23/2023

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: ONYXNG35012UX
• Device Catalogue Number: ONYXNG35012UX
• Device Lot Number: 0011640932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 08/01/2023; 08/24/2023; 10/26/2023
• Supplement Dates FDA Received: 08/10/2023; 09/11/2023; 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 90 KG