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

Model Number ONYXNG30038UX

Device Problems Inflation Problem (1310); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 01/03/2023

Event Type  Injury  

Event Description

An attempt was made to use one onyx frontier coronary drug eluting stent to treat a mildly tortuous lesion in the mid left anterior descending (lad) artery.The device was inspected with no issues.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that inflation difficulties were encountered during balloon inflation, and stent dislodgement occurred during removal following failed delivery.It was detailed that the balloon would not inflate to deploy the stent at the lesion.The stent started inflating but balloon expansion was never seen.The inflation devices were changed but the stent was still was not visibly inflating.Upon pulling the stent delivery system out it was noted that the stent had slightly deployed and got caught on the tip of the guide.Everything was attempted to be removed as one system, but the stent would not come out once it got into the radial artery.The stent dislodged in the radial artery upon trying to remove the stent from the body.The stent had to be surgically removed via a cut down.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: the lesion had 80% diffuse disease stenosis.Negative prep was performed on the device prior to use, with no issues noted.The lesion was pre-dilated with a cutting balloon used proximal to the mid segment.The device did not pass through a previously deployed stent or cell of a stent.There was partial inflation of the balloon.The inflation devices used were non-medtronic.Pressure was attempted to go up to 12 atm.The same inflation device was device used successfully with other devices.Upon pulling the stent delivery system out it was noted that the stent had slightly deployed and got caught on the tip of the 3.5 ebu medtronic launcher guide catheter.Resistance was not noted during withdrawal of the device.Product analysis: the device was returned for analysis.The stent delivery system did not return for analysis.The dislodged stent was deformed and stretched.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: images confirm the presence of diffuse disease in the lad.Multiple pre-dilation balloon inflations were performed in the vessel.No images were provided showing the attempted delivery and inflation of a stent device that was withdrawn back into the guide catheter without deployment.Two (2) stents were successfully delivered and deployed in the mid vessel.This was followed by post-dilatation of the newly deployed stent.Images confirm that the stents were deployed within a tortuous portion of the vessel.Final images confirm the stent dislodged in the radial artery and snaring of the stent was attempted but was unsuccessful.Images were provided confirming that the stent was ultimately successfully removed.Surgical instruments were evident in the frames confirming that the stent was removed through surgical cut-down.No images were provided showing any interaction between the stent and the guide catheter.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: 16184284
• MDR Text Key: 307482411
• Report Number: 9612164-2023-00235
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511531
• UDI-Public: 00763000511531
• 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: 03/07/2023

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: ONYXNG30038UX
• Device Catalogue Number: ONYXNG30038UX
• Device Lot Number: 0011466388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 01/23/2023; 02/21/2023
• Supplement Dates FDA Received: 02/17/2023; 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• 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