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

Model Number ONYXNG27530UX

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2024

Event Type  Injury  

Event Description

An attempt was made to use one onyx frontier coronary drug eluting stent to treat a moderately tortuous, moderately calcified lesion with 100% chronic total occlusion (cto), located in the distal circumflex (cx) artery.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used.It was reported that stent dislodgement occurred during removal following a failed delivery.An attempt was made to deploy the stent distal to two previously deployed stents in the proximal and ostial cx artery.As the stent was advanced resistance was met in the previously deployed stents.The stent was then attempted to be pulled back; however, this was unsuccessful.The catheter was cut and a non-medtronic guide extension catheter was used in an attempt to retrieve the stent.The delivery system was then removed; however, the stent was still caught in the ostial cx.A gooseneck snare was used to remove the dislodged stent.The patient is alive with no further injury.

Manufacturer Narrative

Image analysis: nine still images were received from for review.Image one and two show the user holding the distal section of a guide catheter.A stent can be seen at the opening of the guide catheter.The stent is dislodged from the device and is grossly deformed.Stretching is evident to the stent.Image three shows the stent from a different orientation.The stent is dislodged from the device and is grossly deformed.Stretching is evident to the stent.The fourth and fifth images show a close-up of the stent.Blood is evident on the stent.Gross deformation is evident to the stent, struts are raised and stretched in this image.Images six, seven, eight and nine show the device in a biohazard bag.The stent is at the distal section of the guide catheter.Blood is visible on the bag.Gross deformation is evident to the stent, struts are raised and stretched in this image.Product analysis : the device was returned to medtronic for analysis.A kink was evident to the hypo-tube.The device returned with a non-medtronic guide catheter and snare.The luer was detached from the device and did not return for analysis.The hypo-tube material was smooth and even at the detachment site, characteristic of a cut to the tubing.The stent was not present on the balloon but returned attached to a snare.Gross deformation was evident to the stent.The balloon folds were intact.Crimp impressions were visible on the exposed balloon surface.The inner lumen patency was verified with a 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

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 two previously deployed stents were non medtronic devices.There were no issues noted with the two previously deployed stents prior to the use of the resolute onyx stent or following the dislodgement and removal of the resolute onyx stent.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: 18606605
• MDR Text Key: 334099255
• Report Number: 9612164-2024-00503
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511425
• UDI-Public: 00763000511425
• 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: 02/28/2024

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: ONYXNG27530UX
• Device Catalogue Number: ONYXNG27530UX
• Device Lot Number: 0011308255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 02/26/2024
• Supplement Dates FDA Received: 02/14/2024; 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male