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

Model Number ONYXNG35026UX

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2023

Event Type  Injury  

Event Description

An attempt was made to use one onyx frontier coronary drug-eluting stent to treat a calcified lesion in the ostium of the left main (lm) coronary artery. the device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that stent dislodgement occurred during removal following a failed delivery.It was detailed that the stent was advanced through a previously deployed stent in the lm that had already been post-dilated.It was noted that the guide catheter may have become disengaged as the stent was advanced into the lm.The stent failed to be delivered and upon pull back from the lm, the stent dislodged into the aorta. a snare was used to successfully to remove the dislodged stent from the patient.It was noted that this was a complex case with the use of an impella and rotoblade.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 patient presented to hospital with substernal chest pressure and unstable anginal symptoms.The patient had previous cardiac cat heterization that demonstrated moderate to severe left anterior descending (lad) artery stent under-expansion behind areas of heavy calcification, a significant left main (lm)-lad stenosis as well as a significant ramus intermedius stenosis.The patient has stents to the right coronary artery (rca) with moderate stenosis.The patient was therefore presenting for a high-risk lm, lad, ramus intermedius dk crush, with need for rotablation and shockwave lithotripsy.Given the patient's mildly reduced ejection fraction, the decision was made to proceed with hemodynamic support with a 3.5 12f impella cp device.Access was obtained via the right common femoral artery.It was detailed that after placement of the impella device, rotablation of the ramus intermedius, followed by shockwave lithotripsy of the lad and lm was performed.A 3.75 guide catheter was used to intubate the lm.The ramus was wired and rotablation was performed with a des present.After rotablation the lad was wired and lithotripsy was performed from the mid lad, all the way back to the proximal, and then lithotripsy of the lm into the lad was performed for multiple inflations.There were approximately 20 runs with the lithotripsy balloon with two catheters.After lithotripsy stent post-dilation with a 3.5 balloon in the lad stents was performed.It was decided not to re-line the stents as intravascular ultrasound (ivus) was performed which demonstrated no significant in-stent restenosis.This was followed by dk crush stenting technique.A 3.0x12mm medtronic onyx frontier des was used in the ramus intermedius, crushed with a 4.0x26mm medtronic onyx frontier des in the lm into the lad.The lesions were rewired, and kissing dilatation was performed and final proximal optimization technique of the lm with a 4.0 balloon was done.Resistance was noted during the withdrawal of the 3.5x26mm onyx frontier stent , but excessive force was not noted.The guide catheter that may have became disengaged was a medtronic launcher device.It was later reported that as a dk crush technique was used to deploy the other stents, they should have been fine and it is not known what caused the stent to dislodge, angulation is a thought.The final result was excellent with no evidence of thrombus, perforation or dissection.A 4.0x18mm onyx frontier stent was also used during the procedure, as well as the 3.0x12mm and 4.0x26mm onyx frontier stents.There are no complaints against these devices.Patient age, sex and weight provided.Medical history provided.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: ivus images reveals a stenosis within the previously implanted stent ¿ where the vessel size as measured was 2.6mm and further distal in the vessel the size (diameter) is roughly 3.5mm.Calcification is present.There is no evidence of the detached stent in the ivus images.The fluoroscopic images confirm the presence of a balloon pump.The vessels show evidence of calcification and in-stent restenosis of the previously deployed stent.It appears the images provided were post the reported dislodgement of the stent as there are no images showing the attempted unsuccessful delivery of a stent that was being withdrawn when it dislodged.No images provided of the snare attempts.Multiple pre-dilation balloons were introduced followed by the successful delivery and deployment of a long stent, whose profile is impacted by the presence of calcification in the vessel.The stent is not fully concentric throughout.The previously deployed stent and the new stents were post dilated as described with kissing dilatation being performed and final proximal optimization technique of the lm with a 4.0 balloon being completed.The launcher guide catheter can be seen backing out of the ostium of the left main during the procedure, most likely due to difficulty with device positioning and deployment.No images were shown that conclusively confirm the root cause of the stent dislodgement but images do concur with the reports that the anatomy and complexity of the case most likely contributed to the issues experienced.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: it is believed that the stent dislodgement was probably related to the stent being caught on the most distal stent placed.Anatomy and complexity of the case likely contributed.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: 17886364
• MDR Text Key: 325093431
• Report Number: 9612164-2023-04530
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00763000511593
• UDI-Public: 00763000511593
• 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: 12/11/2023

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: ONYXNG35026UX
• Device Catalogue Number: ONYXNG35026UX
• Device Lot Number: 0011777853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/16/2023; 10/26/2023; 11/17/2023
• Supplement Dates FDA Received: 10/17/2023; 11/15/2023; 12/11/2023
• Date Device Manufactured: 05/25/2023
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 57 KG