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

Model Number	ONYXNG22512UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An attempt was made to use one onyx frontier drug eluting stent to treat a severly calcified lesion with 80% stenosis in the distal obtuse marginal (om).The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated, the device did pass through a previously deployed stent.Resistance was encountered when advancing the device however excessive force was not used during delivery.It was reported that stent dislodgement occurred during delivery to/at lesion.The dislodged stent was not removed.It was stated that wire placement was lost.The family were spoken to with respect to surgery options.The patient is reported to be alive with no injury.
Additional 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.
Additional Manufacturer Narrative
Additional information: a non mdt wire was advanced to the distal om branch for support.Following pre-dilation using a 2.5 x 15 mm balloon the lesion was stented with the 2.5 x 22 non medtronic stent.Because of signicicant residual stenosis just distal to this stent the decision was made to stent this area.Upon advancing a 2.25x22mm onyx frontier drug eluting stent, however upon advancing the stent, the stent detached, from the stent delivery system within the previously placed stent likely after hanging up on calcium.While attempting to advance a balloon catheter over the wire through the dislodged stent, the entire guide catheter system was dislodged from the left main coronary artery.It was stated that wire placement was lost.With significant difficulty, a wire was re-advanced into the distal om branch after re-engagement of the left main coronary artery with a guide catheter.Despite the use of multiple techniques and equipment, a balloon catheter could not pass by the dislodged stent.The dislodged stent did not adhere to the vessel wall.The family did not want to proceed with open heart surgery/bypass grafting, despite the risk of acute stent thrombosis.It was decided to pursue with conservative treatment the decision was made to attempt a right coronary artery (rca) pci.A 6f non medtronic guide catheter without side holes was advanced over a wire and used to selectively cannulate the right coronary artery (rca) a non mdt wire was advanced into the distal rca system for support.Sequential balloon dilatation was performed using a 2.0 x 8 mm and 2.5 x 12 mm balloon with minimal luminal gain due to severe concentric calcification.Intravascular ultrasound was to be performed but the catheter could not be advanced past the severe stenosis of the proximal segment.Additional balloon dilatation was performed without significant luminal gain, an intraluminal coronary lithotripsy was attempted using the shockwave system however the non mdt balloon could not pass the proximal lesion.Multiple attempts were then performed without significant improvement.Due to the length of the procedure and the amount of contrast used, the decision was made to stop the intervention.B1: updated from product problem to adverse event and product problem.H1: updated from malfunction to serious injury 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
• Common Device Name: 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: 15914769
• Report Number: 9612164-2022-04574
• Device Sequence Number: 6798088
• Product Code: NIQ
• UDI-Device Identifier: 00763000511197
• UDI-Public: 00763000511197
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2024
• Device Model Number: ONYXNG22512UX
• Device Catalogue Number: ONYXNG22512UX
• Device Lot Number: 0011067719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/12/2023
• Date Device Manufactured: 02/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 88 KG