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

Model Number	ONYXNG20018UX
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One image was provided for review.The image was of the device shelf carton.The lot number 0011007109 and the device details on the label of the shelf carton match what was reported in the complaint file.It was not possible to confirm complaint from still image review.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.
Event or Problem Description
An attempt was made to use one onyx frontier coronary drug eluting stent to treat a moderately tortuous, mildly calcified lesion exhibiting 80-90% stenosis located in the proximal obtuse marginal (om).The device did pass through a previously deployed stent.It was reported that stent embolization occurred.It was stated that a 6 fr 3.5 non-medtronic guide catheter was used and the lesion couldn't be crossed at the distal om.Force was not used.The stent catheter was pulled back and it was noticed that there was no stent on the delivery system.Under a fluoroscopy, the stent was found at the proximal part of the vessel.A 1.5 balloon was used to attempt to deploy the stent however the balloon could not get into it the stent.A 0.014 wire was then advanced and there was an attempt to crush the stent to the vessel wall using a 2.0 balloon, however the balloon did not cross and the stent migrated to the distal part of om vessel. there was an attempt to snare the stent but after manipulating the wire, it was noticed that the tip of the wire got separated and it was floating freely at the most distal part of the vessel.The stent relocated to the proximal part of the vessel again.It was decided to pull back all devices and the access was closed with 6fr angioseal.No further injury was reported.
Additional Manufacturer Narrative
Additional information: the device was inspected before use with no issues.The device was prepped per ifu with no issues.The lesion was pre-dilated.Resistance was noted advancing the device.Excessive force was used.The 1.5 and 2.0 balloons used were both medtronic euphora balloons.Resistance was noted during attempted withdrawal of the stent but excessive force was not used.The dislodged stent was not removed from the patient.It was stated that the 6fr non-medtronic guide extension catheter used at the beginning of the procedure caused the stent to be stripped off the balloon.The patient was kept overnight and had no further complications.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: two videos from the cath lab screens were provided for review.The first image confirms the presence of a moderately tortuous, mildly calcified lesion exhibiting 80-90% stenosis located in the proximal obtuse marginal (om).The lesion was located immediately distal to a previously deployed stent.The second video shows the presence of a dislodged stent immediately distal to the previously deployed stent.The mechanism of dislodgement was not provided on the images.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: 15549043
• Report Number: 9612164-2022-03671
• Device Sequence Number: 19304200
• Product Code: NIQ
• UDI-Device Identifier: 00763000511142
• UDI-Public: 00763000511142
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2022

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: 01/07/2024
• Device Model Number: ONYXNG20018UX
• Device Catalogue Number: ONYXNG20018UX
• Device Lot Number: 0011007109
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 10/09/2022; 11/14/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 10/27/2022; 11/17/2022
• Date Device Manufactured: 01/07/2022
• 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: 76 YR
• Patient Sex: Male