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

Model Number	RONYX35008UX
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	06/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent, one cougar guidewire and one 6f launcher guide catheter to treat a non- tortuous lesion in the proximal lm artery.The devices were inspected with no issues noted.Negative prep was performed with no issues noted.The cougar and the launcher were prepped per (b)(4) with no issues.The cougar wire tip was formed.Negative prep was performed with no issues.The resolute onyx and launcher did not pass through a previously-deployed stent.The cougar device did pass through the deployed resolute onyx.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that a launcher was used with a non medtronic guidewire to deliver the resolute onyx to the left main.After the procedure was completed and wire was removed another angiogram was taken.A non medtronic oct device was used to image the stent.Using the launcher guide catheter, the cougar wire was used to cross the newly implanted stent.No issues were noted.The deployed resolute onyx was crossed with a non medtronic oct imaging catheter.Some resistance was noted and difficulties were experienced removing the non medtronic oct catheter.Some effort was applied and the oct device with the cougar wire came back into the aorta along with the newly implanted resolute onyx stent.The angiography showed the stent floating in the aorta.An attempt was made to retrieve the stent with a snare, however the stent could not be located.Another stent was place.The patient is reported to be alive with no injury.
Additional Manufacturer Narrative
Additional information: the cougar device was not used with other devices prior to difficulties occurring.The non-medtronic oct catheter was standard size.It was stated that there was no issue with the launcher guide catheter.Correction: annex a code added 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
Add ime and fdc codes.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: RESOLUTE ONYX RX
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12092852
• Report Number: 9612164-2021-02547
• Device Sequence Number: 3877546
• Product Code: NIQ
• UDI-Device Identifier: 00643169557055
• UDI-Public: 00643169557055
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2021

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: 07/02/2022
• Device Model Number: RONYX35008UX
• Device Catalogue Number: RONYX35008UX
• Device Lot Number: 0010296278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 06/30/2021; 10/13/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/15/2021; 10/26/2021
• 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: 69 YR