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

Model Number	RONYX20012UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An attempt was made to use two resolute onyx rx coronary drug eluting stents to treat a lesion.It was reported that both stents dislodged prior to deployment.No patient injury was reported.
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: an attempt was made to use one resolute onyx rx coronary drug eluting stents (pli10 ronyx20022ux) to treat a mildly calcified lesion with no significant tortuosity and 60-70% stenosis, located in the proximal diagonal artery.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected before use.The device was prepped per ifu with no issues.The lesion was pre-dilated.The pre-dilation balloons advanced without difficulty and were inflated.It is possible that the device passed through a previously deployed stent or cell of a stent.Resistance was noted advancing the device.Excessive force was not used.It was reported that stent dislodged occurred prior to deployment when positioning at the lesion.The device was advanced three quarters into the diagonal.The stent was unable to be advanced further and then released off of the stent balloon upon withdrawal.The dislodged stent was not removed from the patient.It was not possible to advance the stent balloon back into the stent.It was not possible to advance a 1.2mm non-medtronic balloon into the undeployed stent and it was not possible to wire alongside the undeployed stent and crush the stent.Ultimately, the left anterior descending (lad) artery was stented across the diagonal.It is suspected that the stent dislodgement was caused by previous lad stent strut interaction with the attempted stent placement into the diagonal artery.Resistance was noted during withdrawal of the device but excessive force was not used.The patient is alive and asymptomatic.Pli20 (ronyx20012ux) has been confirmed as not being used during this procedure and was submitted in error.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
• 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: 15051899
• Report Number: 9612164-2022-02732
• Device Sequence Number: 4783965
• Product Code: NIQ
• UDI-Device Identifier: 00643169556638
• UDI-Public: 00643169556638
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2025
• Device Model Number: RONYX20012UX
• Device Catalogue Number: RONYX20012UX
• Device Lot Number: 0011074476
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 08/16/2022
• Date Device Manufactured: 02/16/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown