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

Model Number	RONYX22512UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure, an attempt was made to use two resolute onyx rx coronary drug eluting stents to treat severely tortuous, non-calcified lesions exhibiting 90% stenosis located proximal and in the ostium of the obtuse marginal 1(om) and left circumflex (lcx) artery.The devices did pass through a previously deployed stent.Excessive force was not used during delivery.It was stated that the first resolute onyx (2.25x12mm, lot 0010812652) was successfully implanted and deployed at 12 atm for 12 seconds in the om1 proximal lesion with no issues noted.A non-medtronic wire was then advanced into the lcx and the second resolute onyx (2.25x12mm, lot 0010920874) stent was advanced onto the wire.It was reported that the stent came off the delivery system and balloon before positioning and deployment.It was stated that the stent dislodged into the vessel undeployed.Multiple attempts were made to oppose the stent using a non-medtronic wire and balloon, but attempts made were unsuccessful.The patient underwent cabg.Post ptca angiogram confirmed reduction in the stenosis from 90% to 0% in the om.The patient is alive with no further injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds remained intact.No deformation evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.Additional information: the first resolute onyx which was successfully implanted and deployed at 12 atm for 12 seconds in the om1 proximal lesion with no issues noted has a lot number of 0010920874.The second resolute onyx stent which dislodged has a lot number of 0010812652.The lot number of the stent is 0010812652 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: 14084248
• Report Number: 9612164-2022-01415
• Device Sequence Number: 2096097
• Product Code: NIQ
• UDI-Device Identifier: 00643169556706
• UDI-Public: 00643169556706
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 07/13/2022

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: 08/19/2024
• Device Model Number: RONYX22512UX
• Device Catalogue Number: RONYX22512UX
• Device Lot Number: 0010812652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 07/13/2022
• Date Device Manufactured: 08/20/2021
• 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 Age: 32 YR
• Patient Sex: Male