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

Model Number	RONYX35026UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2021
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
An attempt was made to use a resolute onyx drug eluting stent, a telescope guide extension catheter and a launcher guide catheter in a mildly calcified, mildly tortuous lesion, with 80% stenosis, located in the proximal obtuse marginal (om) artery.The devices were inspected before use with no issues.Negative prep performed was performed on the stent with no issues.The telescope and launcher were prepped per ifu, with no issues.The lesion was not pre-dilated.The resolute onyx stent did not pass through a previously-deployed stent.Resistance was encountered when advancing the resolute onyx.Excessive force was not used.It was reported that stent dislodgement occurred during removal following failed delivery and ended up in the ulnar artery.It was suggested that the stent was deformed as a result of trying to return through the tip of telescope causing the stent to be dislodged from the balloon.The device was removed using a snare.No further injury was reported.
Additional Manufacturer Narrative
Product analysis/image review: cine images were returned for analysis.No images were provided showing the attempted delivery of the stent that was confirmed to have dislodged in the ulnar artery.The mechanism of delivery difficulties or dislodgement cannot be confirmed from the images provided.The nature of deformation on the stent suggests that the stent may have touched off the tip of the guide extension catheter during withdrawal causing flaring and dislodgement from the delivery system.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.

• 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: 12882362
• Report Number: 9612164-2021-04607
• Device Sequence Number: 17118545
• Product Code: NIQ
• UDI-Device Identifier: 00643169557109
• UDI-Public: 00643169557109
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 03/08/2022

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: 10/05/2022
• Device Model Number: RONYX35026UX
• Device Catalogue Number: RONYX35026UX
• Device Lot Number: 0010402417
• 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: 11/19/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2020
• 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: 72 YR
• Patient Sex: Male