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

Model Number	RONYX25015UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a tortuous lesion in the proximal circumflex (cx) artery.The lesion was pre-dilated.It was reported that stent dislodgement occurred during delivery to/at lesion.It was detailed that the stent was meant to be deployed in the mid cx, however, the stent became stuck in the cx.A non-medtronic guide extension catheter (gec) was inserted into the tortuous vessel, and the stent was inserted through the gec.It is believed that the non-medtronic gec caused the stent to be dislodged.The stent was found in the proximal circumflex and it was deployed in that location with a balloon.The patient is alive with no further injury.
Additional Manufacturer Narrative
Additional information: an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a mildly calcified, moderately tortuous lesion in the proximal circumflex (cx) artery with 90% stenosis.The device was inspected before use, with no issues noted.The device was prepped as per the ifu, with no issues noted.The device did not pass through a previously deployed stent.It was also noted that the device would not advance to the lesion after 3 attempts.After each attempt, the lesion was predilated with a balloon.On the 4th attempt, a guideliner was used.The resolute onyx stent still would not advance to the lesion even during use with the guideliner.The stent delivery system was then removed from the patient, and upon inspection, the stent was not found on the catheter.It was found in the mid-circumflex.The stent was then deployed with a balloon at that location in order to prevent migration.The balloon used to deploy the stent was not the stent balloon, it was a different non-medtronic balloon.Excessive force was not used.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: 16032561
• Report Number: 9612164-2022-04874
• Device Sequence Number: 17940574
• Product Code: NIQ
• UDI-Device Identifier: 00643169556805
• UDI-Public: 00643169556805
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/31/2023

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: 05/14/2025
• Device Model Number: RONYX25015UX
• Device Catalogue Number: RONYX25015UX
• Device Lot Number: 0011210684
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/31/2023
• Date Device Manufactured: 05/15/2022
• 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