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

Catalog Number RONYX35026X

Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923); Material Deformation (2976); Positioning Problem (3009)

Patient Problems Sepsis (2067); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 05/13/2023

Event Type  Death  

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 Description

An attempt was made to use on resolute onyx coronary drug eluting stent to treat a non-tortuous, non-calcified lesion in the left main (lm) coronary artery.The device was inspected with no issues.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.It was reported that stent deformation occurred in vivo during positioning/advancement.Then stent dislodgement occurred during removal following the failed delivery.The dislodged stent was not removed.Stent malapposition was also reported.The procedure was completed.The patient deceased.The cause of death and circumstances surrounding the death was reported as sepsis.

Manufacturer Narrative

Additional information: the patient presented to the hospital with a pre-existing gastrointestinal issue and the decision to treat the patients left main artery was made due to a routine cardiac test at the hospital.It was a multiple stenting procedure.Stent dislodgement occurred after positioning the stent at the lesion.There was no non-medtronic device interaction which led to the dislodgement.Attempts were made to deploy the stent after the stent dislodged.No intervention was attempted to retrieve the dislodged stent.Stent deployment issues were experienced.The stent was inflated 3 times at nominal pressure.The stent delivery system was removed.Two non-medtronic sc balloons were used to post dilated the stent, however the stent would not fully appose to the vessel wall.The stent appeared to be elongated and not apposed.Longitudinal stent elongation which was confirmed through optical coherence tomography during the attempt made to inflate during repositioning to prevent stent migration.The stent then migrated.The primary and secondary cause of death was multi organ failure.The cause of the sepsis was reported to be pre-disposing cholecystitis.The patient did not have any previous pci procedures.There was no evidence of restenosis and there was no evidence of thrombus.The physician assessed the death as not related to the device.The patient was on dapt at the time of the event left main (lm) coronary artery with 70-80% stenosis.Date of death.Patient age <(>&<)> weight.Correction: annex e code.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.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
• Type of Device: 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: 17132833
• MDR Text Key: 317202203
• Report Number: 9612164-2023-02602
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Catalogue Number: RONYX35026X
• Device Lot Number: 0011129630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Date Device Manufactured: 03/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 58 KG