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

Catalog Number RONYX27522X

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Stenosis (2263); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 11/20/2022

Event Type  Injury  

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.

Event Description

During the index procedure four resolute onyx drug eluting stents were implanted in the distal and proximal right coronary artery.During the procedure three euphora balloons were also used for pre-dilation and seven nc euphora balloons were used for post-dilation.Approximately 6 days post procedure the patient presented with severe chest pain and st elevation.Stent thrombosis was confirmed by angio and occurred in the resolute onyx drug eluting stent.It was stated that there was a mechanism of stent failure as severe stent under expansion had occurred in this stent.The stent was re-expanded.In stent restenosis was also noted.The event was treated with a percutaneous coronary intervention during which one euphora balloon and two nc euphora balloons were used to treat the distal rca.It was stated that this was a clinically driven target lesion revascularization.The patient recovered.The patient was taking dual antiplatelet therapy within 24 hours prior to the event.The investigator assessed the event as possibly related to the device and not related to the procedure.The sponsor assessed the event as possibly related to the device and procedure.

Manufacturer Narrative

Additional information: the resolute onyx device was inspected before use with no issues noted.Resistance was noted while advancing the device to the lesion.Excessive force was used during delivery.Stent thrombosis was confirmed by angio and occurred in the resolute onyx drug eluting stent located in the distal rca (lot number 0 011036519).The stent was re-expanded with a balloon.Two 2.75 nc euphora balloons were used to treat the distal rca.There were no issues noted during post-dilation of the stent.In-stent restenosis did not occur in any of the other three implanted resolute onyx stents.There were no issues or complaints with any of the euphora or nc euphora balloons used in any of the procedures.The investigator assessed the event as causally related to the procedure.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.

Manufacturer Narrative

Correction: during the procedure in total, three euphora balloons and three nc euphora balloons were used for pre-dilation.Four nc euphora balloons were used for post-dilation.A 2.75 nc euphora balloon had been used to post-dilate the 2.75 x 22mm resolute onyx stent in the index procedure, and no issues were noted during post-dilation.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.

Manufacturer Narrative

Image analysis: procedural images provided for the index procedure on the 14th nov 2022 showed that the patient had undergone cabg to the lad.The rca is confirmed to be diffusely diseased throughout the vessel.The vessel appears fibrotic and calcified.There was difficulty experienced delivering the procedural wire to the distal vessel.After unsuccessful balloon delivery the entire vessel was treated with multiple runs of a rotational atherectomy device.This was followed by balloon pre-dilation and further rotational atherectomy.The vessel treatment was supported with use for a guide extension catheter, confirming the difficult nature of the vessel treatment.The distal vessel stent was delivered and deployed.Irregular distal stent deployed profile can be seen that appears to be impacted by the fibrotic/calcified nature of the lesion.Deployment of the most distal stent was followed by the deployment of a stent overlapping on the proximal end of the most distally deployed stent.The second stent deployed was post dilated.This was followed by delivery and deployment of a mid-vessel stent and a proximal vessel stent.The vessel appears fully patent and the only issue appears to be the impact of the vessel morphology in the full expansion of the most distal stent.No images were provided of the treatment and the adverse events reported six days post the index procedure.But it appears most likely that the lesion morphology impacted on the full expansion of the distal stent and this contributed to the adverse events.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: 16960842
• MDR Text Key: 315541488
• Report Number: 9612164-2023-02123
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2024
• Device Catalogue Number: RONYX27522X
• Device Lot Number: 0011036519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Date Device Manufactured: 01/25/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 93 KG