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

Catalog Number RONYX35030X

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A resolute onyx 3.50x30mm was intended to treat a mildly tortuous and mildly calcified lesion in the proximal lad.It was reported that there was no damage noted to the packaging and no issues were identified when removing the device from the hoop.The device was inspected with no issues noted.The device was not kinked and re-straightened during the use.It was reported that the lesion was pre-dilated.The resolute onyx device did not pass through a previously deployed stent, resistance was not encountered when advancing the device and no excessive force was used.It was reported that the stent was fractured while pulling back the balloon after the inflation was complete.No attempts were made to remove the resolute onyx stent as it was already inflated.The patient is alive with no injury.

Manufacturer Narrative

Additional information: the lesion had 80% stenosis with thrombus.Negative prep was not performed.The device cracked.The balloon was fully deflated when pulling it back.Intervention was required.A non-medtronic des was implanted overlapping the fractured resolute onyx stent to secure it within the vessel.No damage was noted to the balloon catheter.Age, weight and past medical history updated.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.

Manufacturer Narrative

Additional information: the procedural images provided show a mildly tortuous and mildly calcified lesion in the proximal lad with 80% stenosis.The images confirm the presence of thrombus in the vessel.The images do not capture the pre-dilation of the lesion.A stent which appears to be the complaint device is delivered and deployed in the lesion site.The images show that the stent experienced difficulty expanding in the mid-section when initially pressurized.The lesion appeared to show a focal point of calcification that most likely impacted on full concentric balloon and stent expansion.The deflation of the balloon and the balloon withdrawal is not captured on the images.But images of the stent post balloon removal show that the mid-section of the stent, where the expansion issues appear to have previously occurred, is distorted.Confirming what has been reported from the account.It is not possible to confirm any stent material fracture from the images, but the images appear to confirm that previously adjacent stent wire wraps that are only welded (by design) at certain points on the wire have been separated and distorted due to the forces exerted on them by the balloon removal difficulties and or the calcification in the vessel.Post-dilation of the stent is carried out.Another stent is delivered into the first stent and deployed in order to provide greater stability within the lesion.Further post-dilations are captured in the images.The final images show good blood flow through the vessel after treatment of the lesion.Annex a, annex b, annex c, annex d codes added correction: adverse event and product problem selected (b1) 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

This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4).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
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 12150048
• MDR Text Key: 261003574
• Report Number: 9612164-2021-02696
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Catalogue Number: RONYX35030X
• Device Lot Number: 0010436941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/12/2021
• Supplement Dates Manufacturer Received: 09/27/2021; 11/18/2021; 01/24/2024
• Supplement Dates FDA Received: 10/26/2021; 12/09/2021; 01/24/2024
• Date Device Manufactured: 10/30/2020
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 62 KG