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

Model Number RONYX25015X

Device Problems Inflation Problem (1310); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2023

Event Type  malfunction  

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

One resolute onyx rx coronary drug eluting stent (des) was used during an intra cranial atherosclerotic disease (icad) preclinical animal study (porcine model yorkshire breed).The purpose of the study is to evaluate the local, downstream and systemic pharmacokinetics following treatment with the resolute onyx coronary des system in a porcine model.An overstretch model was targeted with a balloon-artery ratio between 1.10:1 ¿ 1.15:1 (10-15% overstretch).The vessel being treated was the ascending pharyngeal artery (apa), there was no calcification, tortuosity or stenosis.The stent delivery system was being developed to treat icad.No issues noted during preparation of the device.Negative prep was prepared with no issues noted.The same inflation device was used successfully with other devices.No resistance was noted while advancing the device to the vessel.No irregularities were noted prior to stent deployment.It was reported that inflation difficulties and stent malapposition issues were encountered during the procedure.It was detailed that the vessel measurements were an average of 2.13 mm (minimum 1.9 mm and maximum 2.35 mm).During the deployment of the 2.5 x 15 resolute onyx stent movement was observed post 9 atm.The stent didn¿t have a wall apposition post deployment at 9 atm for 10%calculated overstretched.The balloon looked completely inflated at 9 atm the balloon pressure was increased to 11 atm (17% calculated overstretch), but the stent still didn¿t have wall apposition.The balloon was then increased to 14 atm (22% calculated overstretch).The balloon was deflated with a vacuum for ~10 seconds.However, the stent still had poor apposition, and appeared to move upon balloon retraction.The pressure was increased 18 atm (27% calculated overstretch).The balloon was deflated with a vacuum for ~10 seconds.The stent still had poor apposition and appeared to move upon balloon retraction.The pressure was increased to 19 atm (29% calculated overstretch).At this stage, the stent was opposed to the vessel wall and did not move post deflation of the balloon.The balloon was not examined post deployment.It is believed that the balloon and stent may have stuck together, thus preventing the balloon successfully deploying the stent at suitable lower pressures.Another sent was successfully implanted instead.

Manufacturer Narrative

Product analysis: the device was returned for analysis.A sheath and stylette were loaded in the device and were removed with no issue noted.The stent was not present on the balloon.The device returned with balloon folds expanded.No evidence of necking on the proximal balloon bond and distal inflation lumen.The balloon passed negative prep.The balloon was inflated to a nominal of 12 atm and an rbp of 18 atm and maintained pressure.Balloon od was measured at 12atm.Measurements were within specification.No other deformation was evident to the remainder of the device.Correction: another stent was successfully deployed next to the first stent, and the balloon was delivered and retrieved with no problems.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

Additional information: annex d 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.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: 17754054
• MDR Text Key: 323476070
• Report Number: 9612164-2023-04191
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX25015X
• Device Catalogue Number: RONYX25015X
• Device Lot Number: 0011704069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2022
• 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