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

Model Number RONYX30030UX

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/23/2024

Event Type  malfunction  

Event Description

An attempt was made to use one resolute onyx coronary drug eluting stent (des) to treat a non-tortuous, non-calcified lesion located in the mid posterior tibial artery.The device was not inspected.Negative prep was performed with no issues.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that a balloon burst or leak occurred during stent deployment. nominal pressure was applied prior to the burst or leak, but the balloon would not inflate.Two inflations were applied to the device prior to the issue.It is believed that there was a pin size hole in the balloon of the stent.The patient is alive with no injury.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Additional information: the lesion had 10% stenosis.It was later confirmed, that a balloon burst did not occur.However, inflation issues occurred, on the first inflation on the balloon.And the first inflation never reached the minimum pressure. there was only partial inflation of the balloon.The device was not moved or repositioned, while inflated.The same inflation device was successfully used with other devices.The stent was implanted and needed to be post-dilated with another balloon.The patient is alive with no further injury.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank, because the information is currently, unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19210986
• MDR Text Key: 341360187
• Report Number: 9612164-2024-02046
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557024
• UDI-Public: 00643169557024
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX30030UX
• Device Catalogue Number: RONYX30030UX
• Device Lot Number: 0011636538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Date Device Manufactured: 02/14/2023
• 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