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

Model Number	RONYX40015UX
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Arrhythmia (1721); Insufficient Information (4580)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An attempt was made to use one resolute onyx coronary drug eluting stent to treat a non-tortuous, non-calcified lesion in the proximal right coronary artery (rca).The device was not inspected.Negative prep was performed 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 a balloon burst/leak occurred during stent deployment.The stent catheter was put in position and when an attempt was made to inflate the device no pressure showed on the inflation device.The inflation device was continued to be rotated but there was no pressure going into the balloon, and the stent was not expanding.Contrast was seen jetting back into the aorta and it was believed that the balloon had ruptured.The issue occurred on the first inflation.A total of 30cc of contrast was injected to expand the stent enough to be able to remove the stent delivery system and go back in with an nc balloon.The patient experienced st's however remains stable.The patient is alive with no further injury.
Additional 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.
Additional Manufacturer Narrative
Additional information: the stent was successfully implanted with the nc balloon.The patient did not require any treatment for the sts experienced.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.
Additional Manufacturer Narrative
Product analysis summary: the device was returned to medtronic for evaluation.The balloon returned in a post inflated state and kinks were visible on the hyp otube.Blood visible inside the balloon and inflation lumen, indicating a leak.The device failed negative prep.On pressurisation of device a pin hole leak observed, on most proximal end of the working length and balloon failed to maintain pressure.Burst not confirmed but leak confirmed.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
• Common Device Name: 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: 20357992
• Report Number: 9612164-2024-04496
• Device Sequence Number: 20831975
• Product Code: NIQ
• UDI-Device Identifier: 00643169557161
• UDI-Public: 00643169557161
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2026
• Device Model Number: RONYX40015UX
• Device Catalogue Number: RONYX40015UX
• Device Lot Number: 0011929413
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 10/05/2024; 11/12/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/21/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male