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

Model Number RONYX25018UX

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Leak/Splash (1354)

Patient Problems Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use two resolute onyx coronary drug eluting stents (one ronyx25022ux, pli10 and one ronyx25018ux, pli20) to treat a moderately tortuous, severely calcified lesion exhibiting 90% stenosis located in the mid left anterior descending (lad) artery and diagonal branch.The devices were inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated using two non-medtronic wires and two non-medtronic 2.5x15 balloons.It was stated that pre-dilation was difficult due to calcium.The devices did not pass through a previously deployed stent.Resistance was encountered when advancing the devices.Excessive force was not used during delivery of ronyx25022ux, pli10.Excessive force was used during delivery of ronyx25018ux, pli20.It was reported that the first stent (ronyx25022ux, pli10) balloon burst/leaked during stent deployment at 12 atm for 30 seconds.It was stated that during first inflation the balloon did not fully inflate, the proximal end of the stent expanded and the stent catheter system had to be pulled back with difficulty.The stent was deployed using two non-medtronic balloons, a 1.5x15mm and a 2.5x15mm.It was stated that another resolute onyx stent (ronyx25018ux, pli20) was then attempted to be used to cover the rest of the lesion, however it was reported that this stent did not inflate fully either at 8atm for 15 seconds and a burst/leak occurred.The stent was deployed using a non-medtronic 2.5x15mm balloon at 14atm for 15 seconds.The diagonal branch shut down and was opened again using a 1.5mm and 2.0mm non-medtronic balloon catheters.The patient was reported to be alive with no further injury.

Manufacturer Narrative

Product analysis summary: the balloon folds were expanded, the stent had been deployed.The balloon passed negative prep.The balloon was inflated to nominal pressure of 12atm and the balloon had maintained pressure.No leak or burst site was identified on the balloon.No damage was noted to the remainder of the device.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: the devices were not moved or repositioned in the lesion while being inflated.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: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11730556
• MDR Text Key: 247517917
• Report Number: 9612164-2021-01660
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556812
• UDI-Public: 00643169556812
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2023
• Device Model Number: RONYX25018UX
• Device Catalogue Number: RONYX25018UX
• Device Lot Number: 0010514357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention