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

Model Number RONYX20022X

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

One everest inflation device was also attempted to be used during the procedure.There was no damage noted to the device packaging.The device was removed from the packaging per ifu with no issues noted.The device was inspected with no issues noted.It was reported that leakage was noted at the pre-dilation stage, when the device was connected to a semi-compliant balloon.The leak occurred at the connection of the manometer to the syringe body.It was stated that pressure was unable to be held, the physician had to continuously dial up the pressure to maintain balloon integrity.The pressure gauge showed pressure dropping.One resolute onyx drug eluting stent was also attempted to be used to treat a mildly tortuous, moderately calcified lesion in the distal lad.The device was inspected with no issues noted.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 and excessive force was not used.It was reported that the balloon burst during stent deployment on the first inflation, at approximately 10-11 atm.It was observed after incident that momentarily there was no flow in the lad vessel.St elevation noted on ecg.The patient is reported to be alive with no injuries.

Manufacturer Narrative

Product analysis summary: four mp4 video files were provided for review.A stent was delivered to the distal lad.Contrast was observed leaking from the distal section of the balloon.The final video file confirms the successful treatment of the lad.There were no images provided showing the reported no flow in the vessel, or the stent not apposing to the vessel wall and the post dilation of the stent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the inflation device was prepped and purged prior to use, and there wasn't any issues observed during prep.A stopcock was not connected between the everest device and the other device.The resolute onyx device was not moved or repositioned in the lesion prior to the burst.It was noted that only one inflation was performed prior to the issue occurring with the resolute onyx device.The pressure drop of the onyx balloon was noted to be gradual as observed from the inflation device gauge.The stent was subsequently implanted.It is stated that the onyx stent was not fully opposed to the vessel wall even though it was deployed at the lesion.After deployment, an nc balloon was used to oppose the stent and the procedure was managed to be completed without the patient requiring further intervention.It was indicated that a new everest inflation device was opened and was being used with the resolute onyx device after the first everest device leaked.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: device returned for evaluation.The device returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurization of the device, liquid was observed exiting the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a pinhole burst on the balloon material immediately proximal to the balloon distal cone.There was no other damage evident 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

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
• MDR Report Key: 10337989
• MDR Text Key: 200804732
• Report Number: 9612164-2020-02787
• Device Sequence Number: 1
• Product Code: NIQ
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: RONYX20022X
• Device Lot Number: 0009588128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 09/08/2020; 10/06/2020; 10/06/2020
• Supplement Dates FDA Received: 08/31/2020; 09/29/2020; 10/12/2020; 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1