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

Catalog Number RONYX27534X

Device Problem Material Deformation (2976)

Patient Problems Occlusion (1984); Thrombus (2101); Injury (2348)

Event Date 08/04/2020

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 one nc sprinter rx ptc balloon catheter to treat a non-tortuous, non-calcified lesion located in the mid/proximal left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.The nc sprinter was being used to post dilate a deployed resolute onyx (ronyx27534x) stent.It was reported that the balloon burst during balloon inflation at 20 atms.The burst occurred on the second inflation after repositioning.The device was not moved or repositioned in the lesion while inflated.One inflation was performed at 20 atm in the distal portion prior to the issue occurring.It was stated that fluctuation was noted on the indeflator indicator but that nothing happened to the nc sprinter.The nc sprinter was pulled back and a second inflation was then performed at 20 atm in mid/proximal lad.The nc sprinter was then noted to be out of shape, with the proximal portion inflated and the distal portion not inflated.The nc sprinter was removed.The deployed ronyx27534x stent was then noted to be elongated, causing thrombus and reduced blood flow in the vessel.Small balloons were then used to restore flow in the vessel, as well as stenting a ronyx30022x device over the elongated part of the ronyx27534x stent.The patient was reported to be alive with no injury.

Manufacturer Narrative

Additional information: it was also believed that maybe pieces of retained balloon got trapped behind the new deployed stent, however, this has not been confirmed.It was stated that after stenting over the damaged stent, an angiogram was conducted and did not show any signs of the suspected balloon fragments.Thus it is believed that the fragments may be crushed behind the stent.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: it was stated that slight resistance was felt while wiring through the nc sprinter but the device was continued as the balloon was able to get to the lesion site.It was stated that the resolute onyx (ronyx27534x) was fully expanded.The patient was reported to be alive with no further injury.It was stated that its possible that the thrombus was related to the reduced flow.It was also stated that it could have been the deformed stent struts jutting into lumen or remains of the torn balloon that caused the diminished flow as when the balloon was removed, 2/3 of the balloon was gone.It was also believed that maybe pieces of retained balloon got trapped behind the new deployed stent.The patient was on dapt at the time of the thrombotic event occurred.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.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: 10442248
• MDR Text Key: 204032448
• Report Number: 9612164-2020-03103
• 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
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2021
• Device Catalogue Number: RONYX27534X
• Device Lot Number: 0010063467
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention