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

Model Number RONYX35026UX

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

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 a resolute onyx rx drug eluting stent to treat a lesion.The device was inspected with no issues noted.Negative prep was performed.It was reported that the stent dislodged.The patient is alive with no injury.

Manufacturer Narrative

Additional information: adverse event <(>&<)> product problem selected intervention required ticked the resolute onyx device was being used to treat a slightly tortuous lesion with some calcium exhibiting 80% stenosis in the proximal lad.The device was prepped as per ifu.No issues were noted.The lesion was not pre-dilated.The device did not pass through a previously deployed stent but it was placed proximal to a freshly implanted stent and the distal end of the resolute onyx device overlapped with the proximal end of the other stent.Resistance was not noted while advancing the stent.Resistance was not noted during withdrawal of the device.It was later reported that a short time after the stents had been placed, the patient reported chest paint and had st segment elevation.The patient was brought back to the cath lab where it was observed that there was a clot inside the resolute onyx stent.The physician successfully passed a 0.14 guidewire through the stents and advanced a non-medtronic aspiration catheter over the wire.While advancing the aspiration catheter into the resolute onyx stent, it was very difficult to pass through and some force was used.As a result, the aspiration catheter seemed to "jump" through the stent strut.Aspiration was performed.As the aspiration catheter was removed it came out with some difficulty.W hen the aspiration catheter was removed from the body, the physician noted the resolute onyx stent attached to the it.The physician suspected that the stent had been malapposed to the vessel wall, causing the thrombosis.The physician then used oct (optical coherence tomography angiography) to size the vessel, placed another stent into the proximal lad and post dilated the stent after using oct again.The patient was reported to be in stable condition and was subsequently discharged.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: annex d code added 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 ; EI
• MDR Report Key: 11327158
• MDR Text Key: 232158820
• Report Number: 9612164-2021-00640
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557109
• UDI-Public: 00643169557109
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2021
• Device Model Number: RONYX35026UX
• Device Catalogue Number: RONYX35026UX
• Device Lot Number: 0010052536
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention