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

Catalog Number RONYX35030JX

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was reported to be on dapt for stable angina.On (b)(6) 2018, three resolute onyx rx coronary drug eluting stents were implanted to treat a lesion located in the right coronary artery # 1, # 2, and # 3.It was stated that poba was performed and timi flow 3 was achieved.On (b)(6) 2019, one year on another resolute onyx stent was implanted.It was reported that on (b)(6) 2019 the patient suffered from stent thrombosis and non-fatal myocardial infarction developed.It was stated that it was probable that there was a site of poor stent expansion due to some calcification and that there was some thrombosis.The treatment had to be terminated in a slow flow state, which was considered to cause the thrombosis.The background factor was considered to be a hemodialysis (hd) patient.It was stated that an emergency pci was performed for rca # 1, # 2, and # 3 on the same day.Thrombus aspiration was performed but no stent placement.Timi flow grade 0 -> 2 was achieved.The patient was reported to have recovered from non-fatal myocardial infarction.The next day cardiac dysfunction occurred and an emergency pci was performed on the rca # 2.Thrombus aspiration was performed and poba was performed.No stent implantation was performed.Pcps was used.Timi flow grade 0 -> 0 was achieved.Two days later the patient recovered from cardiac dysfunction and stent thrombosis.

Manufacturer Narrative

Additional information: on 05 june 2018, three resolute onyx rx coronary drug eluting stents were implanted to treat lesions of the right coronary artery (rca), located in the rca to right ventricular branch (#1), the right ventricular branch to the acute marginal branch (#2) and the acute marginal branch to the posterior descending branch (#3).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: on 05 june 2018, four resolute onyx rx coronary drug eluting stents were implanted to treat lesions of the right coronary artery (rca), located in the rca to right ventricular branch (#1), the right ventricular branch to the acute marginal branch (#2) and the acute marginal branch to the posterior descending branch (#3).It was reported that approximately 13 months post procedure (31 july 2019) the patient suffered from stent thrombosis and non-fatal myocardial infarction developed the following day (01 aug 2019).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.

• 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: 11513041
• MDR Text Key: 240565355
• Report Number: 9612164-2021-01024
• 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
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX35030JX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR