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

Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problems Myocardial Infarction (1969); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 03/11/2023

Event Type  Injury  

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.

Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately calcified lesion in the mid left anterior descending artery (lad).It was reported that the stent deformation occurred in vivo post deployment.It was detailed that the patient had the resolute onyx stent implanted on (b)(6) 2023.The patient returned to the hospital on (b)(6) 2023, in an acute event.It appeared that the stent was crushed on the distal end which caused thrombus and a heart attack.The cause of the event is unknown, but it is believed that when the wire was pulled out on the (b)(6), the wire caught a stent strut and the stent was pulled down.An angiogram had not been performed after the wire was removed.A replacement stent was implanted on (b)(6).The patient's ejection fraction (ef) was 65% but is now 25%.The patient is alive with no further injury.

Manufacturer Narrative

Additional information: in the index procedure on the (b)(6) 2023; the lesion was predilated.The device did not pass through a previously deployed stent.Resistance was noted while advancing the device to the lesion.No excessive force was used when delivering the device.Stent deformation was confirmed based on intravascular ultrasound (ivus) and angiographic pictures.The thrombus was found in the circumflex vessel.The wire removal during the index procedure could have caught a stent strut and caused the stent deformation.The patient was supposed to be on dual antiplatelet therapy since the index procedure, but it believed that the patient was not compliant with plavix, which may also have contributed to the thrombus.The patient has been in icu with non-medtronic ventricular assist device since the event.The patient spent one week in icu.The physician has assessed that the thrombus and heart attack events may have been related to the device, but also may have been related to the non-medication compliance.Patient information provided section a.Annex d code.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16597066
• MDR Text Key: 311823595
• Report Number: 9612164-2023-01226
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male