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

Model Number RONYX30034X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Shock (2072); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

Journal article: the importance of the ¿safety coronary guidewire¿ in the donor vessel during chronic total occlusion percutaneous coronary intervention year: 2023 reference: https://doi.Org/10.1016/j.Carrev.2023.01.006 b3: date of publication.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.

Event Description

A journal article was submitted for review titled 'the importance of the ¿safety coronary guidewire¿ in the donor vessel during chronic total occlusion percutaneous coronary intervention'.This study describes two cases with donor vessel injury that illustrate the importance of the safety guidewire and of prompt treatment of donor vessel dissections.In case 2 a patient with normal left ventricular systolic function was referred for right coronary artery (rca) chronic total occlusion (cto) percutaneous coronary intervention (pci) for management of angina refractory to maximal medical therapy.Bifemoral 7f access was obtained.The left main (lm) coronary artery was engaged using a 7f ebu 3.5 guide catheter and the rca was engaged using a 7f al1 guide catheter.A non-medtronic (mdt) coronary guidewire was advanced into the left circumflex (lcx) artery as a safety wire.Diastolic pressure ratio (dpr) of the left anterior descending artery (lad) was 0.85, likely due to a combination of moderate proximal lad disease along with lad supplying collaterals to the rca.Considering that the lad disease was angiographically not severe and the dpr value of the lad was expected to improve post successful cto pci of the rca with regression of left to right collaterals, decision was made not to stent the lad.The pressure wire was retained in the distal lad as a safety coronary guidewire.Antegrade wiring was attempted in the rca cto using a three non-mdt wires without success.A decision was made to attempt retrograde crossing.The activated clotting time was 318 seconds, and 2000 units of unfractionated heparin were administered.A septal collateral was cros sed with a non-mdt wire using the surfing technique.A non-mdt microcatheter was subsequently advanced into the distal rca and a non-mdt guidewire was advanced retrogradely across the distal cap in the extra plaque space in preparation for reverse controlled antegrade and retrograde tracking (r-cart).The patient suddenly became hypotensive.Left coronary angiogram revealed slow flow into the lad.The exact mechanism of the slow flow was difficult to ascertain but was likely due to a combination of proximal lad disease along with either spasm and/or proximal lad dissection.The retrograde equipment was removed, and the proximal lad was stented using 3.0 × 34mm resolute onyx drug eluting stent, facilitated by the safety guidewire in the distal lad with restoration of timi-2 flow.The patient continued to be hypotensive and went into cardiac arrest (pulseless electrical activity).Cardiopulmonary resuscitation (cpr) was initiated.Right coronary angiogram was performed however due to non-coaxial guide position of the guide catheter, resulted in aortocoronary dissection involving the proximal rca and right coronary cusp.A lund university cardiac assist system (lucas) device was used for chest compressions followed by initiation of veno-arterial extracorporeal membrane oxygenation (va ecmo) that stabilized the patient.However, the patient became hypotensive again with abdominal distention and significant drop in hemoglobin to 3.8 g/dl (baseline was 10 g/dl).Emergent exploratory laparotomy was performed that revealed intra-abdominal bleeding resulting from injury to the posterior portal vein and liver laceration that was likely secondary to chest compressions and rib fractures.No retroperitoneal bleeding was noted.The patient's hospital course was complicated by hemorrhagic and cardiogenic shock, massive transfusion of blood products, complete heart block requiring permanent pacemaker placement, gastrointestinal bleeding, bilateral lower extremity deep venous thrombosis and delirium.No cardiac surgery was needed for the right aortocoronary dissection.After 8 weeks the patient was discharged to a transitional care unit.A computed tomogram of the chest done 10 weeks later to rule out pulmonary embolism did not show aortic dissection.It was not believed that there was any causal relationship between the resolute onyx device and any of the adverse events (cardiac arrest, hypotension, dissection, blood loss, cardiogenic shock, lower leg dvt, complete heart block) reported.

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 ; 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: 18442648
• MDR Text Key: 331866680
• Report Number: 9612164-2024-00055
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RONYX30034X
• Device Catalogue Number: RONYX30034X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• 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; Other
• Patient Age: 73 YR
• Patient Sex: Female