MAUDE Adverse Event Report: MEDTRONIC MEXICO BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 96880-025

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

B3: the published date has been used as the event date.Literature citation authors: gian manuel jimenez-rodríguez, daniel manzur-sandoval, ricardo eduardo quirazco-córdova, luis antonio jimenez-ruán, and gustavo rojas-velasco journal name: journal of the canadian cardiovascular society year: 2023 issue number: 1 title of article: percutaneous left ventricular unloading in cardiogenic shock during venoarterial extracorporeal membrane oxygenation: a radial approach literature reference: 10.1016/j.Cjco.2022.11.003 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information via literature regarding a case where a patient with electrical storm that was assisted with peripheral venoarterial extracorporeal membrane oxygenation (va ecmo) developed left ventricular distension (lvd).The patient arrived in the emergency department due to multiple episodes of syncope.On admission, hypotension and tissue hypoperfusion were noted.A diagnosis of cardiogenic shock (cs) was established, and management with inotropes (levosimendan) and a vasopressor (norepinephrine) was started.During the clinical evaluation, the patient developed multiple episodes of unstable ventricular tachycardia (vt) requiring amiodarone, lidocaine, beta-blockers, and multiple electrical shocks from the implantable cardioverter-defibrillator.Despite this therapy, the patient continued with episodes of vt, and electrical storm was diagnosed.The customer¿s center was consulted, and their recommendation to start therapy with peripheral va ecmo was accepted.With previous placement of an intra-aortic balloon pump (iabp) through the right femoral artery, a double cannulation strategy with a femoro-femoral configuration was decided.A 25-french venous cannula was inserted through the right femoral vein directed toward the midright atrium, and a 15-french arterial return cannula was inserted through the left common femoral artery into the midabdominal aorta.The pulmonary flotation catheter was not placed, as the customer stated that they try to avoid stimulation of the right ventricle with the catheter, which could trigger more ventricular arrhythmias in a very irritable myocardium in the context of an electrical storm.Hemodynamic stability was achieved, so the patient was able to be subjected to bilateral stellate ganglion block and a vt ablation procedure.Automated isochronal late activation mapping with ablation catheter via a transseptal approach identified deceleration zones in the septum and anterior wall, and radiofrequency ablation was performed successfully in these zones.The patient remained stable during the procedure.Then, 12 hours later, the patient required a higher fraction of oxygen in the gas mixer, showed congestion of the vascular bed in the chest x-ray, and developed lvd (despite management with inotropes and an iabp) with spontaneous echo contrast, an absence of opening of the aortic valve, and pulmonary edema.At that time, the patient¿s systemic blood pressure was 80/30 mm hg, and the blood flow of the ecmo had to be decreased to 2.3 liters per minute to limit afterload and lvd.An impella device was not available at that moment in the customer¿s center.The patient could not be transferred to the catheterization laboratory, because of extreme hypotension, a 6-french pigtail catheter was introduced through the left radial artery with a 6- french sheath introducer.Its passage through the aorta toward the left ventricular (lv) cavity was guided in real time with transesophagealechocardiogram (tee).The transgastric long-axis view in the tee allowed the customer the visualization of the subvalvular mitral valve apparatus, including the chordae tendineae, so the customer was able to ensure the placement of the catheter in the mid-ventricular region without injuring these st ructures.The correct position of the tip was confirmed with a portable chest x-ray.Then, the pigtail catheter was connected to the extraction cannula.Tee showed resolution of lvd as well as the spontaneous echo contrast and opening of the aortic valve.In addition, the lv end-diastolic pressure was measured, giving a value of 7 mm hg.An increase in systemic blood pressure to 100/70 mm hg was documented, and the blood flow of the ecmo was able to be increased to 3 liters per minute, without evidence of hemolysis.The customer anticoagulated the patient, with unfractionated heparin and a partial thromboplastin time target of 70 to 80 seconds, while using the pigtail.The customer used it for only 48 hours before removing it without any evidence of catheter thrombosis, limb ischemia, or neurologic issues.After 5 days of mechanical circulatory support, the patient was able to be weaned off the va ecmo.All data was collected from a single center.The event involved a 52-year-old male patient.Medtronic cannulae were used during the va-ecmo procedure for this patient (lot numbers not provided).Among all patients, no deaths occurred.Among all patients, adverse events included: left ventricular distension (lvd).Based on the available information, these adverse events may have been attributed to medtronic product.Among all patients, no device malfunctions occurred.

Manufacturer Narrative

Medtronic received additional information was received that of the adverse events that were mentioned within the article, none of them related directly to medtronic devices.The complication that the patient developed was secondary to the ecmo configuration (peripheral va).The patient developed left ventricular distention syndrome, unrelated to the type of cannulas.The performance of the cannulas was optimal during the ecmo running.Additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19142054
• MDR Text Key: 340566647
• Report Number: 9612164-2024-01893
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K052524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96880-025
• Device Catalogue Number: 96880-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 62 KG