MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II EXTENSION CUFF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number ETCF3232C49E

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

Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; unanticipated complication of transcatheter correction of superior sinus venosus atrial septal defect yalamanchi r, c.Sivaprakasam m, vijendra reddy janke r, chandrasekharan k, shankar sadhasivam v, showkathali r journal of cardiology cases 25 (2022) pp.99-102 https://doi.Org/10.1016/j.Jccase.2021.07.005.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient with complaints of dyspnea was diagnosed to have a superior sinus venosus atrial septal defect with dilated right-sided chambers, large left to right shunt and normal biventricular systolic function on transthoracic echocardiogram.Intervention was performed where under fluoroscopic and transesophage echocardiography (tee) guidance, assessment for feasibility of transcatheter correction was performed with balloon occlusion of superior vena cava with a non mdt balloon.Subsequently the patient underwent transcatheter correction using a 32 x 49mm endurant ii stent graft in superior vena cava accessed via 18f sheath in right femoral vein (rfv) under general anesthesia.Post stent deployment rupv angiogram was done to show unobstructed flow in right upper pulmonary vein and no residual shunt.Stent position was also confirmed with both tee and computed tomography (ct) scan.The procedure was then completed.Surveillance tte done prior to transfer from the cardiac care unit (ccu) after 4 hours showed stent in-situ, with no residual shunt and pericardial effusion.Nine hours post-procedure, the patient suddenly developed back pain and was found to be tachycardic (106 bpm) with blood pressure of 80/60 mmhg.Repeat tte showed large pericardial effusion with signs of cardiac tamponade.The patient then underwent emergency pericardiocentesis and 200 ml of hemorrhagic fluid was aspirated.The patients clinical and hemodynamic parameters improved but then worsened again after 3 hours and a repeat tte showed recurrent pericardial collection despite continuous drainage.The cardiac surgical team was involved for emergency exploratory thoracotomy, which revealed anchoring pins or barbs protruding out through svc, scraping the adjacent ascending aortic wall with a tiny rent in the ascending aorta.There was no leak from the svc.The rent in the aorta was sutured and surgical felt was placed around the svc at the level of the barbs to avoid further injury to the aorta.Repeat tte after a few hours showed stent in-situ with no pericardial effusion.It was reported that the suprarenal stents in other similar cases were placed higher up in the superior vena cava, where the ascending aorta courses away from the svc, than in this patient, the barbs were too close to the aorta.It is believed that the injury to the aorta in this patient is due to this close proximity and happened only when the patient started to mobilize with changes in hemodynamics.Another probable reason can be the slow expansion of the graft over a few hours after deployment leading to barbs projecting out of the svc and perforating the aorta.No additional clinical sequalae were provided and the patient is fine.

Manufacturer Narrative

As physician this event is not related to the mdt product.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: ENDURANT II EXTENSION CUFF
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• 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: 13617073
• MDR Text Key: 286251177
• Report Number: 9612164-2022-00800
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ETCF3232C49E
• Device Catalogue Number: ETCF3232C49E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/09/2022
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 70 KG