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

Model Number ETCF3232C49EE

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

Patient Problems Pain (1994); Cardiac Tamponade (2226); Vascular Dissection (3160); Pericardial Effusion (3271)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; transcatheter self-expanding stent closure of sinus venosus atrial septal defects with indigenous method of determining appropriate stent length without advanced imaging techniques -a case series of single centre experience muthukumaran et al, (https://www.Sciencedirect.Com/science/article/pii/s2468600x21000463) https://doi.Org/10.1016/j.Ihjccr.2021.10.011.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft was implanted off label in a patient during the transcatheter closure of a sinus venous atrial septal defect (svasd).It was reported 4 hours post the index procedure, surveillance tte done prior to transfer out from recovery room showed stent in position, no residual shunt with no pericardial effusion however later in the evening the patient developed hemodynamic compromise with acute onset interscapular area pain.Repeat tte showed pericardial effusion with signs of cardiac tamponade.Emergency pericardiocentesis showed haemorrhagic fluid with transient improvement in vitals.A further repeat tte showed recurrent pericardial collection despite continuous drainage and her hemodynamics later started to deteriorate.The patient was taken for emergency exploratory thoracotomy.Intrapericardial exploration revealed stent anchoring pins/barbs protruding out through svc, scraping the adjacent ascending aortic wall with a tiny rent in the ascending aorta.Surgical removal of stent and repair of rent in ascending aorta along with closure of sv asd was done.After successful surgical correction the patient was reported as stable and discharged on post-operative day 5.Per the physician the cause of the pericardial effusion is undetermined.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Additional information received: it was confirmed that none of the adverse events mentioned in the article are related to the endurant device model etcf3232c49ee.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: 13532893
• MDR Text Key: 285601787
• Report Number: 9612164-2022-00614
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

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: ETCF3232C49EE
• Device Catalogue Number: ETCF3232C49EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/10/2022
• 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: 79 KG