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

Model Number	ETCF2828C49E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis bifurcate stent graft and three endurant ii limbs were implanted during the endovascular treatment of an abdominal aortic aneurysm.It was reported that during a follow-up ct scan over 4 years later, a type ia endoleak and a suspected type ib endoleak were found by the radiology.4 days later the patient returned to the or for secondary intervention to treat the type ia leak and extend the distal seal in the rcia.A 28mm proximal cuff was deployed at the floor of the right renal, thus extending the proximal seal by 5 to 7 mm.Next, a 16 ¿ 20¿82 flared iliac limb was deployed on the right side to extend the distal seal by 1.5 to 2 cm, all the way to the right common iliac bifurcation.After ballooning the proximal and distal seal zones as well as overlapped segments, the initial completion angiogram showed a brisk type ia leak on the left lateral aspect of the graft.The physician then successfully deployed 10 endoanchors circumferentially at the top of the aortic cuff, specifically placing 7 anchors in the left anterior and left posterior quadrants.A second completion angiogram was performed which confirmed complete resolution of the type ia leak.The cause of the type ia and ib endoleaks were not provided.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received; it was reported that no type ib was observed, but the right limb did receive an extension as a pre cautionary measure.It was reported in relation to a cause of the ia endoleak, the patient was initially treated for a rapidly expanding aneurysm, so possibly a combination of continued disease progression and initial placement of the main body about 5mm distal to the renal may have caused the event.A4: updated b7: updated 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.
Additional Manufacturer Narrative
Film evaluation summary: the reported type ia endoleak after cuff implantation at re-intervention could not be assessed on the images provided; therefore, the cause of the event could not be determined.Procedural and post-implant angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause.Therefore, a complete assessment of the stent graft in-v ivo configuration and endoleak evaluation could not be performed.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 AORTIC STENT GRAFT
• Common Device Name: 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: 13869007
• Report Number: 9612164-2022-01123
• Device Sequence Number: 12080203
• Product Code: MIH
• UDI-Device Identifier: 00613994991447
• UDI-Public: 00613994991447
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: ETCF2828C49E
• Device Catalogue Number: ETCF2828C49E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 03/23/2022; 04/15/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/13/2022; 05/10/2022
• Date Device Manufactured: 08/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 72 KG