MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT IIS BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number ESBF3214C103E

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant iis bifurcate stent graft system was intended to be implanted in the endovascular treatment of a unknown sized abdominal aortic aneurysm.It was reported that during the index procedure, when trying to deliver the delivery system through the iliac access, it was noted the access was tight and contained plaque.It was felt the artery was too small and a dissection subsequently occurred.A balloon expandable stent was placed on the right external iliac artery as treatment and a smaller size bifurcate esbf2814c103e was then able to be delivered and implanted without issue.As per the physician the cause of the event was anatomy and noted the small plaque filled artery.No additional clinical sequalae were provided and the patient is fine.

Manufacturer Narrative

Film evaluation summary; the reported difficult to position could not be assessed on the films received.Difficulties in advancing and positioning the device in the patient could be appreciated on viewing the severely calcified anatomy observed on the 3d mensio report received.Procedural angiograms showing attempts to deploy the device were not received for thorough analysis of the event.The observed calcification would have resulted in appreciable narrowing of the access vessels.It is most likely that the narrowed and calcified vessels were related to the difficult to advance issues with subsequent dissection.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 IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10717053
• MDR Text Key: 212451082
• Report Number: 9612164-2020-04044
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439962
• UDI-Public: 00643169439962
• Combination Product (y/n): N
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: ESBF3214C103E
• Device Catalogue Number: ESBF3214C103E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/03/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 83 YR