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

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

Patient Problems Anemia (1706); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Rupture (2208); Sweating (2444); Abdominal Distention (2601)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; repeat rupture of a giant abdominal aortic aneurysm after evar meekel et al, ejves short reports (2019) 42, 15e17.Exact date of event unknown.Exact date of implant unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant aui stent graft system was implanted in a patient for the endovascular treatment of a ruptured 90mm abdominal aortic aneurysm.A femorofemoral crossover bypass was also completed during the index procedure an endurant aortic cuff was implanted proximally for the treatment of an intra-operative type ia endoleak.It was reported on an approximately the patient presented with acute abdominal pain.Aneurysm expansion to 120mm due to a type iii endoelak was diagnosed.This was due to dislocation of an endurant iliac stent from the main body.The event was successfully treated with an additional endurant iliac stent graft reconnecting the main body and iliac extension.Follow up in 4 years post the index procedure revealed aneurysm expansion at 130mm.It was reported approximately 5 years post the index procedure, the patient presented with severe abdominal pain with pale palour and sweating.On examination the patient was noted to have symptoms of abdominal distension, hypotension and blood results revealed severe anemia.Ct confirmed a ruptured aaa with a large retroperitoneal haematoma and a type ia endoleak.Aneurysm expansion was observed at 180mm.An open surgical repair was performed with explant of the stent grafts and implantation of a non mdt aortic bifurcation prosthesis.The patient's condition was reported as well post op with was discharged home one week post procedure.The cause of the event is undetermined.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

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 STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8424052
• MDR Text Key: 138892757
• Report Number: 2953200-2019-00374
• Device Sequence Number: 1
• Product Code: MIH
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR