MAUDE Adverse Event Report: MEDTRONIC IRELAND UNK-CV-SR; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number UNK-CV-SR

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

Patient Problems Pain (1994); Numbness (2415); Obstruction/Occlusion (2422)

Event Date 10/12/2022

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; treatment of recurrent iliac branch occlusion after en dovascular repair of abdominal aortic aneurysm diagnosed by contrastenhanced ultrasound combined with computed tomography angiography: a case report wang et al, ann transl med 2022;10(20):1146.Https://dx.Doi.Org/10.21037/atm-22-4498.Concomitant medical products: other relevant device(s) are: s/n: unknown; use by date: unknown; upn # unknown, s/n: unknown; use by date: unknown; upn # unknown.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.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.

Event Description

Unknown medtronic stent grafts was implanted during the endovascular treatment of an abdominal aortic aneurysm on an unknown date.Coil embolization was also completed on the right iliac artery.It was reported the patient had intermittent claudication symptoms of both lower limbs after the surgery.On the one month follow up ct the bilateral iliac branches were anchored in the external iliac artery, and the blood vessels at the distal end of the stent were tortuous.One year post the index procedure, the patient suddenly experienced motor dysfunction of the left lower limb.The cta showed that the left iliac artery stent was occluded and the left ankle brachial index (abi) could not be measured.The patient underwent left femoral artery incision and thrombectomy.Intraoperative dsa indicated that the blood flow at the distal end of the left iliac stent was limited.A non mdt was placed at the distal end of the iliac stent.The motor function of the left lower limb recovered well after surgery.The same year the patient was hospitalized again because of pain and numbness of the left lower limb.Cta showed that the left iliac branch was occluded again.Abdominal ct showed no evidence of a restricted connection between the main stent and the proximal stent of the left iliac branch.On the contrary, the right iliac branch was slightly narrow, but the blood flow was unobstructed.A repeat thrombectomy of the left femoral artery was performed.A right femoral arteriography showed severe stenosis at the distal end of the right iliac stent.After balloon pre-expansion, a non mdt was placed.Angiography at the proximal end of the main stent showed that the blood flow in the stent of the left iliac artery was stagnant.The pulse of the left common femoral artery was weakened.Through dsa, it was found that there was marginal laminar flow at the proximal end of the left iliac branch, and the blood flow velocity significantly decreased.A non mdt (stent was implanted at the proximal junction of the left iliac branch, and the proximal end slightly exceeded the left iliac branch stent.The angle of the proximal end of the left iliac branch was improved through this stent.Another non mdt was introduced into the stent and expanded.Angiography showed that the blood flow of the left iliac artery was significantly improved.After this operation, the claudication symptoms of both lower limbs were significantly relieved.Follow up showed blood flow of bilateral iliac branches was smooth, and no obvious stent stenosis was present.Per the physician the cause of the occlusion is undetermined.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: UNK-CV-SR
• 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: 16147520
• MDR Text Key: 307186846
• Report Number: 9612164-2023-00097
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 01/11/2023

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: UNK-CV-SR
• Device Catalogue Number: UNK-CV-SR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/12/2023
• 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