MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN AAA; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number AAAXXXX

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

Patient Problems Aneurysm (1708); Vascular System (Circulation), Impaired (2572)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

This complaint was found during a recent clinical evaluation review/literature search of this device.The citation is as follows: georgiadis, g.S., chatzigakis, p.K., kouvelos, g., argyriou, c., kopadis, g.C., georgakarakos, e.I., & matsagkas, m.(2020).Multicenter mid-term results after endovascular aortic aneurysm repair with the incraft® device.Annals of vascular surgery.Doi:10.1016/j.Avsg.2020.09.018.Specific product details are not available.The exact event date is unknown.As reported in the literature article by, georgiadis, g.S., chatzigakis, p.K., kouvelos, g., argyriou, c., kopadis, g.C., georgakarakos, e.I., & matsagkas, m.(2020).Multicenter mid-term results after endovascular aortic aneurysm repair with the incraft® device.Annals of vascular surgery, s0890-5096(20)30864-5.Advance online publication.Https://doi.Org/10.1016/j.Avsg.2020.09.018, https://doi.Org/10.1016/j.Avsg.2020.09.018, one patient experienced sac enlargement >5 mm in diameter compared with the 1-month ct scan and had type ii endoleak after being treated with the incraft -aaa delivery systems.77 patients with infrarenal abdominal aortic aneurysms (aaa) =50mm in diameter treated with the incraft device in three vascular centers were enrolled from november 2015 to july 2018.Follow-up was completed in august 2020.Selection of evar using the incraft device was individualized according to aorto-iliac morphologic features, comorbidities, history of previous abdominal surgery and preference of the patient.The product was not retuned for analysis.The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿stent-graft endoleak type ii¿ and ¿abdominal aortic aneurysm enlargement¿ could not be confirmed as the device was not returned for analysis nor were procedural images provided for review.The exact cause could not be determined.Type ii endoleaks account for approximately 40% of all endoleaks encountered in clinical practice and are the most common.They occur when there is retrograde flow of blood into the aneurysm sac via an excluded aortic branch, most commonly the inferior mesenteric artery or a lumbar artery.Many type ii endoleaks close spontaneously over time.As such at many institutions these leaks are not treated immediately; watchful waiting is employed and if the leak persists it is treated by embolizing the branch vessel.There is a complete seal around the graft attachment zones so the complications are not directly related to the graft itself.Type 2 endoleak occurs in up to 20% of patients after endovascular aneurysm repair (evar).Type ii endoleaks tend to be benign in nature, carrying little, if any, potential for aneurysm enlargement and rupture.As such, most patients require follow up and observation only.It is unknown how this patient was followed.According to the safety information in the instructions for use ¿it is recommended that physicians conduct regular examinations and imaging for the patient¿s lifetime.Follow-up imaging should be decided based upon the physician¿s clinical assessment of the patient pre- and post-implantation of the stent graft.After endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.Annual imaging is recommended, including abdominal radiographs to examine device integrity (stent fracture, separation between bifurcated device and proximal cuffs or limb extensions, if applicable); and contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease.If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.¿ no corrective or preventive action will be taken, given that; with the information provided the reported event does not appear to be related to the manufacturing process.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported in the literature article by, georgiadis, g.S., chatzigakis, p.K., kouvelos, g., argyriou, c., kopadis, g.C., georgakarakos, e.I., & matsagkas, m.(2020).Multicenter mid-term results after endovascular aortic aneurysm repair with the incraft® device.Annals of vascular surgery, s0890-5096(20)30864-5.Advance online publication.Https://doi.Org/10.1016/j.Avsg.2020.09.018, https://doi.Org/10.1016/j.Avsg.2020.09.018, one patient experienced sac enlargement >5 mm in diameter compared with the 1-month ct scan and had type ii endoleak after being treated with the incraft -aaa delivery systems.77 patients with infrarenal abdominal aortic aneurysms (aaa) =50mm in diameter treated with the incraft device in three vascular centers were enrolled from november 2015 to july 2018.Follow-up was completed in august 2020.Selection of evar using the incraft device was individualized according to aorto-iliac morphologic features, comorbidities, history of previous abdominal surgery and preference of the patient.The device will not be returned as it was implanted.

• Brand Name: UNKNOWN AAA
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10734767
• MDR Text Key: 213050534
• Report Number: 9616099-2020-04012
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: M140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2020

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: AAAXXXX
• Device Catalogue Number: AAAXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: No
• 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