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

Model Number UNK-AAA

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

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 10/06/2020

Event Type  malfunction  

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.The publication is attached.Complaint conclusion: 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 seven patients received iliac extensions, mainly iia embolization and overstenting for cia or iia aneurysm (planned), to resolve a type ib endoleak (unplanned) or to reach the desired distal landing location (planned) after being treated with the incraft -aaa delivery systems.77 patients with infrarenal abdominal aortic aneurysms (aaa) =50mm in diameter treated with the incraft 42 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 devices will not be returned for analysis as it was implanted to the patients.The products were not returned for analysis.No lot numbers were provided therefore product history record (phr) reviews could not be generated.The reported ¿bifurcated aortic prosthesis endoleak type 1b¿ could not be confirmed as the devices were not returned for analysis nor were procedural images available.The exact cause could not be determined.Vessel characteristics are unknown.As no lot number, catalogue code or other product information was supplied phrs could not be completed.According to the safety information in the instructions for use ¿leaks at the attachment or connection sites should be treated using a balloon catheter to remodel the prosthesis against the vessel wall.Major leaks that cannot be corrected by either re-ballooning may be treated by adding aortic or iliac extension components to the previously placed stent-graft components or any other method per local practice and the clinical situation.Any leak left untreated during the implantation procedure must be carefully monitored after implantation.¿ the information available does not suggest a design or manufacturing related cause for the reported events; 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 seven patients received iliac extensions, mainly iia embolization and overstenting for cia or iia aneurysm (planned), to resolve a type ib endoleak (unplanned) or to reach the desired distal landing location (planned) after being treated with the incraft -aaa delivery systems.77 patients with infrarenal abdominal aortic aneurysms (aaa) =50mm in diameter treated with the incraftr 42 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 incraftr device was individualized according to aorto-iliac morphologic features, comorbidities, history of previous abdominal surgery and preference of the patient.The devices will not be returned for analysis as it was implanted to the patients.

• Brand Name: UNK-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: 10736311
• MDR Text Key: 213182337
• Report Number: 9616099-2020-04014
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-AAA
• Device Catalogue Number: UNK-AAA
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention