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

Catalog Number UNK-AAA

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

Patient Problems Aneurysm (1708); Unspecified Infection (1930); Vascular System (Circulation), Impaired (2572)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

This article was found during a recent literature search of this device.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.The device is an unknown incraft device but the catalog and lot numbers are not available.The citation is as follows : gill, h.L., doonan, r.J., altoijry, a., obrand, d.I., mackenzie, k.S., & steinmetz, o.K.(2018).Early north american experience with the incraft device.Journal of vascular surgery.Doi:10.1016/j.Jvs.2018.10.068.As reported the literary article by gill, h.L., doonan, r.J., altoijry, a., obrand, d.I., mackenzie, k.S., & steinmetz, o.K.(2018).Early north american experience with the incraft device.Journal of vascular surgery.Doi:10.1016/j.Jvs.2018.10.068; reports one patient underwent two attempts at embolization for persistent type ii endoleak with sac expansion.The first attempt was unsuccessful.There was a leak from the inferior mesenteric artery, which could not be cannulated by paraendograft access from the groin as well as through superior mesenteric artery collaterals.The patient was brought back to the radiology suite several weeks later and underwent direct sac puncture, which was successful.However, this same patient later developed a graft infection.Therefore, the graft was explanted, and the physicians performed reconstruction with a new aorto-iliac system with femoral vein.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¿ 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.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.¿ the reported ¿graft infection¿ 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.It is not known what organism caused the infection nor from where the organism originated, whether it was a colony from elsewhere in the body or it was introduced during one of the several procedures to reverse the type ii endoleak.In the warnings and precautions in the safety information in the instructions for use ¿for single use only.Do not resterilize or re-use.Re-use, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failures, which in turn may lead to injury, illness or death of the patient.Note product ¿use by¿ date.Sterilization, storage and handling: the package contents of the incraft® aaa stent-graft system have been sterilized with ethylene oxide gas.The system is provided sterile for single use only.Do not resterilize any components of the system.Use prior to the ¿use by¿ date specified on the package.Product may be used through the last day of the month indicated.Store the packaged incraft® aaa stent-graft system to avoid exposure to extreme temperatures (below -40°c or above 60°c) and humidity.¿ neither the event description 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 the literary article by gill, h.L., doonan, r.J., altoijry, a., obrand, d.I., mackenzie, k.S., & steinmetz, o.K.(2018).Early north american experience with the incraft device.Journal of vascular surgery.Doi:10.1016/j.Jvs.2018.10.068; reports one patient underwent two attempts at embolization for persistent type ii endoleak with sac expansion.The first attempt was unsuccessful.There was a leak from the inferior mesenteric artery, which could not be cannulated by paraendograft access from the groin as well as through superior mesenteric artery collaterals.The patient was brought back to the radiology suite several weeks later and underwent direct sac puncture, which was successful.However, this same patient later developed a graft infection.Therefore, the graft was explanted, and the physicians performed reconstruction with a new aorto-iliac system with femoral vein.

• Brand Name: UNK-AAA
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8261411
• MDR Text Key: 133567249
• Report Number: 9616099-2019-02652
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2019

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
• Device Catalogue Number: UNK-AAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/18/2019
• 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): Life Threatening; Required Intervention