MAUDE Adverse Event Report: CORDIS CASHEL AAA BIFURCATE 34MM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number AB3498CL

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

Patient Problems Occlusion (1984); Stenosis (2263)

Event Date 01/01/1980

Event Type  Injury  

Manufacturer Narrative

The implant date is unknown.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 34mm aaa bifurcate main body iliac graft got severely occluded.Iliac needed to be reworked due to stenosis.The product is implanted so it is not possible to return it.

Manufacturer Narrative

Complaint conclusion: the 34mm aaa bifurcate main body iliac graft got severely occluded.Iliac needed to be reworked due to stenosis.The product was not returned for analysis.A product history record (phr) review of lot 17331114 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿in-stent peripheral artery restenosis¿ and ¿stent occlusion¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics or procedural factors may have contributed to the reported event but these remain unknown despite follow-ups.According to the safety information in the instructions for use ¿potential adverse events and potential device risks include, but are not limited to prosthesis occlusion/stenosis.Follow up procedure 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.¿neither the phr nor the very limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: AAA BIFURCATE 34MM
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9531709
• MDR Text Key: 175896033
• Report Number: 9616099-2019-03439
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

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 Expiration Date: 03/13/2020
• Device Model Number: AB3498CL
• Device Catalogue Number: AB3498CL
• Device Lot Number: 17331114
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1