MAUDE Adverse Event Report: CORDIS CORPORATION AORTIC BIFURCATE 26MM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number AB2698

Device Problems Material Frayed (1262); Migration (4003); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr reference number: (b)(4).A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the failure of the main body of the incraft aaa stent and threading lead to the deformation of the shape of the stent, the separation of the metal structure from the membrane, and the insertion of the iliac branch could not be carried out multiple times.After various attempts to insert the iliac branch stent, the main stent was seriously displaced, and the head-tip was broken when the iliac branch conveyor was withdrawn.Based on images received, it was noted that there was deformity and mild separation of the body just superior to the bifurcation.There was no reported patient injury.The device was used in an abdominal endovascular aneurysm repair (evar) procedure.The patient initially had a huge ruptured abdominal aortic aneurysm and planned to undergo endovascular isolation with stent implantation in emergency.Several photographs of the device deployment system on the floor of the or were provided.First spot digital image shows successful suprarenal deployment of the body and iliac limb of the device.A wire is in place in the right renal artery.There is significant angulation of the proximal body and narrowing near the graft bifurcation.Second spot image shows the body of the endograft.There is deformity and mild separation of the body just superior to the bifurcation.There appears to have been successful cannulation of the contralateral gate.Third spot image shows an oblique view of the endograft.Again, there is narrowing and deformity of the body of the graft just superior to the flow divider.Fourth image is a dsa image obtained during initial deployment of the proximal attachment.Fifth image shows successful cannulation of the contralateral gate and inflation of a balloon in the body of the endograft.The devices are not expected to be returned for evaluation.

Manufacturer Narrative

This is one of two products involved with the reported event and the associated manufacturer report number is: 9616099-2022-05421.Complaint conclusion: the failure of the main body of the incraft aaa stent and threading lead to the deformation of the shape of the stent, the separation of the metal structure from the membrane, and the insertion of the iliac branch could not be carried out multiple times.After various attempts to insert the iliac branch stent, the main stent was seriously displaced, and the head-tip was broken when the iliac branch conveyor was withdrawn.Based on images received, it was noted that there was deformity and mild separation of the body just superior to the bifurcation.There was no reported patient injury.The device was used in an abdominal endovascular aneurysm repair (evar) procedure.The patient initially had a huge ruptured abdominal aortic aneurysm and planned to undergo endovascular isolation with stent implantation in emergency.The products were not returned for analysis, but procedural images were provided.The procedural images were reviewed by external physician.(b)(6) no product was received for analysis, nine picture related to the reported complaint were attached.On the images provided, there is significant angulation and narrowing of the mid abdominal aorta.The pictures 1, 3, 4, 6 & 7 shows the bifurcate section of the incraft aaa device, 2 unknown wires are also noticed as part of the picture.The stent can be observed damaged.As part of the picture 2 it can be observed an unknown pigtail catheter with the marker bands moved from original place.An unknown device is noticed with the balloon inflated and a crimped stent.The picture 5, 8 & 9 shows 2 devices of incraft aaa catheter, one of them is il 13x12 and the other one il 20 x 12.As part of the picture, it could be observed that one of the devices does not have the distal tip section.No other anomalies of the product can be noticed at the attached pictures.It appears that there was significant procedural difficulty during this case which may be related to anatomical factors.A product history record (phr) review of lot 18000901 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿aortic bifurcate - frayed/split/torn - in patient¿, ¿bifurcate delivery system- separated - in patient¿ and ¿inner member-distal tip - damaged - in patient¿ were confirmed through analysis of the procedural images provided, and were physician reviewed.The exact cause of the event could not be determined as the products were not returned for analysis.Based on the limited information available for review, vessel characteristics (¿on the images provided, there is significant angulation and narrowing of the mid abdominal aorta¿ ) and procedural factors may have contributed to the event as evidenced by the images provided.According to the safety information in the instructions for use ¿the incraft stent-graft system is intended for the endovascular treatment of patients with infrarenal abdominal aortic aneurysms with the following characteristics: femoral access vessels should be adequate to fit the selected delivery system, proximal neck length = 10mm, aortic neck diameters = 17mm and = 31mm, aortic neck suitable for suprarenal fixation, infrarenal and suprarenal neck angulation = 60°, iliac fixation length = 15mm, iliac diameters = 7mm and = 22mm, minimum overall aaa treatment length (proximal landing location to distal landing location) = 128mm, morphology suitable for aneurysm repair.Irregular calcification and/or plaque may compromise the fixation and sealing of the implant, especially at the cranial and caudal sealing zones.Expected potential risks associated with the stent graft system: graft twisting or kinking, incomplete component deployment, insertion and removal difficulties.¿ neither the phr review nor the procedural images provided suggest that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: AORTIC BIFURCATE 26MM
• 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: 13715155
• MDR Text Key: 292842934
• Report Number: 9616099-2022-05420
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 20705032055075
• UDI-Public: (01)20705032055075(17)230131(10)18000901
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P150002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

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 Expiration Date: 01/31/2023
• Device Model Number: AB2698
• Device Catalogue Number: AB2698
• Device Lot Number: 18000901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 03/11/2022
• Supplement Dates FDA Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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
• Treatment: UNK.
• Patient Age: 71 YR
• Patient Sex: Male