MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 8X100; STENT, ILIAC

Model Number C08100SL

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

Patient Problem Rupture (2208)

Event Date 01/14/2021

Event Type  Death  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17929758 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by gore japan, a patient expired after an on-site operation.An 8mm x 100mm smart stent (ses) was used to treat a lesion in the right external iliac artery.Post-dilatation with an unknown balloon was done, rupturing a blood vessel and bleeding occurred.The vessel rupture occurred while the unknown balloon was in the stent during post-dilatation.For hemostasis, non-cordis stent grafts were deployed.A non-cordis balloon expandable stent graft was deployed on the central side, and a second non-cordis stent graft was deployed on the peripheral side.Hemostasis was achieved and the patient¿s vital signs were stable, so the procedure was terminated.Approximately one day post procedure, the patient had a sudden change in condition requiring re-operation.Re-bleeding occurred, the cause of which was a suspected type 2 endoleak.Two unknown stent grafts and three unknown balloon dilatation stent grafts were implanted from the aorta to the bilateral iliac arteries using covered endovascular reconstruction of aortic bifurcation (cerab) technique to occlude the lumbar artery and contralateral internal iliac artery that may be communicating near the bleeding site.After confirming that there was no endoleak, the procedure was completed.Five days after the procedure, the patient expired.No information was available on the life-saving measures taken.

Event Description

As reported by gore japan, a patient expired after an on-site operation.An 8mm x 100mm smart stent (ses) was used to treat a lesion in the right external iliac artery.Post-dilatation with an unknown balloon was done, rupturing a blood vessel and bleeding occurred.The vessel rupture occurred while the unknown balloon was in the stent during post-dilatation.For hemostasis, non-cordis stent grafts were deployed.A non-cordis balloon expandable stent graft was deployed on the central side, and a second non-cordis stent graft was deployed on the peripheral side.Hemostasis was achieved and the patient¿s vital signs were stable, so the procedure was terminated.Approximately one day post procedure, the patient had a sudden change in condition requiring re-operation.Re-bleeding occurred, the cause of which was a suspected type 2 endoleak.Two unknown stent grafts and three unknown balloon dilatation stent grafts were implanted from the aorta to the bilateral iliac arteries using covered endovascular reconstruction of aortic bifurcation (cerab) technique to occlude the lumbar artery and contralateral internal iliac artery that may be communicating near the bleeding site.After confirming that there was no endoleak, the procedure was completed.Five days after the procedure, the patient expired.No information was available on the life-saving measures taken.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6.As reported by gore japan, a patient expired after an on-site operation.An 8mm x 100mm smart stent (ses) was used to treat a lesion in the right external iliac artery.Post-dilatation with an unknown balloon was done, rupturing a blood vessel and bleeding occurred.The vessel rupture occurred while the unknown balloon was in the stent during post-dilatation.For hemostasis, non-cordis stent grafts were deployed.A non-cordis balloon expandable stent graft was deployed on the central side, and a second non-cordis stent graft was deployed on the peripheral side.Hemostasis was achieved and the patient¿s vital signs were stable, so the procedure was terminated.Approximately one day post procedure, the patient had a sudden change in condition requiring re-operation.Re-bleeding occurred, the cause of which was a suspected type 2 endoleak.Two unknown stent grafts and three unknown balloon dilatation stent grafts were implanted from the aorta to the bilateral iliac arteries using covered endovascular reconstruction of aortic bifurcation (cerab) technique to occlude the lumbar artery and contralateral internal iliac artery that may be communicating near the bleeding site.After confirming that there was no endoleak, the procedure was completed.Five days after the procedure, the patient expired.No information was available on the life-saving measures taken.The device was not returned for analysis.A product history record (phr) review of lot 17929758 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the limited information provided, the reported ¿arterial rupture¿ could not be confirmed, and the exact root cause could not be determined.According to the instructions for use, "safety and effectiveness has not been demonstrated in: lesions that are either totally or densely calcified.If resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.Set the backer board with carrier tube on a flat surface.Remove the stent/delivery system from the carrier tube.Examine the device for damage.If it is suspected that the sterility has been compromised or the device is damaged do not use the device.Perform an arterial angiogram to verify full deployment.If incomplete expansion exists within the stent at any point along the lesion, post deployment balloon dilatation can be performed at the discretion of the physician.Remove the balloon from the patient.¿ moreover, its is highly probable that the post-dilatation with the unknown balloon resulted in the rupturing of the blood vessel and thus bleeding occurred as voiced by the customer.The vessel rupture occurred while the unknown balloon was in the stent during post-dilatation.Neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART CONTROL, ILIAC 8X100
• Type of Device: STENT, ILIAC
• 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: 16471139
• MDR Text Key: 310547892
• Report Number: 9616099-2023-06290
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024256
• UDI-Public: (01)20705032024256(17)230131(10)17929758
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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: 01/31/2022
• Device Model Number: C08100SL
• Device Catalogue Number: C08100SL
• Device Lot Number: 17929758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/07/2023
• Date Device Manufactured: 02/11/2020
• 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: STENT GRAFT (VIABAHN, GORE VBX BALLOON EXPANDABLE).; UNKNOWN BALLOON.; UNKNOWN STENT GRAFT.; UNKNOWN STENT GRAFT.; VIABAHN, GORE.
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male