MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 6X60ML; STENT, ILIAC

Catalog Number C06060ML

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

Patient Problems Reocclusion (1985); Vascular System (Circulation), Impaired (2572)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as it remains implanted.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the patient was implanted with a smart control stent in the target lesion without issue.The patient was a (b)(6)-old male and the original target lesion was the proximal portion of the left femoral artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.Approximately three years and 6 months after the index procedure, a restenosis in the lower leg was confirmed via echography.A month after, a revascularization was performed in the target lesion and the patient recovered.Additional procedural details were requested but are unknown.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.As reported, the patient was implanted with a smart control stent in the target lesion without issue.The patient was a (b)(6) male and the original target lesion was the proximal portion of the left femoral artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.Approximately three years and 6 months after the index procedure, a restenosis in the lower leg was confirmed via echography.A month after, a revascularization was performed in the target lesion and the patient recovered.Additional procedural details were requested but are unknown.The device was not returned for evaluation as it remains implanted.A review of the manufacturing documentation associated with lot 15642766 presented no issues during the manufacturing process that can be related to the reported event.Without the return of the device for analysis or procedural films, the reported event could not be confirmed and the exact cause could not be determined.Restenosis is a known potential adverse event associated with implanting stents.Restenosis is often associated with the progression of artery disease.The act of stent implantation produces intended damage to the intima of the vessel wall in order to remodel the wall and reestablish patency of the vessel.The disruption of the intimal layers triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation in side of the stent and instigate vessel remodeling around the stent, producing gaps between the stent and the vessel wall.Given the limited information available for review, patient, lesion and/or pharmacological factors may have contributed to the reported event.There is nothing to suggest that the reported event is related to the design and manufacturing process of the device.Therefore no corrective action will be taken.

• Brand Name: SMART CONTROL, ILIAC 6X60ML
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6787700
• MDR Text Key: 82465869
• Report Number: 9616099-2017-01312
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032023532
• UDI-Public: 20705032023532
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: C06060ML
• Device Lot Number: 15642766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2013
• 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
• Patient Age: 74 YR
• Patient Weight: 69