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

Model Number C08100SL

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

Patient Problem Perforation of Vessels (2135)

Event Date 12/07/2016

Event Type  Death  

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported that after a smart control, iliac 8x100 was inserted and deployed in the bifurcation of the internal iliac artery.Within three minutes during a post-dilatation, perforation occurred and the patient was expired.An approach was made from the left femoral artery.A non cordis balloon catheter (6.0*40mm) was inserted but could not cross the lesion.Therefore, another non cordis balloon catheter (4.0*40mm) was inflated as a pre-dilatation.The target lesion was the common femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100% (cto).The product was clinically used and will not be returned for analysis.

Manufacturer Narrative

The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

It was reported that after a smart control, iliac 8x100 was inserted and deployed in the bifurcation of the internal iliac artery.Within three minutes during a post-dilatation, perforation occurred and the patient was expired.An approach was made from the left femoral artery.A non cordis balloon catheter (6.0*40mm) was inserted but could not cross the lesion.Therefore, another non cordis balloon catheter (4.0*40mm) was inflated as a pre-dilatation.The target lesion was the common femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was 100% (cto).The product was clinically used and will not be returned for analysis.The product was not returned for analysis.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.After careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.Perforation is a well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of intimal dissection during interventional procedures.There is no evidence to suggest there were any manufacturing issues that contributed to the reported event.This does not represent device malfunction.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.However, neither the dhr review nor the product analysis results suggests that the reported failures 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 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: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014
• MDR Report Key: 6216558
• MDR Text Key: 63686883
• Report Number: 9616099-2016-00822
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024256
• UDI-Public: 20705032024256
• Combination Product (y/n): N
• 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,Followup
• Report Date: 01/30/2017

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: 03/31/2018
• Device Model Number: C08100SL
• Device Catalogue Number: C08100SL
• Device Lot Number: 17471031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/07/2016
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/09/2017; 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2016
• 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): Death