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

Model Number	C08100SL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/07/2016
Type of Reportable Event	Death
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6216558
• Report Number: 9616099-2016-00822
• Device Sequence Number: 16411723
• Product Code: NIO
• UDI-Device Identifier: 20705032024256
• UDI-Public: 20705032024256
• Combination Product (Y/N): N
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Distributor Facility Aware Date: 12/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 01/09/2017; 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death