MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 8X60ML; STENT, ILIAC

Model Number	C08060ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	05/11/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that the patient had in-stent re-stenosis with two smart stents and a smart control stent.Plain old balloon angioplasty (poba) was performed for the edges of the lesion, inside the in-stent re-stenosis, and whole lesion.The patient recovered.Two smart stents and a smart control stent were placed in the target lesion without any issue on (b)(6) 2013.Three years later (b)(6) 2016, intermittent claudication was confirmed on the patient.The patient had an angiography examination on (b)(6) 2016, and ppi was performed.The rate of abi before ppi was 0.96 in the right and 0.48 in the left.The rate of stenosis before ppi was 50 to 99 % of stenosis.The target lesion was the distal, middle, and proximal portions of the left superficial femoral artery.The lesion was moderately calcified and not tortuous.The rate of stenosis was 100%.This is a case from (b)(6) smart pms for sfa and the case number is (b)(4).
Additional Manufacturer Narrative
It was reported that the patient had in-stent re-stenosis with two smart stents and a smart control stent.Plain old balloon angioplasty (poba) was performed for the edges of the lesion, inside the in-stent re-stenosis, and whole lesion.The patient recovered.Two smart stents and a smart control stent were placed in the target lesion without any issue on (b)(6) 2013.Three years later ((b)(6) 2016), intermittent claudication was confirmed on the patient.The patient had an angiography examination on (b)(6) 2016, and ppi was performed.The rate of abi before ppi was 0.96 in the right and 0.48 in the left.The rate of stenosis before ppi was 50 to 99 % of stenosis.The target lesion was the distal, middle, and proximal portions of the left superficial femoral artery.The lesion was moderately calcified and not tortuous.The rate of stenosis was 100%.This is a case from japan smart pms for sfa and the case number is (b)(6).Case-(b)(6) 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.Case-(b)(6) 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.Case-(b)(6) 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.In-stent restenosis (isr) is associated with the progression of atherosclerotic disease and is a known potential adverse event following stent implantation and does not represent a device failure.Intra-arterial stent placement is a treatment of the disease process, it is not a preventive or cure for the progression of symptoms of atherosclerotic artery disease.Vessel occlusion, restenosis, intimal hyperplasia or recurrent strictures are well known documented potential complications of this type of procedure and are listed in the ifu as such.In the literature, in-stent stenosis rates range from 11% to 39% from 6 to 12 months after stent placement.Rates were higher in older patients with more severe atherosclerosis and depended on the type of stenosis treated.Isr is more prevalent in ostial stent placement procedures.Stenosis in stents are usually treated with intrastent pta or placement of a second stent.Factors that may have influenced this event include patient, procedural, pharmacological and lesion.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 8X60ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6087728
• Report Number: 9616099-2016-00713
• Device Sequence Number: 16296549
• Product Code: NIO
• UDI-Device Identifier: 20705032024133
• UDI-Public: 20705032024133
• 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
• Report Date (Section B): 01/19/2017

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: 01/31/2015
• Device Model Number: C08060ML
• Device Catalogue Number: C08060ML
• Device Lot Number: 15817156
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 71