MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 7X40ML; STENT, ILIAC

Model Number	C07040ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	10/13/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product remains implanted and is thus not available 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 was implanted the smart control stent in the target lesion without any issue.Two years later, the patient had claudication on the right leg and occlusive thrombosis was confirmed in the stent.A fogarty procedure was performed the next day and the patient recovered.Three years after the procedure, the patient expired.The patient¿s death is unknown.The target lesion was the distal portion of the right superficial femoral artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.This is a case from (b)(4) smart pms for sfa and the case number is (b)(4).
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 the patient was implanted the smart control stent in the target lesion without any issue.Two years later, the patient had claudication on the right leg and occlusive thrombosis was confirmed in the stent.A fogarty procedure was performed the next day and the patient recovered.Three years after the procedure, the patient expired.The patient¿s death is unknown.The target lesion was the distal portion of the right superficial femoral artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was 99%.The length of the lesion is 20mm.There was not more than one stent placed.This is a case from (b)(4) smart pms for sfa and the case number is (b)(4).The product was not returned for analysis.A device history record review of lot 15624207 was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan and that there were no anomalies during the manufacturing.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.Stenoses in stents are usually treated with intrastent pta or placement of a second stent.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.The dhr reviews does not suggests that the reported failures could be related to the manufacturing process of the unit.Therefore no corrective action will be taken.

• Brand Name: SMART CONTROL, ILIAC 7X40ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7060435
• Report Number: 9616099-2017-01624
• Device Sequence Number: 19172018
• Product Code: NIO
• UDI-Device Identifier: 20705032023792
• UDI-Public: 20705032023792
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: C07040ML
• Device Catalogue Number: C07040ML
• Device Lot Number: 15624207
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/30/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 11/29/2017; 12/28/2017
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 11/30/2017; 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 7FRGUIDING SHEATH: 6FRGUIDEWIRE: 0.014
• Patient Weight: 54