MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 8X40; STENT, ILIAC

Model Number C08040SL

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

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

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

As reported by the smart pms for superficial femoral artery (sfa) study, two smart control stents (iliac 8x40, and iliac 7x100) were implanted in the target lesion without any issue.Approximately three years later, the patient started to feel pain in the left lower leg.Within a month, revascularization was performed in the target lesion due to in-stent restenosis.The patient has recovered.The patient¿s information was unknown.The target lesion was the proximal region of the left femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.No additional information is available.The product was not returned for analysis.A device history record (dhr) review of lot 15529355 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.In-stent restenosis is a well-known potential complication for this type of procedural and it listed in the ifu.In the literature, in-stent stenosis rates from 11% to 39% from 6 to 12 months after the stent placement.Rates are higher in older patient with more severe atherosclerosis and depended on the type of stenosis treated.Stenosis in stents are usually treated with intrastent pta or placement of a second stent.Progression of atherosclerotic disease is known to cause instant restenosis and does not indicate a device failure.Intra-arterial stent placement is a treatment of the disease process and it is not a preventive or cure for the progression of symptoms of atherosclerotic artery disease.There is no evidence of manufacturing issues that may have contributed to the reported event therefore; no corrective action is required at this time.There are patient and lesion characteristics that may have contributed to the reported event, specifically the risk factors for atherosclerotic disease.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the smart pms for superficial femoral artery (sfa) study, two smart control stents (iliac 8x40, and iliac 7x100) were implanted in the target lesion without any issue.Approximately three years later, the patient started to feel pain in the left lower leg.Within a month, revascularization was performed in the target lesion due to in-stent restenosis.The patient has recovered.The patient¿s information was unknown.The target lesion was the proximal region of the left femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.

• Brand Name: SMART CONTROL, ILIAC 8X40
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6791265
• MDR Text Key: 82583017
• Report Number: 9616099-2017-01316
• Device Sequence Number: 1
• Product Code: NIO
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: C08040SL
• Device Catalogue Number: C08040SL
• Device Lot Number: 15529355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2012
• 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
• Treatment: GUIDING SHEATH: 6FGUIDEWIRE: 0.014
• Patient Outcome(s): Required Intervention