MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL NITINOL STENT SYSTEM; SELF EXPANDING STENTS (NIO)

Catalog Number C06080ML

Device Problem Occlusion Within Device (1423)

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

Event Date 01/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).This is a case from (b)(6) smart pms for superficial femoral artery (sfa) and the case number is (b)(4).As reported, a smart control, iliac 6x80ml self-expanding stent (ses) was placed at the target lesion without any issue on (b)(6) 2013, however on (b)(6) 2015 high degree restenosis was confirmed at the middle portion of the lesion under echo of below the knee (bk).The patient had non-target vessel revascularization/abscess of lung.The patient did not show any symptoms so there was no treatment and they would continue to be followed up on.On (b)(6) 2015 there was no improvement.The patient was a (b)(6) year-old female.The target lesion was at the middle portion of right superficial femoral artery.The lesion was mildly calcified and tortuous.The rate of stenosis was (b)(6).It is unknown if any distal disease was left untreated.The length of the original lesion is unknown.The original diameter of the vessel (healthy area of treated lesion site) is unknown.The original rate of stenosis is unknown.It is unknown if ¿healthy tissue to healthy tissue¿ was covered by the stent.It is unknown if the stent was post-dilated.The residual % of stenosis after stent implantation is unknown.It is unknown if the patient returned with symptoms since the last followup.It is unknown how the restenosis was found.It is unknown if the patient was on any post procedural medications.It is unknown what was done to treat the restenosis.The current status of the patient is unknown.The stent remains implanted in the patient.A device history record (dhr) review of lot 15698843 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.In-stent restenosis (isr) is often 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 prevention or cure for the progression of symptoms of coronary atherosclerotic artery disease.Stenoses or occlusion 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.No corrective or preventive action will be taken, given that; with the dhr and the information provided, the reported event does not appear to be related to the manufacturing process.

Event Description

This is a case from (b)(6) smart pms for superficial femoral artery (sfa) and the case number is (b)(4).As reported, a smart control, iliac 6x80ml self-expanding stent (ses) was placed at the target lesion without any issue on (b)(6) 2013, however on (b)(6) 2015 high degree restenosis was confirmed at the middle portion of the lesion under echo of below the knee (bk).The patient had non-target vessel revascularization/abscess of lung.The patient did not show any symptoms so there was no treatment and they would continue to be followed up on.On (b)(6) 2015 there was no improvement.The patient was a (b)(6) year-old female.The target lesion was at the middle portion of right superficial femoral artery.The lesion was mildly calcified and tortuous.The rate of stenosis was (b)(6).It is unknown if any distal disease was left untreated.The length of the original lesion is unknown.The original diameter of the vessel (healthy area of treated lesion site) is unknown.The original rate of stenosis is unknown.It is unknown if "healthy tissue to healthy tissue" was covered by the stent.It is unknown if the stent was post-dilated.The residual % of stenosis after stent implantation is unknown.It is unknown if the patient returned with symptoms since the last followup.It is unknown how the restenosis was found.It is unknown if the patient was on any post procedural medications.It is unknown what was done to treat the restenosis.The current status of the patient is unknown.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5483353
• MDR Text Key: 39768101
• Report Number: 9616099-2016-00119
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: C06080ML
• Device Lot Number: 15698843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70
• Patient Weight: 47