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

Catalog Number C08060ML

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 12/03/2014

Event Type  Injury  

Event Description

As reported by the (b)(4) smart pms for sfa study, one year after pta with stenting involving three smart control stents, the patient had claudication.Ppi was performed 6 months was performed due to total occlusion in the stents.The patient received 2 days later.The target lesion was the middle distal of left superficial femoral artery.The rate of stenosis was 100%.

Manufacturer Narrative

(b)(4).The product remains implanted and is thus not available for analysis.Additional information is pending and will be submitted within 30 days upon receipt.This is one of 3 products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00833, 9616099-2014-00834 and 9616099-2014-00835.

Manufacturer Narrative

Additional information was received that the patient¿s admitting diagnosis prior to the stent placement is unknown.The medications are unknown.Medical history included intermittent claudication and in-stent restenosis.The diameter of the target vessel and the target lesion length are unknown.The lesion was mildly calcified with no vessel tortuosity.It is not known if the lesion was pre-dilated during the initial procedure.It is also unknown if the stents were overlapping.The original lesion is unknown, but after the patient returned, there was 100% stenosis.Additional information is pending and will be submitted within 30 days upon receipt.This is one of 3 products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00833, 9616099-2014-00834 and 9616099-2014-00835.

Manufacturer Narrative

Initial reporter's name is (b)(6).Contact information is unknown.As reported by the (b)(4), one year after pta with stenting involving three smart control stents, a 61 year-old male patient with medical history including intermittent claudication and in-stent restenosis had claudication.Ppi was performed 6 months due to total occlusion in the stents.The patient received 2 days later.The target lesion was the middle distal of left superficial femoral artery.The rate of stenosis was 100%.The patient¿s admitting diagnosis prior to the stent placement is unknown.The medications are unknown.The diameter of the target vessel and the target lesion length are unknown.The lesion was mildly calcified with no vessel tortuosity.It is not known if the lesion was pre-dilated during the initial procedure.It is also unknown if the stents were overlapping.The stenosis of the original lesion is unknown, but after the patient returned, there was 100% stenosis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.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.There is no information to suggest that there is a design or manufacturing related issue, therefore, no corrective action will be taken.This is one of 3 products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00833, 9616099-2014-00834 and 9616099-2014-00835.

• 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: 4364932
• MDR Text Key: 5237224
• Report Number: 9616099-2014-00833
• 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: Foreign,Study
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: C08060ML
• Device Lot Number: 15817156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2013
• 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
• Patient Weight: 72