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

Catalog Number C06040ML

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

Patient Problem Sepsis (2067)

Event Date 02/08/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).This is one of two products involved with this event in which associated manufacturer report number is 9616099-2015-00645.The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.

Event Description

As reported, the patient was enrolled in a clinical study (b)(4) and the case number is (b)(4).Approximately seven months post stenting procedure of a smart stent and a smart control stent to the middle portion to distal portion of the right superficial femoral artery, the patient expired due to ichorrhemia.The source of the sepsis is unknown.At the time of the index procedure, the stents were implanted without any issues.The lesion was moderately calcified and mildly tortuous.The rate of stenosis was 100%.

Manufacturer Narrative

Complaint conclusion: as reported, the patient was enrolled in a clinical study japan smart pms for sfa and the case number is (b)(4).Approximately seven months post stenting procedure of a smart stent and a smart control stent to the middle portion to distal portion of the right superficial femoral artery, the patient expired due to ichorrhemia.The source of the sepsis is unknown.At the time of the index procedure, the stents were implanted without any issues.The lesion was moderately calcified and mildly tortuous.The rate of stenosis was 100%.The product was not returned for evaluation and testing.A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The etiology of the patient¿s infection and resulting sepsis are unknown.Factors that may have influenced the event include patient, procedural and lesion.However, there is not enough information to draw a clinical conclusion between the device and the event.

• 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: 5295354
• MDR Text Key: 33466899
• Report Number: 9616099-2015-00646
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: C06040ML
• Device Lot Number: 15616980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Date Device Manufactured: 07/16/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 69