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

Model Number N/A

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.

Event Description

During a stenting procedure to the iliac artery, it was reported that the smart control stent delivery system (sds) was delivered to the lesion; however the distal tip became frayed.Therefore it was replaced with another smart control stent.There was no reported patient injury.The product will not be returned for analysis.The device was prepared as specified by the instructions for use.There was no apparent damage to the device noticed prior to use.An unknown guidewire had crossed the lesion and an unknown balloon was used for pre-dilatation.It is unknown if the device passed through any acute bends.The following information is also unknown: if there was any difficulty encountered while advancing/tracking the device towards the lesion, what access site was, if a contralateral approach was used.The lesion was mildly calcified and moderately tortuous.The rate of stenosis was 90%.Request for additional information has been made.Pictures are not available.

• 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: 5788447
• MDR Text Key: 49390774
• Report Number: 9616099-2016-00431
• 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
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: N/A
• Device Catalogue Number: C06100ML
• Device Lot Number: 17412480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1