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

Catalog Number C06040ML

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).This device is not available for testing and evaluation.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During stenting of a 90% occluded lesion in the superficial femoral artery with heavy calcification and vessel tortuosity, a smart control stent could not cross the lesion.It was removed and the outer sheath was frayed.The stent was changed to another stent to finish the procedure successfully.There was no reported patient injury.The device will not be returned for analysis.The product appeared normal when opened in the packaging.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.Additional details such as difficulty removing the device from the vessel or the sheath or guiding catheter, if any excessive force was needed for removal or resistance met during delivery system withdrawal.The brand and size of sheath and guiding catheter used in the procedure are also unknown.

Manufacturer Narrative

The site reported that they were unable to cross a target lesion with a 6 x 40mm smart control stent delivery system (sds).When removed, they noted that the outer sheath was frayed.The procedure was successfully completed with another device with no reported patient injury.The event involved a target lesion located in the superficial femoral artery that was described as 90% stenosed, heavily calcified and tortuous.The site reported that the device had been stored, handled, inspected and prepped according to the instructions for use (ifu).The sds appeared normal when it was removed from its packaging and there was nothing unusual noted about the sds prior to use.The smart control sds was advanced through the patient¿s vasculature but failed to cross the lesion.It was removed without difficulty but the site noted that the outer sheath was frayed.The product was not returned for evaluation.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.Without the return of the device for analysis, the reported event could not be confirmed and no determination of possible contributing factors could be made.According to the product ifu, this device is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 126mm in length, with a reference vessel diameter of 4 to 9mm and angiographic evidence of a patent profunda or superficial femoral artery.The safety and effectiveness of using this device has not been demonstrated in patients with lesions that are either totally or densely calcified.Based on the information available for review, there are vessel characteristics (heavily calcified and tortuous) that may have contributed to the reported event.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective actions will be taken at this time.

• 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: 5073243
• MDR Text Key: 25629146
• Report Number: 9616099-2015-00427
• 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
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: C06040ML
• Device Lot Number: 17171369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1