MAUDE Adverse Event Report: CORDIS CORPORATION S.M.A.R.T. NITINOL STENT SYSTEM; SELF EXPANDING STENTS (FGE)

Catalog Number C06120ML

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, after pre-dilation the physician attempted to deliver the 120/150 smart sfa 6 x 120 stent delivery system (sds) to the target lesion but noted that the distal tip was frayed.Therefore, the physician stopped using the stent, and used another smart stent to complete the procedure successfully.There was no reported patient injury.The product was clinically used and it will not be returned for analysis.The target lesion was the superficial femoral artery (sfa).The lesion was reported to be: a 90% stenosis, moderately calcified and mildly tortuous.Additional information received indicated that the approach for the procedure was unknown.There was no reported difficulty obtaining vascular access.There was no reported difficulty advancing the device through the sheath used.It is unknown if the sheath used was a cordis product.There was no reported difficulty advancing the device towards the target lesion.The product was stored properly according to the ifu.There was no damage noted to the product packaging upon inspection prior to opening.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the instructions for use (ifu).No additional information is available.

Manufacturer Narrative

A report was received that the distal tip of a 6 x 120mm smart 120/150 stent delivery system (sds) was noted to be frayed when the physician attempted to deliver the stent.The device was removed and the procedure completed with another smart sds with no reported patient injury.The event involved a patient undergoing a percutaneous intervention of a target lesion in the superficial femoral artery.This lesion was described as 90% stenosed, moderately calcified and mildly tortuous.The patient¿s vasculature was accessed without difficulty and the lesion pre-dilated.The site reported that the smart sds had been stored, handled, inspected and prepped according to the instructions for use (ifu) and no damage was noted to the device or its¿ packaging prior to use.In addition the site reported that they had no difficulty removing the product from the packaging.No difficulty was experienced while advancing the device through the sheath or towards the target lesion.When delivering the sds towards the lesion, the physician noted that its¿ distal tip was frayed.The device was removed and the procedure completed with another smart sds with no reported patient injury.The product was not returned for analysis.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 customer complaint could not be confirmed and no determination of possible contributing factors could be made.The product ifu states that the use of this device is contraindicated in patients with highly calcified lesions.Based on the information available for review, there are vessel characteristics (calcification) that may have contributed to the reported event.Based on the device history record review, there is no indication that the event was related to the manufacturing process.Therefore, no corrective actions will be taken at this time.

• Brand Name: S.M.A.R.T. NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (FGE)
• 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: 5354636
• MDR Text Key: 35493770
• Report Number: 9616099-2016-00015
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042969
• 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,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: C06120ML
• Device Lot Number: 17118802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1