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

Catalog Number C06120SV

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: sheath introducer (6f10cm terumo), guidewire (chevalier 14 floppy, fmd) and balloon catheter (4mm 2cm aviator).(b)(6).Complaint conclusion: a report was received that a 6 x 120mm smart vascular stent delivery system (sds) failed to cross the target lesion.When removed, the site reported that ¿part of the outer sheath was turned upward.¿ the device was exchanged for another smart sds and the procedure successfully completed with no reported patient injury.The event involved a female patient undergoing a percutaneous intervention of a target lesion in her right superficial femoral artery that was described as 90% stenosed, mildly calcified and moderately tortuous.The patient¿s vasculature was accessed via an ipsilateral approach with a 6f 10cm non-cordis catheter sheath introducer and the lesion crossed with a non-cordis guidewire.The lesion was evaluated with intravascular ultrasound prior to pre-dilating it with a 4mm x 2cm aviator balloon catheter without issue.The site reported that the smart sds pouch and box were inspected and no damages were observed.No damages were noted to the device when it was removed from its packaging and it was prepped according to the instructions for use (ifu).The smart sds was advanced but could not cross the target lesion.It was then removed and the lesion dilated with the same balloon catheter.When the physician was re-inserting the smart sds, he/she noted that ¿part of the outer sheath was turned upward.¿ the device was exchanged for another smart sds of the same size and the procedure successfully completed with no reported patient injury.One non-sterile smart 120/150, vascular 6mm x120mm was received with an un-deployed stent and with the hemostasis valve in a closed position.The tip of the received catheter was found to be frayed and/or split and dried blood residues were found on the catheter tip.Based on the condition of the received catheter tip it can be concluded that this damaged has no relation to the packaging process.No other issues were found.The catheter tip was inspected under a microscope and the brite tip¿s external surface revealed evidence of scratch marks and elongations at the areas surrounding the fray/spilt.Elongation is a common characteristic of pieces which were stretched/ pulled until separation.Therefore, stretching/ pulling events could have been related to these separation characteristics.The outer diameter of the outer body was measured at different locations along the length of the device and all measures were found within specification.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported "sds -failure to cross" event was not confirmed based on the results of the dimensional analysis; while the reported ¿catheter tip - damaged-in patient" was confirmed based on the visual analysis.Though the exact cause of the reported events could not be conclusively determined the evidence of elongation are suggestive that procedural and/or handling factors may have contributing to them.The product ifu instructs the user that if resistance is met during sds introduction, the system should be withdrawn and another system should be used.Based on the information available for review, there are vessel characteristics (90% stenosis) and possible procedural and/or handling factors (evidence of elongation suggestion of stretching and pulling that may have contributed to the reported event.Neither the device history record review nor the product analysis suggests that the reported event was related to the manufacturing process.Therefore, no corrective actions will be taken at this time.

Event Description

During a stenting procedure to the right superficial artery, it was reported that an aviator balloon catheter (4mm x 2cm) was inflated and a smart stent was delivered to the lesion but it could not be cross the lesion.Therefore additional dilation was conducted with the balloon catheter and the smart stent was attempted to be reinserted.However, it was found apart of outer sheath was turned upward.The physician stopped using the stent and it was changed to another smart stent (6mm x 150mm).The procedure was finished successfully and there was no reported patient injury.The physician commented there was no problem when pre-dilation was conducted.No damage was observed at its pouch and box.When the stent was taken out from its pouch there was no damage visually.The device was properly prepped.An ipsilateral anterograde approach was made from the right superficial femoral artery.A sheath introducer (6f10cm terumo) was inserted and a guidewire (chevalier 14 floppy, fmd) crossed the lesion.It is unknown if there was any difficulty accessing the lesion with a guidewire.It was measured by ivus.It is unknown if there were any anomalies noted when the device was removed from the patient.The lesion was mildly calcified and moderately tortuous.The rate of stenosis was 90%.The product will be returned for analysis.Pictures are not available.Per the failure analysis of the device received, it was noted that the tip of the received unit was found frayed/split and dried blood residues were found on the catheter tip.

• 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: 5382972
• MDR Text Key: 36517232
• Report Number: 9616099-2016-00032
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/07/2015

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: 06/30/2017
• Device Catalogue Number: C06120SV
• Device Lot Number: 17285968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 01/21/2016
• Date Device Manufactured: 07/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1