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

Catalog Number C06150ML

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A report was received that the distal tip of a 6 x 150mm smart sfa stent delivery system (sds) was noted to be frayed.The procedure was completed with another smart stent with no reported patient injury.The event involved a patient undergoing a percutaneous intervention in a target lesion in the superficial femoral artery.This target lesion was described as mildly calcified and non-tortuous.The site reported that there was no damage or anomalies noted when the sds was removed from its¿ packaging or during the prep of the device.The patient¿s vasculature was accessed and the smart sds advanced.The site was unable to clarify whether the sds had been inserted through a stopcock as opposed to through a hemostasis valve.At some point during the procedure, the site reported that the distal tip of the sds got stuck and that resistance was met.The device was removed intact without additional maneuvers and with no reported patient injury.Attempts to obtain additional information regarding the details of this event or to obtain procedural films have been unsuccessful.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 or films of the event, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.According to the product instructions for use (ifu), the user is instructed that if resistance is encountered at any time during the insertion procedure, they are not to force passage.Resistance may cause damage to the stent or the vessel.Users should withdraw the stent system without deploying the stent.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, procedural factors may have contributed to it.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.

Event Description

It was reported that a smart stent distal tip got stuck and resistance was felt.The stent was removed from the patient and it was noted that the tip was frayed.A new smart stent was used to complete the procedure.There was no reported patient injury.A sent-delivery system sds balloon catheter was delivered to the lesion to place a smart stent to the superficial femoral artery.The lesion was mildly calcified and not tortuous.The rate of stenosis was unknown.The product was clinically used and will not be returned for analysis.Additional information was received and there were no anomalies noted when removed from the package or during prep.The device did not separate inside the patient.A procedural cd is not available for review.It is unknown if the device was inserted through a stopcock instead of a hemostatic valve.It is unknown if excessive torquing was required.It is unknown if resistance was met while advancing the device over the guidewire.It is unknown if resistance was met while withdrawing the device.Additional information was received and it is unknown what size and brand of the sds balloon catheter was used.

• 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: 5742700
• MDR Text Key: 47969298
• Report Number: 9616099-2016-00385
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/30/2016

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: 09/30/2017
• Device Catalogue Number: C06150ML
• Device Lot Number: 17362429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2016
• Initial Date FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1