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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION S.M.A.R.T. NITINOL STENT SYSTEM; SELF EXPANDING STENTS (FGE) Back to Search Results
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.
 
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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 Key5742700
MDR Text Key47969298
Report Number9616099-2016-00385
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K042969
Number of Events Reported1
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 Date09/30/2017
Device Catalogue NumberC06150ML
Device Lot Number17362429
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/30/2016
Initial Date FDA Received06/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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