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

Catalog Number C10040SL

Device Problems Difficult or Delayed Positioning (1157); Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

During a percutaneous transluminal angioplasty (pta)/stenting procedure of the left common iliac artery, it was reported that a 10x40mm smart control stent was delivered to the lesion without pre-dilation.However, it couldn't cross the lesion.After pre-dilatation was conducted with a 7x20mm mustang, boston scientific balloon, the smart control was delivered to the lesion again but it failed to cross.Force was applied;the sds was pushed when the physician attempted to cross lesion.The physician retrieved it intact from the patient, and he found its distal tip was deformed (compressed) and outer sheath was withdrawn (pre-maturely deployed) slightly.There was no difficulty reported withdrawing the device from the patient.No additional measures were taken to retrieve the device from the patient.The device was exchanged for another new smart control (10/30mm different size) and the procedure was finished successfully.Preliminary device evaluation revealed that the distal tip was split.There was no patient injury reported.The product was clinically used and will be returned for analysis.The lesion was moderately calcified and moderately tortuous.The rate of stenosis was unknown.A retrograde approach was made from the left common femoral artery.After the lesion was crossed with a guidewire, the smart control was delivered to the lesion but couldn't cross.The tip was not found to be cracked, separated, kinked/bent, or frayed/split/torn.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the ifu.It is unknown if the product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.

Manufacturer Narrative

The diameter of the unconstrained stent was sized 1-2 mm larger than the vessel diameter.The target lesion vessel diameter and length are unknown.The sds did not have to pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.No thrombus was present proximal to, at, or distal to the lesion site.The sds did not have to pass through a previously placed stent.There was no difficulty encountered flushing the stopcock and sds.The smart control locking pin was in place during advancement towards the lesion.The user held the handle of the sds flat and straight outside the patient, as instructed in the ifu.There was no difficulty reported withdrawing the device from the patient.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: during an angioplasty and stenting procedure, a 10 x 40mm smart control stent inadvertently partially deployed.The device was removed and upon inspection, the distal tip was found to be compressed.The procedure was successfully completed with another smart control and there was no reported patient injury.The event involved a male patient of unknown age with an unknown past medical history.The left femoral artery was accessed and the procedure started via retrograde approach.No thrombus was noted in or around the lesion site.The target lesion was located in the patient¿s left common iliac and was described as moderately calcified and moderately tortuous.The lesion was crossed with the guidewire and a 10 x 40mm smart control device was opened.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The unconstrained stent was noted was 1-2mm larger than the vessel diameter.No difficulty was encountered during the flushing of the stopcock or the stent delivery system (sds).The smart control device was advanced towards the lesion with the locking pin in place.The site reported that the user held the handle of the sds flat and straight outside the patient and that the device was stored and handled according to the instructions for use (ifu).The device did not have to pass through any acute bends or through another previously deployed stent.The site did not encounter any resistance while advancing the device but did experience difficulty in crossing the lesion.The site reported that they utilized unusual force when attempting to cross the lesion with the device.Of note, the lesion was not pre-dilated prior to the advancement of the smart control device.The device was removed without difficulty and a 7 x 20mm non-cordis balloon was then used to pre-dilate the lesion.The smart control device was then re-advanced but again failed to cross the lesion.The device was again withdrawn without difficulty from the patient.Once removed, it was inspected and the distal tip was found to be compressed without kinking.In addition, the outer sheath was slightly withdrawn and the stent slightly deployed.The procedure was then successfully completed with a 10 x 30mm smart control device with no reported patient injury.One non-sterile smart control, iliac 10x40 was received coiled inside a plastic bag.Unit was not deployed.Locking pin was received loose.Catheter tip (brite tip) was received frayed.One kink was observed at 3.5cm from id band.No other discrepancies were found.The usable length and the outer diameter (od) of the outer sheath were measured and found within specification.According to procedure the functional test (deployment process) was performed without any problem.The unit was sent to sem analysis in order to analyze the potential cause of catheter tip damaged (brite tip); sem results show that the brite tip surface presented evidence of elongation at the surrounding areas of the frayed.Elongation is a common characteristic of pieces which were stretched/ pulled until separation.Stretching/ pulling could have been related to these characteristic.A review of the manufacturing documentation associated with this lot presented rejects may be potentially related to the complaint; however controls are in placed at the assembly and packaging processes to detect these kind of issues;.The rejected units were properly segregated and discarded.The cause of the "kink" condition found could not be conclusively determined; however it does not appear to be manufacturing related.Controls are in placed at the final assembly and packaging processes to detect this kind of issue (kink); ppe 10182201 rev.23 (100% inspection).The failure reported ¿catheter tip - frayed/split/torn-in patient¿ by the customer was confirmed; the cause of the failure was not conclusively determined.The failure does not appear to be manufacturing related.Neither the dhr review nor the analysis suggests that the failure is manufacturing related.During manufacturing process there are controls to detect this kind of issue ppe 10965971 rev.7 100% final inspection.Therefore no actions were taken.The failures "sds - failure to cross ¿and ¿sds - deployment difficulty-premature/in patient¿ reported by the customer were not confirmed since dimensional and functional analysis were found within specification.The cause of the failure could not be conclusively determined.Neither the dhr review nor the analysis suggests that the failure is manufacturing related.Therefore no actions were taken.The product ifu instructs that stent placement is not indicated if the primary angioplasty is not technically successful and should be assessed to determine the adequacy of the primary procedure.The ifu further details that if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Pushing the sds against resistance, which can be encountered during sds advancement through calcified, tortuous or stenotic vasculature, can cause the outer member to compress, thus contributing to premature stent deployment/stent jumping while the locking pin is still in.Based on the information for review there are vessel characteristics (moderately calcified and tortuous lesion) and procedural factors (no pre-dilation, resistance when attempting to cross the lesion and unusual force utilized, re-introduction of the sds after resistance) that may have contributed to the reported failure to cross and deployment difficulty.The product was returned and did not confirm the reported ¿sds ¿ failure to cross¿ or the ¿sds ¿ deployment difficulty-premature/in patient¿ since the device passed dimensional and functional analysis.The reported ¿catheter tip ¿ frayed/split/torn-in patient¿ was confirmed based on the microscopic analysis that was consistent with stretching and/or pulling.The exact cause of this failure cause of the failure could not be determined.Neither the dhr review nor the product analysis suggests that the reported events could be related to the manufacturing process.Therefore no corrective or preventative 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 DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 4080224
• MDR Text Key: 4739020
• Report Number: 9616099-2014-00582
• 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
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: C10040SL
• Device Lot Number: 17018169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7X20MM MUSTANG, BOSTON SCIENTIFIC BALLOON