MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL NITINOL STENT SYSTEM; SELF EXPANDING STENTS (FGE)

Catalog Number C10040MV

Device Problems Material Frayed (1262); Premature Activation (1484); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Unknown guiding catheter, unknown guidewire, (b)(6).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Event Description

During a stenting procedure with a smart control to the superficial femoral artery, it was reported that when pushing the stent delivery system (sds) through the lesion, the surgeon felt resistance.Three trails were done, but failed to pass the lesion.So, the surgeon decided to use another product and the operation was successfully completed.There was no report of patient injury.The product looked normal when removed from its packaging.The device was properly prepped.Approach was made from the femoral artery.The guiding catheter was in place and the sv5 guide wire went through the lesion.Angiography revealed 50% stenosis of both lower extremities and the need for stent implantation.No other anomalies were noted when the device was removed from the patient.The product will be returned for analysis.Per preliminary visual analysis, the device was received with kink at 5cm from strain and stent protruding 2cm.Per the account, it is unknown if the stent prematurely deployed in the patient, or post procedure by the staff or while packaging the device to be return for analysis.

Manufacturer Narrative

Complaint conclusion: a report was received that the stent delivery system (sds) of a 10 x 40mm 120cm smart control vascular was unable to cross the target lesion.The device was exchanged and the procedure successfully completed with no reported patient injury.The event involved a (b)(6) year old male patient who was undergoing percutaneous endovascular treatment of a target lesion in his superficial femoral artery.Diagnostic angiography revealed 50% stenosis in both lower extremities and the need for ¿stent implantation¿.The patient¿s vasculature was accessed form the femoral artery, a guide catheter advanced and the target lesion crossed with a non-cordis guidewire.The site reported that the sds device appeared normal when it was removed from its¿ packaging and had been prepped properly.While advancing the smart control sds, the physician experienced resistance.Despite this resistance, he is reported to have attempted to cross the target lesion with the device three times but was still unsuccessful.No anomalies were noted on the sds when it was removed from the patient.The procedure was successfully completed with another device with no reported patient injury.Preliminary review of the returned product noted a kink 5cm from the strain relief and a 2cm of the stent protruding.The site reported that this damage had not occurred while the sds was in the patient, after the procedure or during its¿ packaging for return to the manufacturer.Further analysis of the product revealed a frayed brite tip.An attempt to clarify whether this damage occurred during use on the patient or during its¿ packaging for shipment back to the manufacturer has been unsuccessful.A non-sterile unit of pkg assay 10x040 smart vas120cm was received inside of a plastic bag.The locking pin was not received in the handle and the stent was partially deployed.In addition, a kink and bent condition was observed at 90cm and 115cm from the distal tip.Dried blood residuals were observed on the catheter.The outer diameter of the outer sheath and the usable length were found to be within specification.The catheter was inspected under the vision system and a frayed condition was noted on the brite tip.No damages were observed on the stent when it was deployed.Sem analysis of the frayed brite tip revealed evidence of elongation at the areas surrounding the frayed/split condition.Elongations can suggest an application of stress that exceeds the material yield strength and are common characteristics of pieces which were stretched/ pulled until separation.No other issues were found during sem analysis.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 could not be evaluated due to the nature of the complaint.The observed ¿sds ¿ deployment difficulty-partial deployment¿ and ¿catheter tip ¿ frayed/split/torn¿ events were confirmed based on the results of the visual and sem analysis.The cause of these events could not be conclusively determined.However the results of the sem analysis appear to suggest that procedural factors may have contributed to them.The product instructions for use (ifu) instructs the user that if resistance is met during sds 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 available for review, there are procedural factors (repeated attempts to cross the lesion after resistance) that may have contributed to the reported events.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.

• Brand Name: SMART CONTROL 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: 5451279
• MDR Text Key: 38700214
• Report Number: 9616099-2016-00090
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021898
• 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,Followup
• Report Date: 01/10/2016

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: 10/31/2016
• Device Catalogue Number: C10040MV
• Device Lot Number: 17119136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2016
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 75