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

Catalog Number C08150ML

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2014

Event Type  malfunction  

Event Description

During a stenting procedure to the superficial femoral artery, it was reported that after the pre-dilatation was conducted, the physician tried to deliver a smart stent.However, it could not cross the lesion.The physician removed it from the patient and found that its distal tip was frayed.Additional information indicated that there was difficulty encountered while advancing/tracking the device towards the lesion.Therefore, the physician stopped using it and another new smart stent was used.The procedure was finished successfully and there was no patient injury reported.The device was prepared as specified by the instructions for use.There was no apparent damage to the device noticed prior to use.The smart stent did not pass through any acute bends or have to go through another stent.The target lesion was heavily calcified and the rate of stenosis is unknown.The product will not be returned for analysis.

Manufacturer Narrative

The patient's gender is unknown.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion.A report was received that during an angioplasty/stenting procedure, difficulty was experienced in crossing a lesion with an 8 x 15mm smart stent.When the device was removed, the physician noted that the distal tip to the delivery system was frayed.There was no patient injury.Details regarding the patient were not provided.The patient was underwent angioplasty/stenting of a lesion in his/her superficial artery that was described as heavily calcified.The lesion was first pre-dilated.The site reported that the device was prepped according to the instructions for use.No apparent damage was noted to the device prior to use.The site reported that difficulty was experienced when advancing the smart catheter towards the lesion but that it did not pass through any acute bends or through another previously deployed stent.Attempts to cross the lesion were unsuccessful and the device was removed.The catheter was inspected by the physician who found that its¿ distal tip was frayed.The procedure was then successfully completed with another smart stent.There was no reported patient injury.The product was not returned to the manufacturer for analysis.A review of the device history record was performed and showed that lot 15876015 met all requirements per the applicable manufacturing quality plan.The product ifu warns user that the safety and effectiveness of this device in patient with lesions that are totally or densely calcified has not been demonstrated.The ifu also instructs that if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Based on the information available for review, there are vessel characteristics (heavy calcification) and procedural factors (difficulty advancing to the vessel and failure to cross the lesion) that may have contributed to the event reported.Without the return of the device for analysis, the reported distal tip frayed/split/torn could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device 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 DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 4036418
• MDR Text Key: 19299912
• Report Number: 9616099-2014-00542
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2014

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: 04/30/2015
• Device Catalogue Number: C08150ML
• Device Lot Number: 15876015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 08/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1