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

Catalog Number C08080SL

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

As reported, during a percutaneous transluminal angioplasty (pta) the smart control 8 x 80 stent delivery system was attempted to be delivered to the intended target lesion.It was noted that the distal tip of the catheter was frayed.Therefore, the physician stopped using it, and new smart control was used instead.The procedure was finished successfully.There was no reported patient injury.The product was clinically used and it will not be returned for analysis.The target lesion was the superficial femoral artery (sfa).The lesion was reported to be: mildly calcified and not tortuous.The lesion was crossed with an unknown guidewire.Additional information has been requested.

Manufacturer Narrative

(b)(6).The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: during an angioplasty, the physician had difficulty tracking a smart control 8 x 80mm stent delivery system (sds) to the target lesion and noted that the distal tip of the sds was frayed.The device was exchanged and the procedure successfully completed with no reported patient injury.The event involved a patient undergoing angioplasty of a mildly calcified, non-tortuous lesion in the superficial femoral artery.The lesion was successfully crossed with an unknown guidewire.The site reported that the sds packaging was inspected prior to use and no damages were noted.No difficulty was experienced when removing the device from the packaging and the device was noted to be un-damaged.The product was prepped according to the instructions for use (ifu) with no problems experienced.The smart control sds was loaded on the guidewire but difficulty was experienced in tracking the device to the target lesion.The physician noted that the distal tip of the sds was frayed.It is unclear from the report whether this damage was noted after product removal or not.The procedure was completed with a similar device with no reported patient injury.The product was not returned for evaluation.A review of the manufacturing records revealed that this lot of products met specification prior to release.The product ifu 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.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.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.

Manufacturer Narrative

Additional information received indicated that the complaint product was not able to reach the intended target lesion.There was no damage noted to the product packaging upon inspection prior to opening.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the instructions for use (ifu) with no problems noted.No additional information is available.Additional information will be submitted within 30 days upon receipt.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIO)
• 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: 4613982
• MDR Text Key: 5587644
• Report Number: 9616099-2015-00125
• 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,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: C08080SL
• Device Lot Number: 17099279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1