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

Catalog Number C08030SL

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

During pta with stenting 90% occluded lesion in the iliac artery with mild calcification and no vessel tortuosity, an 8x30 smart control iliac stent could not be advanced to the target lesion and upon removal it was noted that the distal tip was frayed.Another smart control stent was used instead and the procedure was successfully completed.There was no reported patient injury and the device will not be returned for analysis.The physician tried to deliver a smart control stent but it could not be advanced to the target lesion.Therefore, the physician removed the smart control stent from a patient¿s body and it was found that its distal tip was frayed.Therefore the physician stopped using the stent, and used another new smart stent was instead.The procedure was finished successfully.The access site was unknown.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The sheath introducer and guiding catheter used are unknown.It is also unknown if the diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.It is also unknown if any unusual force was used at any time during the procedure.It is also unknown if any difficulty was experienced during removal of the device or if any force was required during removal.

Manufacturer Narrative

(b)(4).(b)(6).This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

During pta (percutaneous transluminal angioplasty) with stenting 90% occluded lesion in the iliac artery with mild calcification and no vessel tortuosity, an 8x30 smart control iliac stent could not be advanced to the target lesion and upon removal it was noted that the distal tip was frayed.Another smart control stent was used instead and the procedure was successfully completed.There was no reported patient injury.The physician tried to deliver a smart control stent but it could not be advanced to the target lesion.Therefore, the physician removed the smart control stent from the patient¿s body and it was found that its distal tip was frayed.Therefore the physician stopped using the stent, and used another new smart stent instead.The procedure was finished successfully.The access site was unknown.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The sheath introducer and guiding catheter used are unknown.It is also unknown if the diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.It is also unknown if any unusual force was used at any time during the procedure.It is also unknown if any difficulty was experienced during removal of the device or if any force was required during removal.The device was not returned for analysis.A device history record (dhr) review of lot 17218348 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip - smart/flexstent/smart control/precise-frayed/split/torn-in patient (peripheral)¿ and ¿stent delivery system (sds)-tracking difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of mild calcification and a rate of stenosis of 90% may have contributed to the reported event.According to the ifu the user should, after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: stent placement is not indicated if the primary angioplasty is not technically successful.A technically successful angioplasty is one in which the guidewire and dilation catheter are passed through the lesion and dilatation of the lesion produces a lumen adequate to accommodate introduction of a csi.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported burst; therefore, no corrective/preventive action will be taken.

• 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: 4874250
• MDR Text Key: 6258619
• Report Number: 9616099-2015-00254
• 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: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: C08030SL
• Device Lot Number: 17218348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1