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

Model Number N/A

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: 300cm radifocus(terumo), tempo, cordis, 1.5mm radifocus, terumo, guidewire (300cm cruise, st.Jude medical), 5mm nse, (b)(4)).Initial reporter: (b)(6).(b)(4).A review of the manufacturing documentation associated with this lot was performed and the following was found: review of lot 17296587 revealed no anomalies during the manufacturing and inspection processes.Six (6) defective units were rejected during the assembly of this lot.This is one of two products involved with this event in which associated manufacturer report number is 9616099-2016-00476.

Event Description

During a revascularization of a smart stent previously implanted in the distal portion of the superficial femoral artery (sfa), it was reported that a smart control stent iliac - x60ml (lot# 17296587) was delivered; however, its distal tip got stuck with struts of the former stent.The guidewire was replaced with a new one (300cm radifocus, terumo) to attempt again, but it still got stuck.After several times of attempt, it was confirmed that there was gap between the outer sheath and its tip.Furthermore as the shaft was accidentally pulled during the delivery to the lesion, and the inner shaft was exposed slightly at the distal portion.It is unknown how the procedure was completed.There was no patient injury reported.The product will be returned for analysis.The smart control was stored and handled according to the ifu.The smart control was inspected and prepped according to the instructions for use.Initially occlusion was confirmed next to a smart stent (lot# unknown).A contralateral approach was performed.An angiographic catheter (tempo, cordis) and a guidewire (1.5mm radifocus, terumo) crossed the lesion and it was changed to another guidewire (300cm cruise, st.Jude medical).A balloon (5mm nse, (b)(4)) was inflated in the stent, but the balloon ruptured due to the calcification and frayed stent.Another balloon (5mm jade, (b)(4)) was inflated next to the stent.The target lesion was heavily calcified.The rate of stenosis was unknown.The patientmedical history is unknown.

Manufacturer Narrative

Complaint conclusion: during a revascularization of a smart stent previously implanted in the distal portion of the superficial femoral artery (sfa), it was reported that a smart control stent iliac ¿ 6x60ml (lot# 17296587) was delivered; however, its distal tip got stuck with struts of the former stent.The guidewire was replaced with a new one to attempt again, but it still got stuck.After several times of attempt, it was confirmed that there was gap between the outer sheath and its tip.Furthermore as the shaft was accidentally pulled during the delivery to the lesion, and the inner shaft was exposed slightly at the distal portion.It is unknown how the procedure was completed.There was no patient injury reported.The target lesion was heavily calcified.The rate of stenosis was unknown.The patient¿s medical history is unknown.The smart control was stored and handled according to the ifu (instructions for use).The smart control was inspected and prepped according to the ifu.Initially occlusion was confirmed next to a smart stent (lot# unknown).A contralateral approach was performed.An angiographic catheter and a guidewire crossed the lesion and it was changed to another guidewire.A balloon was inflated in the stent, but the balloon ruptured due to the calcification and frayed stent.Another balloon was inflated next to the stent.The product was returned for analysis.One non-sterile smart control, iliac 6 x 60mm stent delivery system (sds) was returned.Per visual analysis the unit had not been deployed.The locking pin was in place.One kink was observed at 1.5cm from id band.No other damages were noted.Per microscopic analysis the catheter tip showed no damage.Per dimensional analysis the outer diameter (od) of the outer sheath was measured and it was found within specification.Per functional analysis the deployment process was performed without any problem.A device history record (dhr) review of lot 17296587 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds) tracking difficulty-through another stent¿, ¿stent delivery system (sds) deployment difficulty-partial deployment (peripheral)¿ and ¿catheter tip - smart/flexstent/smart control/precise frayed/split/torn-in patient (peripheral)¿ were not confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.Based on the information available for review, vessel characteristics (heavy calcification) and procedural factors may have contributed to the event as evidenced by the attempt to pass the device through a previously deployed stent and the lack of damage noted to the distal tip noted during analysis.According to the instructions for use ¿safety and effectiveness has not been demonstrated in patients with: - lesions that are either totally or densely calcified.When treating multiple lesions, the most distal lesion should be stented first followed by the stenting of proximal lesions.Stenting in this order eliminates the need to cross and reduces the chance of dislodging stents, which have already been placed.Re-crossing a stent with adjunct devices must be performed with caution to avoid stent damage or migration.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.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; 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: 5829624
• MDR Text Key: 50652710
• Report Number: 9616099-2016-00475
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: C06060ML
• Device Lot Number: 17296587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1