MAUDE Adverse Event Report: CORDIS CORPORATION S.M.A.R.T. NITINOL STENT SYSTEM; SELF EXPANDING STENTS (FGE)

Catalog Number C06150ML

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant devices: sheath introducer (6f 45cm destination, terumo).Guidewire (0.035 gw radifocus, terumo).(b)(6).During an interventional procedure, a smart stent could not be deployed.It was replaced with a new unidentified stent and the procedure was successfully completed.After the device was removed it was noted that the tip, the stent and the inner shaft had been dragged into the outer sheath.The stent was properly used.There was no reported patient injury.The target lesion was the left superficial femoral artery.The lesion was heavily calcified and not tortuous.The rate of stenosis was 99%.The back-up was performed with a sheath introducer from the right inguinal region.After a guidewire (0.035¿) crossed the stenosis, a balloon was inflated as a pre-dilation.A smart control was advanced to the lesion; however, it could not deploy the stent.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.It is unknown if delivery of the sds (stent deliver system) to the lesion was ipsilateral or contralateral, if there was any difficulty encountered while advancing/tracking the sds towards the lesion, if any unusual force was used at any time during the procedure, if there was thrombus present proximal to, at, or distal to the lesion site, if the sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment, if there was any difficulty experienced when removing the device and if any excessive force was needed.The device was removed intact upon removal from the patient.The product was returned for analysis.A non-sterile unit of smart 120 150, sfa - 6x150mm sds was returned.Per visual analysis the hemostasis valve was received open.The inner member was received retracted.The unit was not deployed.A damaged condition (frayed/split) was observed on the brite tip.Blood residues were noted on the device.No other anomalies or damages were noted.Per functional analysis the deployment process was performed without difficulty and the unit was successfully deployed.Because the functional analysis was performed successfully, the dimensional analysis was not performed.Per sem analysis evidence of elongations and ragged edges at the surrounding areas of the frayed/split condition was found on the brite tip.Elongations and ragged edges 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 device history record (dhr) review of lot 17393265 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) damaged-in patient¿ and ¿catheter tip - smart/flexstent/smart control/precise frayed/split/torn - (peripheral)¿ were confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural and handling factors may have contributed to the burst as evidenced by elongations and ragged edges indicative of an application of applied stress or force that exceeds the material yield strength as noted during analysis.The reported ¿stent delivery system (sds) deployment difficulty-unable¿ was not confirmed through analysis of the returned device as the device was deployed successfully during analysis.According to the instructions for use ¿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 to the lesion site.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Unlock the tuohy borst valve connecting the inner shaft and outer sheath of the delivery system.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.While using fluoroscopy, maintain position of the radiopaque stent markers relative to the targeted lesion site.Watch for the distal radiopaque markers to begin separating.Separation of the distal stent markers signals that the stent is unsheathed.Continue deploying the stent until the distal end of the stent obtains full apposition with the vessel wall.Continue deploying the stent until the proximal end of the stent obtains full apposition with the vessel wall.¿ 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.

Event Description

During an interventional procedure, a smart stent could not be deployed.It was replaced with a new unidentified stent and the procedure was successfully completed.Analysis of the device indicated the brite tip was frayed after the device was removed it was observed that the tip, the stent and the inner shaft have been dragged into the outer sheath.The stent was properly used.There was no reported patient injury.The product was clinically used.And it will be returned for analysis.The target lesion was the left superficial femoral artery.The lesion was heavily calcified and not tortuous.The rate of stenosis was 99%.The back-up was performed with a sheath introducer (6f 45cm destination, terumo) from the right inguinal region.After a guidewire (0.035 gw radifocus, terumo) was crossed the stenosis, a balloon inflated as a pre-dilation.A smart control was advanced to the lesion; however, it could not deploy the stent.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.It is unknown if delivery of the sds to the lesion ipsilateral or contralateral, if there was any difficulty encountered while advancing/tracking the sds towards the lesion, if any unusual force was used at any time during the procedure, if there was thrombus present proximal to, at, or distal to the lesion site, if the sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment, if there was any difficulty experienced when removing the device and if any excessive force was needed.The device was removed intact upon removal from the patient.Sem results show evidence of elongations and ragged edges at the surrounding areas of the frayed/split condition found on brite tip.

• Brand Name: S.M.A.R.T. 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: 5879499
• MDR Text Key: 52292916
• Report Number: 9616099-2016-00510
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/14/2016

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: Other
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: C06150ML
• Device Lot Number: 17393265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1