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 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Concomitant products: guidewire (astato, st.Jude medical).Micro catheter (prominent, tokai medical).Balloon (jackal, st.Jude medical) for pre-dilation.Unknown stent to finish the procedure.(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Event Description

During a stenting procedure to the right superficial femoral artery (sfa), it was reported that there was an attempt to place the smart stent at the lesion, but there was resistance felt and push ahead by force.Therefore additional pre-dilation was performed.When the physician tried to re-deliver the stent, it was confirmed its distal tip was frayed and got kinked.Therefore, it was exchanged for a different stent.The procedure was finished successfully and there was no patient injury reported.An ipsilateral approach was made from the right femoral artery.The lesion was crossed with a guidewire (astato, st.Jude medical) with a micro catheter (prominent, tokai medical), pre-dilation was conducted with a balloon catheter (jackal, st.Jude medical).The lesion was heavily calcified and moderately tortuous.The rate of stenosis was 100%.

Manufacturer Narrative

Additional information received indicated that the product was stored, inspected, handled and prepped per ifu.There was nothing unusual noted about the stent delivery system prior to use.It is unknown if the sds passed through a previously placed stent.It is unknown if there was difficulty removing the sds from the patient.Complaint conclusion: a site reported that they experienced difficulty advancing a 6 x 150mm 120/150cm smart stent delivery system (sds) to the target lesion despite the application of force.The sds was removed and when they were preparing to re-introduce it; they noted that the tip of the sds was frayed and had gotten kinked.The device was exchanged and procedure successfully completed with no reported patient injury.The event involved a male patient who was undergoing endovascular treatment on a target lesion in his right superficial femoral artery that was described as 100% stenosed, heavily calcified and moderately tortuous.The patient¿s vasculature was accessed via an ipsilateral approach and a non-cordis guidewire advanced across the lesion.The target lesion was the pre-dilated with a non-cordis balloon.The site reported that the sds had been stored, inspected, handled and prepped according to the instructions for use (ifu).Nothing unusual was noted about the device prior to use.While advancing to the lesion, the site reported that they experienced resistance and were unable to advance towards the lesion and/or cross the lesion despite the use of force.The smart sds was then removed and the lesion re-dilated.When the physician was preparing to re-introduce the smart sds, he/she noted that the distal tip was frayed and had become kinked.The sds was exchanged and the procedure successfully completed with no reported patient injury.A non-sterile unit of smart 120 150, sfa - 6x150mm was received inside of a plastic bag.The hypotube was received slightly bent.A bent condition was observed on the id band, two kinks were observed at 16.5cm and 107.5cm from the distal tip.The stent was not received.The outer sheath outer diameter was measured and found to be within specification.The device was inspected under the vision system and a flayed condition was observed on brite tip.Sem analysis revealed evidence of elongations at the areas surrounding the frayed/split condition found on brite tip.Elongations 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 review of the manufacturing records revealed that it met specification prior to release.The reported ¿catheter tip - smart/flexstent/smart control/precise- frayed/split/torn - (peripheral)¿ event was confirmed based on the visual analysis of the returned product.Sem analysis revealed evidence of elongations at the areas surrounding the frayed/split condition found on brite tip.Elongations can suggest an application of stress that exceeds the material yield strength and they are common characteristics of pieces which were stretched/ pulled until separation.The reported ¿stent delivery system (sds)/ resistance/friction-outer sheath¿ event was not confirmed since the outer diameter of the outer sheath was found within specification.Though the cause of this event could not be conclusively determined; the analysis appears to suggest that procedural factors may have contributed to it.The product ifu indicates that the use of the smart stent is contraindicated in patients with highly calcified lesions.The ifu further instructs 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 damage to the outer member.Based on the information available for review, there are vessel characteristics (calcification and tortuosity) and procedural factors (pushing against resistance) that may have contributed to the reported events.Neither the device history record review nor the product analysis suggests that the reported event could be related to the manufacturing process.Therefore, no corrective actions will be taken.

• 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: 5140512
• MDR Text Key: 27958182
• Report Number: 9616099-2015-00483
• 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
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/16/2015

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: 10/31/2016
• Device Catalogue Number: C06150ML
• Device Lot Number: 17119139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1