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

Catalog Number C08150ML

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Event Description

During a percutaneous transluminal angioplasty (pta)/stenting procedure, it was reported that after pre-dilatation was conducted with a coyote (boston scientific) balloon catheter, a 8x150mm smart stent was attempted to be placed at the target lesion.However, there was resistance and the stent could not be advanced.The physician conducted additional dilatation and the stent was advanced again, but the distal tip was frayed and kinked.Therefore, the physician stopped using the stent, and used another one to complete the procedure successfully.There was no report of patient injury.The product was clinically used and will be returned for analysis.The patient was a male but his age was unknown.The target lesion was the left superficial femoral artery with heavy calcification and moderate tortuosity.The rate of stenosis was 99%.A contralateral approach was made from the right femoral artery.After the lesion was crossed with a guidewire (command, abbott vascular/ (b)(4), st.Jude medical/ (b)(4)) and pre dilation was conducted with a balloon catheter (coyote, boston scientific), the smart stent delivery system (sds) was attempted to be placed to the target lesion.However there was a resistance and could not be advanced the stent.

Manufacturer Narrative

(b)(6).The initial reporter information, including hospital address, is unknown.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.Concomitant devices: gw: command, abbott vascular/ (b)(4), st.Jude medical/ (b)(4), coyote, boston scientific.

Manufacturer Narrative

The device was returned for analysis.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.The device was returned with the stent detached and not included.According to the affiliate, "unfortunately we have no information regarding the location of the stent.However, the stent was not implanted in the patient.".

Manufacturer Narrative

Additional information was provided by the affiliate.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored, inspected, prepped, and handled according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.A 6f parent medikit sheath introducer was used for the case.It is unknown if the diameter of the unconstrained stent was sized 1-2mm larger than the vessel diameter.It is also unknown if the stent delivery system had to pass through any acute bends or a previously placed stent and if unusual force was used at any time during the procedure.The device was removed intact from the patient but it is unknown if the device was easily removed.The product did not separate into two or more pieces.No further details could be obtained.Complaint conclusion the site reported that an 8 x 150mm 120/150 smart stent delivery system (sds) failed to cross the lesion.When removed, the sds distal tip was noted to be frayed and kinked.The device was exchanged for another sds with no reported patient injury.The event involved a male patient who was undergoing percutaneous transluminal angioplasty and stenting of a lesion in his left superficial femoral artery that was described as 99% stenosed, heavily calcified and moderately tortuous.The patient¿s vasculature was accessed with a contralateral approach from the right femoral artery and the lesion pre-dilated with a non-cordis balloon.The site reported that the device had been stored, inspected, prepped and handled according to the instructions for use (ifu).They noted that there was nothing unusual about the sds prior to use and they confirmed that black dotted pattern with the grey background was clearly visible on the package.The physician attempted to cross the lesion with an 8 x 150mm smart sds, but encountered resistance and could advance no further.The device was and additional dilation was performed.When the physician was preparing to re-advance the sds, he/she noted that the distal tip was frayed and kinked.The device was otherwise intact when removed.The procedure was successfully completed with another device with no reported patient injury.No further details regarding the patient, vessel characteristics or procedural details were available.A non-sterile unit of smart 120 150, sfa - 8x150mm was received inside of a plastic bag.The smart control was noted to have a fractured hypotube with a support member portion observed outside of the hemovalve.The catheter body had two kinks observed at 5 cm and 30 cm from the distal tip.Dried blood residuals were observed on the device.The outer diameter of the outer sheath was measured at different points and was found within specification.Inspection under vision system found that the stent, wire lumen and tip were overloaded inside of outer member.A flay or split was observed on the tip of outer member.The inner body and stent were removed from the outer member and damaged kinked and bent conditions were observed on the device due to overload.Sem analysis was required to determine the cause of the hypotube fracture and this revealed that the separation of the hypotube presented evidence of elongations on the plastic sheath of the hypotube.The wire lumen and inner member also presented evidence of elongations per plastic deformations.The condition observed on the analyzed components of the device suggests that the components had undergone tension conditions that deformed the separated section until the separation of the hypotube.No other anomalies were found during sem analysis.Sem analysis of the fray or split of the outer member tip revealed that the tip surface presented evidence of elongation at the areas surrounding the fray.Elongation is a common characteristic of pieces which were stretched/ pulled.Stretching/ pulling could have been related to these characteristic.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿stent delivery system (sds)/ failure to cross¿ event could not be evaluated due to nature of complaint; however, the unit was received kinked and outer diameter of the outer sheath was found within specification.Therefore, the cause of this event could not be conclusively determined.The reported ¿catheter tip - smart/flexstent/smart control/precise- frayed/split/torn - (peripheral)¿ event was confirmed based on the frayed condition of the outer member tip and the evidence of overload on the stent, wire lumen and tip of the outer member.The reported ¿catheter tip - smart/flexstent/smart control/precise- kinked/bent-in patient¿ event was confirmed based on the kinks found during visual inspection.The cause of the kinks on the catheter body could not be conclusively determined during the analysis.However, procedural factors may have contributed to the event based on the evidence of elongation and overload.According to the ifu, this device is contraindicated for use in patients with highly calcified lesions.If further instructs the user that the device should be withdrawn and another system used if resistance is met during the introduction of the delivery system.Based on the information available for review, there are vessel characteristics (heavy calcification and moderate tortuosity) and procedural factors (use of the device after having met resistance) that may have contributed to these events.Neither the dhr review nor the product analysis suggests that the reported events are 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: 4945948
• MDR Text Key: 6638578
• Report Number: 9616099-2015-00323
• 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,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/04/2015

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: 12/31/2016
• Device Catalogue Number: C08150ML
• Device Lot Number: 17185046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1