MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 6X80ML; STENT, ILIAC

Model Number	C06080ML
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17317605 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.  however, it will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that during a procedure using a contralateral approach, the smart control stent was found to be deployed approximately 1 segment at beyond the curve par.There was no reported patient injury.The patient¿s information was unknown.The target lesion was at distal portion of the superficial femoral artery (sfa).The rate of stenosis was unknown.The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the device was taken out of the package.There was nothing unusual noted about the stent delivery system prior to use.The device was prepped per the instructions for use (ifu).There were no difficulties experienced in prepping the device.A non-cordis sheath introducer was inserted and a non-cordis guidewire was advanced to the lesion after pre-dilation.However, the guidewire was unable to be advanced due to the heavy calcification at the external iliac artery.The guidewire was exchanged for another one and re-advanced.When it was noticed that part of the smart control stent was deployed, the stent was removed from the patient¿s body.It is unknown how the procedure was completed, however it was completed successfully.The product was not clinically used and will be returned for analysis.
Additional Manufacturer Narrative
During a procedure using a contralateral approach, the smart control stent was found to be deployed approximately 1 segment at beyond the curve par.There was no reported patient injury.The patient¿s information is unknown.The target lesion was at distal portion of the superficial femoral artery (sfa).The rate of stenosis is unknown.The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the device was taken out of the package.There was nothing unusual noted about the stent delivery system prior to use.The device was prepped per the ifu.There were no difficulties experienced in prepping the device.A non-cordis sheath introducer was inserted and a non-cordis guidewire was advanced to the lesion after pre-dilation.However, the guidewire was unable to be advanced due to the heavy calcification at the external iliac artery.The guidewire was exchanged for another one and re-advanced.When it was noticed that part of the smart control stent was deployed, the stent was removed from the patient¿s body.It is unknown how the procedure was completed, however it was completed successfully.The product was returned for analysis.One non-sterile smart control, iliac 6 x 80 mm catheter was returned.Per visual analysis the locking pin was received in place and the unit was partially deployed (0.3 cm) from the distal end.Per functional analysis the unit was successfully deployed.A device history record (dhr) review of lot 17317605 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿deployment difficulty-premature/in patient¿ was not 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, vessel characteristics (heavy calcification of the iliac artery) may have contributed to the event as evidenced by the inability of the guidewire to be advanced.It appears that the calcification likely caused the stent to be exposed due to force being applied against a calcified artery.According to the instructions for use ¿do not attempt to drag or reposition the stent, as this may result in unintentional stent deployment.Introduction of stent delivery system a.Ensure locking pin is still in place.B.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.Caution: always use an introducer sheath for the implant procedure, to protect puncture site.An introducer sheath of a 6f (2.0 mm) or larger size is recommended.Slack removal a.Advance the stent delivery system past the stricture site.B.Pull back the stent delivery system until the radiopaque stent markers (leading and trailing ends) move in position so that they are proximal and distal to the target stricture.C.Ensure the device outside the patient remains flat and straight.Caution: slack in the catheter shaft, either outside or inside the patient, may result in deploying the stent beyond the target stricture site.Stent deployment a.Verify that the delivery system¿s radiopaque stent markers (leading and trailing ends) are proximal and distal to the target stricture.B.Ensure that the introducer sheath does not move during deployment.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.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.¿ the ifu is not being used as a mitigation for risk factors.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 at this time.

• Brand Name: SMART CONTROL, ILIAC 6X80ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6321787
• Report Number: 9616099-2017-00910
• Device Sequence Number: 578309
• Product Code: NIO
• UDI-Device Identifier: 20705032023570
• UDI-Public: 20705032023570
• Combination Product (Y/N): N
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: C06080ML
• Device Catalogue Number: C06080ML
• Device Lot Number: 17317605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Distributor Facility Aware Date: 01/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1