MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 10X30; STENT, ILIAC

Model Number	C10030SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
During use, it was reported that the smart control stent was inaccurately placed.There was no patient injury.The lesion was the subclavian artery with stenosis.A brachial approach was made with a 6f competitor's guiding catheter and a competitor's guidewire crossed the lesion.Then a smart control stent was delivered and implanted.However, it jumped and the stent was implanted in the distal of the lesion.There was no patient injury.
Additional Manufacturer Narrative
During use the smart control stent was inaccurately placed.There was no patient injury.The lesion was the subclavian artery with stenosis.A brachial approach was made with a 6f competitor's guiding catheter and a competitor's guidewire crossed the lesion.Then a smart control stent was delivered and implanted.However, it jumped and the stent was implanted in the distal of the lesion.There was no patient injury.The product was returned for analysis.One non-sterile smart control, iliac 10 x 30 self-expanding stent was returned.Per visual analysis the stent had been deployed.The locking pin was not returned.No anomalies were noted.Per functional analysis deployment was performed and no anomalies were noted.A product history record (phr) review of lot 17753576 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿sds - stent delivery system (sds)-ses - deployment difficulty - inaccurate placement¿ was not confirmed through analysis of the returned device.Procedural images were not provided therefore the nature and root cause of the ¿stent jumping¿ could not be ascertained.The exact cause of the event could not be determined during analysis as the stent appeared to have been successfully deployed.Based on the information available for review, vessel characteristics (subclavian artery with stenosis) or procedural factors such as not keeping the delivery system straight during positioning and deployment may have contributed to the event.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.¿ neither the phr 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 10X30
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7663988
• Report Number: 9616099-2018-02233
• Device Sequence Number: 2012142
• Product Code: NIO
• UDI-Device Identifier: 20705032024577
• UDI-Public: 20705032024577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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: 01/31/2020
• Device Model Number: C10030SL
• Device Catalogue Number: C10030SL
• Device Lot Number: 17753576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Distributor Facility Aware Date: 06/07/2018
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 06/30/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability