MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 9X40; STENT, ILIAC

Catalog Number	C09040SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The smart control stent was used as per the instructions for use (ifu), however, it jumped about 2-centimeters (cm) and could not cover the lesion completely.The smart control was therefore replaced with a new non-cordis stent and the procedure was completed.There was no reported patient injury.The lesion was the right common iliac artery and the posterior tibial artery.The vessel level of calcification is mild.The vessel level of angulation and tortuosity is none.The device was stored and handled per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.The device was prepped according to instructions for use (ifu).There were no anomalies noted during or after the device was prepped.The product was inspected prior to use and appear to be normal.There were no kinks or other damages noted prior to inserting the product into the patient.There was no excess force used during insertion.There was no difficulty or resistance.There was no unusual force used at any time during the procedure.There was no excessive torque used during advancement or delivery of the device.There was no difficulty tracking the catheter through the vessel or lesion.It was noted that the user did not touch the shaft and kept the attention to the body¿s deflection when the stent is implanted.The device was easily removed from the patient intact (in one piece).There was no patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17762814 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)-ses deployment difficulty - inaccurate placement¿ could not be confirmed as the device was not returned for analysis, nor were procedural images provided for review.The exact cause could not be determined.Procedural factors may have contributed to the reported event as the stent can ¿jump¿ forward if all the potential energy is not removed from the stent delivery system by ensuring any slack is removed from the delivery system.According to the instructions for use, which are not intended as a mitigation of risk, ¿do not attempt to drag or reposition the stent, as this may result in unintentional stent deployment.Introduction of stent delivery system.Ensure locking pin is still in place.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.Advance the stent delivery system past the stricture site.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.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.Verify that the delivery system¿s radiopaque stent markers (leading and trailing ends) are proximal and distal to the target stricture.Ensure that the introducer sheath does not move during deployment.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.(b)(4).
Event or Problem Description
As reported, the smart control stent was used as per the instructions for use (ifu), however, it jumped about 2-centimeters (cm) and could not cover the lesion completely.The smart control was therefore replaced with a new non-cordis stent and the procedure was completed.There was no reported patient injury.The lesion was the right common iliac artery and the posterior tibial artery.The vessel level of calcification is mild.The vessel level of angulation and tortuosity is none.The device was stored and handled per the instructions for use (ifu).There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.The device was prepped according to instructions for use (ifu).There were no anomalies noted during or after the device was prepped.The product was inspected prior to use and appear to be normal.There were no kinks or other damages noted prior to inserting the product into the patient.There was no excess force used during insertion.There was no difficulty or resistance.There was no unusual force used at any time during the procedure.There was no excessive torque used during advancement or delivery of the device.There was no difficulty tracking the catheter through the vessel or lesion.It was noted that the user did not touch the shaft and kept the attention to the body¿s deflection when the stent is implanted.The device was easily removed from the patient intact (in one piece).The device will not be returned for evaluation as it was discarded in the hospital due to (b)(6).

• Brand Name: SMART CONTROL, ILIAC 9X40
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8711623
• Report Number: 9616099-2019-03030
• Device Sequence Number: 16715921
• Product Code: NIO
• UDI-Device Identifier: 20705032024416
• UDI-Public: 20705032024416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: C09040SL
• Device Lot Number: 17762814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: - OMNILINK ELITE (ABBOTT VASCULAR)
• Outcome Attributed to Adverse Event: Required Intervention