MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 10X60; STENT, ILIAC

Model Number	C10060SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During treatment of a lesion in the right common iliac artery, a 10mm x 60mm 80cm s.M.A.R.T.Control iliac self-expanding stent (ses) delivery system was delivered to the aorta over a 135cm non-cordis guidewire to adjust the implantation position.During the adjustment of the implantation position, the interventional physician was discussing the implantation position with another physician when the stent was mistakenly deployed and implanted in the abdominal aorta, extending from below the renal artery to just above the common iliac artery (cia) bifurcation.A 6f 21cm non-cordis catheter sheath introducer (csi) that was initially used for the procedure was replaced with a 7f 43cm non-cordis csi and an unknown snaring device was used to pull the stent into the 7f 43cm non-cordis csi and remove the stent successfully.As a result, a new 10mm x 60mm 80cm s.M.A.R.T.Control iliac ses delivery system was used, and the stent was successfully implanted to complete the procedure.It was reported that there was no injury to the aorta.The device was stored, handled, and prepped per the instructions for use (ifu) and there was nothing unusual about the device prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The device was delivered via an ipsilateral approach and there was no difficulty experienced while advancing the device towards the lesion.The smart control locking pin was in place during advancement; however, the locking pin was removed when adjusting the position of the device.The product was not returned for analysis.A product history record (phr) review of lot 18074641 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-premature/in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Handling and procedural factors may have contributed to the reported event.The device was successfully snared from the patient.According to the instructions for use, which are not intended as a mitigation of risk, ¿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.Note: if the locking pin is not in place, system performance may be compromised and another system should be used.¿ 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.
Event or Problem Description
As reported, during treatment of a lesion in the right common iliac artery, a 10mm x 60mm 80cm s.M.A.R.T.Control iliac self-expanding stent (ses) delivery system was delivered to the aorta over a 135cm non-cordis guidewire to adjust the implantation position.During the adjustment of the implantation position, the interventional physician was discussing the implantation position with another physician when the stent was mistakenly deployed and implanted in the abdominal aorta, extending from below the renal artery to just above the common iliac artery (cia) bifurcation.A 6f 21cm non-cordis catheter sheath introducer (csi) that was initially used for the procedure was replaced with a 7f 43cm non-cordis csi and an unknown snaring device was used to pull the stent into the 7f 43cm non-cordis csi and remove the stent successfully.As a result, a new 10mm x 60mm 80cm s.M.A.R.T.Control iliac ses delivery system was used, and the stent was successfully implanted to complete the procedure.It was reported that there was no injury to the aorta.The device was stored, handled, and prepped per the instructions for use (ifu) and there was nothing unusual about the device prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The device was delivered via an ipsilateral approach and there was no difficulty experienced while advancing the device towards the lesion.The smart control locking pin was in place during advancement; however, the locking pin was removed when adjusting the position of the device.The device was discarded and will not be returned.

• Brand Name: SMART CONTROL, ILIAC 10X60
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14792777
• Report Number: 9616099-2022-05739
• Device Sequence Number: 17354433
• Product Code: NIO
• UDI-Device Identifier: 20705032024652
• UDI-Public: (01)20705032024652(17)231130(10)18074641
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: C10060SL
• Device Catalogue Number: C10060SL
• Device Lot Number: 18074641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/23/2022
• Date Device Manufactured: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM X 60MM 80CM S.M.A.R.T. CONTROL ILIAC SES DELI; 135CM CRUISE GUIDEWIRE; 6F 21CM NON-CORDIS CATHETER SHEATH INTRODUCER (CSI; 7F43CM PARENT SHEATH; UNKNOWN SNARING DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown