MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 7X40ML; STENT, ILIAC

Model Number	C07040ML
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, an iliac 7 x 40ml smart control vascular stent jumped 2/3 of the length of the stent upon placement into the subclavian artery.A second 8mm x 30mm smart stent was then deployed to act as an anchor for the initial stent.There were no reports of patient injury.The stent was being placed in the left subclavian vein at the anastomosis of the "left jugular".The proximal marker of the stent was placed right at the jugular vein and the distal marker of the stent was placed into the "subclavian".Upon initiating deployment of the device, the stent jumped centrally into the brachiocephalic vein leaving 1/3 of the stent into the subclavian artery.Post- percutaneous transluminal angioplasty (pta) was preformed to ensure that the stent did not move centrally.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and prepped according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The target lesion vessel diameter was 5.5mm.A 6f cordis brite tip sheath was used.The diameter of the unconstrained stent was sized 1-2 mm larger than the vessel diameter.The target lesion vessel length was 3mm.There was 50% stenosis at the target lesion.The vessel was not tortuous.The stent delivery system (sds) did not pass through any acute bends.The delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The lesion was not pre-dilated prior to stent implantation.The smart control locking pin was in place during advancement towards the lesion.The locking pin was removed before attempting to deploy the smart control stent.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user held the handle of the smart control sds flat and straight outside the patient.The tantalum markers (smart control) were observed to open symmetrically.The device will not return for evaluation because it was implanted.
Additional Manufacturer Narrative
Complaint conclusion: a 7 x 40ml smart control iliac vascular stent jumped 2/3 of the length of the stent upon placement into the subclavian artery.A second 8mm x 30mm smart stent was then deployed to act as an anchor for the initial stent.The target lesion vessel diameter was 5.5mm.A 6f cordis brite tip sheath was used.The diameter of the unconstrained stent was sized 1-2 mm larger than the vessel diameter.The target lesion vessel length was 3mm.There was 50% stenosis at the target lesion.The vessel was not tortuous.There were no reports of patient injury.The stent was being placed in the left subclavian vein at the anastomosis of the "left jugular".The proximal marker of the stent was placed right at the jugular vein and the distal marker of the stent was placed into the "subclavian".Upon initiating deployment of the device, the stent jumped centrally into the brachiocephalic vein leaving 1/3 of the stent into the subclavian artery.Post- percutaneous transluminal angioplasty (pta) was performed to ensure that the stent did not move centrally.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and prepped according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The stent delivery system (sds) did not pass through any acute bends.The delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The lesion was not pre-dilated prior to stent implantation.The smart control locking pin was in place during advancement towards the lesion.The locking pin was removed before attempting to deploy the smart control stent.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The user held the handle of the smart control sds flat and straight outside the patient.The tantalum markers (smart control) were observed to open symmetrically.The product was not returned for analysis.A product history record (phr) review of lot 18009236 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 any slack in the delivery system may cause the stent to deploy beyond the intended site.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 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 nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: SMART CONTROL, ILIAC 7X40ML
• 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: 15832619
• Report Number: 9616099-2022-06113
• Device Sequence Number: 5391648
• Product Code: NIO
• UDI-Device Identifier: 20705032023792
• UDI-Public: 20705032023792
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: C07040ML
• Device Catalogue Number: C07040ML
• Device Lot Number: 18009236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• 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: 8MM X 30MM SMART STENT, 6F CORDIS BRITE TIP SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 68 KG