MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 6X40; STENT, ILIAC

Model Number	C06040SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After the smart control was opened during the pta case, it deployed about 2cm.It was replaced with a new product and the procedure was completed.The lesion was in the superficial femoral artery.There was no reported injury to the patient.The device was not returned for analysis.A product history record (phr) review of lot 18013980 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis the reported ¿stent delivery system (sds)-ses~ deployment difficulty - premature/during prep¿ was not confirmed.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, it is probable that procedural and or handling factors such as the user¿s interaction with the device during use may have contributed to the reported event.According to the instructions for use (ifu), introduction of stent delivery system: ensure locking pin is still in place.Note: if the locking pin is not in place, system performance may be compromised, and another system should be used.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.
Event or Problem Description
As reported, after the smart control was opened during the pta case, it deployed about 2cm.It was replaced with a new product and the procedure was completed.There was no reported injury to the patient.The lesion was in the superficial femoral artery.The device will not be returned for evaluation.Multiple attempts were made without success to obtain the device and additional information.
Event or Problem Description
As reported, after the smart control was opened during the pta case, it deployed about 2cm.It was replaced with a new product and the procedure was completed.There was no reported injury to the patient.The lesion was in the superficial femoral artery.The device will not be returned for evaluation.Multiple attempts were made without success to obtain the device and additional information.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, d9, g3, h1, h2, h3 and h6 after the smart control was opened during the pta case, it deployed about 2cm.It was replaced with a new product and the procedure was completed.There was no reported injury to the patient.The lesion was in the superficial femoral artery.Multiple attempts were made without success to obtain the device and additional information.The product was returned for analysis.A non-sterile unit of product smart control, iliac 6x40mm was received coiled inside of a clear plastic bag.The unit was returned fully deployed and the stent was included in the shipment.Also, the locking pin was included.A kinked/bent condition was observed located approximately at 80 cm from the distal tip.The stent was inspected and no anomalies were observed on it.A product history record (phr) review of lot 18013980 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/during prep¿ was not confirmed through analysis of the returned device as the stent was fully deployed.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event although very little information was provided by the operator.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.¿ 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 6X40
• 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: 14596733
• Report Number: 9616099-2022-05680
• Device Sequence Number: 5811128
• Product Code: NIO
• UDI-Device Identifier: 20705032023518
• UDI-Public: (01)20705032023518(17)230331(10)18013980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 03/31/2023
• Device Model Number: C06040SL
• Device Catalogue Number: C06040SL
• Device Lot Number: 18013980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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: UNK DEVICE
• Patient Sex: Unknown