MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 7X80ML; STENT, ILIAC

Model Number	C07080ML
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: a 7 x 80 smart control iliac self-expanding stent (ses) was attempted to be delivered to the lesion, however, it was not able to cross the lesion.The device was removed from the patient and the physician noted that the distal tip was frayed.Therefore, the device was replaced with another different sized smart control self-expanding stent and the procedure was completed.An unknown guidewire crossed the lesion and a pre-dilation was performed.The intended treatment site was the iliac artery.The product was stored and handled according to the instructions for use (ifu).There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.There were no kinks nor other damages noted prior to inserting the product into the patient.The product was prepped per the instructions for use (ifu).The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.There was nothing unusual nor damages noted about the stent delivery system prior to use.Excessive force was not used when the device was removed from the packaging.There was mild tortuosity, moderate calcification, with 90% stenosis.A 35 non-cordis guidewire was used.The device was easily removed from the patient intact (in one piece).The other devices used with the product did not kink nor bend at any time.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17873861 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 and based on the limited information provided, the reported ¿catheter tip- frayed/split/torn - in patient¿ and ¿stent delivery system (sds)-ses~- failure to cross¿ could not be confirmed and the exact root cause could not be determined.Handling and or procedural factors such as vessel characteristics of mild tortuosity, moderate calcification and 90% stenosis as well as user technique may have contributed to the reported events.According to the instructions for use ¿safety and effectiveness has not been demonstrated in: lesions that are either totally or densely calcified.If resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent¿.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, a 7 x 80 smart control iliac self-expanding stent (ses) was attempted to be delivered to the lesion, however, it was not able to cross the lesion.The device was removed from the patient and the physician noted that the distal tip was frayed.Therefore, the device was replaced with another different sized smart control self-expanding stent and the procedure was completed.There was no reported patient injury.An unknown guidewire crossed the lesion and a pre-dilation was performed.The intended treatment site was the iliac artery.The product was stored and handled according to the instructions for use (ifu).There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.There were no kinks nor other damages noted prior to inserting the product into the patient.The product was prepped per the instructions for use (ifu).The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.There was nothing unusual nor damages noted about the stent delivery system prior to use.Excessive forced was not used when the device was removed from the packaging.There was mild tortuosity, moderate calcification, with 90% stenosis.A 35 non-cordis guidewire was used.The device was easily removed from the patient intact (in one piece).The other devices used with the product did not kink nor bend at any time.The device will not be returned for analysis because it was discarded at the hospital.

• Brand Name: SMART CONTROL, ILIAC 7X80ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10426634
• Report Number: 9616099-2020-03851
• Device Sequence Number: 3094423
• Product Code: NIO
• UDI-Device Identifier: 20705032023877
• UDI-Public: 20705032023877
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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: 05/31/2021
• Device Model Number: C07080ML
• Device Catalogue Number: C07080ML
• Device Lot Number: 17873861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1