MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SMART CONTROL, ILIAC 10X60; STENT, ILIAC

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number: (b)(6).Resistance was felt after a 10mm x 60mm x 80cm smart control, iliac self-expanding stent (ses) system was inserted while advancing to the lesion, and the tip (the distal end) frayed.Therefore, it was replaced with a new smart stent.The lesion was the iliac artery.Initially, a.35 unknown wire crossed the lesion and an unknown balloon catheter was inflated.Then the smart control device was inserted.The temperature exposure indicator on the product pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The access site was the femoral and the site was moderately calcified.The resistance was felt while advancing to the target vessel.The 90% occluded lesion was 5cm in length with moderately calcification and moderate vessel tortuosity.The stent delivery system did not pass through any acute bends.Delivery of the sds to the lesion was contralateral.There was difficulty encountered while advancing/tracking the sds towards the lesion, but no unusual force was used at any time during insertion.The procedure was successfully completed.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17936907 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 information provided, the reported ¿catheter tip~ frayed/split/torn - in patient¿ could not be confirmed and the exact root cause could not be determined.Handling and procedural factors such as vessel characteristics (90% occluded lesion with moderate calcification and moderate vessel tortuosity) and or the user¿s interaction with the device may have led to the reported event.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
Resistance was felt after a 10mm x 60mm x 80cm smart control, iliac self-expanding stent (ses) system was inserted while advancing to the lesion, and the tip (the distal end) frayed.Therefore, it was replaced with a new smart stent.There was no reported patient injury.The lesion was the iliac artery.Initially, a.35 unknown wire crossed the lesion and an unknown balloon catheter was inflated.Then the smart control device was inserted.The temperature exposure indicator on the product pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored, handled, inspected, and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The access site was the femoral and the site was moderately calcified.The resistance was felt while advancing to the target vessel.The 90% occluded lesion was 5cm in length with moderately calcification, and moderate vessel tortuosity.The stent delivery system did not pass through any acute bends.Delivery of the sds to the lesion was contralateral.There was difficulty encountered while advancing/tracking the sds towards the lesion but no unusual force was used at any time during insertion.The procedure was successfully completed.The device will not be returned for analysis as it was discarded due to infectious disease.

• Brand Name: SMART CONTROL, ILIAC 10X60
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 10822367
• Report Number: 9616099-2020-04047
• Device Sequence Number: 14286461
• Product Code: NIO
• UDI-Device Identifier: 20705032024652
• UDI-Public: 20705032024652
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: C10060SL
• Device Lot Number: 17936907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1