MAUDE Adverse Event Report: CORDIS CASHEL 7X60ML ILIAC SMART CONTROL SELF EXPANDING STENT; STENT, ILIAC

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
A 7x 60 iliac smart control self expanding stent was inserted via a right femoral artery access, but it was unable to cross the lesion between the left external iliac artery and the common femoral artery.Therefore, the lesion was inflated there with the balloon catheter.The physician attempted to deliver the smart control stent again, but the distal tip was frayed.It was replaced with a non-cordis stent.The balloon catheter was used for post-dilation.The lesion was not inflated enough slightly but good flow was confirmed.The procedure completed.The lesion was a chronic total occlusion and had severe calcification.A guidewire crossed the lesion and pre-dilatation was performed with a non-cordis balloon catheter.The sales rep cannot visit the hospital because of the covid-19.Therefore, additional information cannot be obtained.The device was discarded due to suspicious infectious disease.
Additional Manufacturer Narrative
Please note update to the udi# in section d4.A 7x 60 iliac smart control self expanding stent was inserted via a right femoral artery access, but it was unable to cross the lesion between the left external iliac artery and the common femoral artery.Therefore, the lesion was inflated there with the balloon catheter.The physician attempted to deliver the smart control stent again, but the distal tip was frayed.It was replaced with a non-cordis stent.The balloon catheter was used for post-dilation.The lesion was not inflated enough slightly but good flow was confirmed.The procedure completed.The lesion was a chronic total occlusion and had severe calcification.A guidewire crossed the lesion and pre-dilatation was performed with a non-cordis balloon catheter.The sales rep cannot visit the hospital because of the covid-19.Therefore, additional information cannot be obtained.The device was not returned for analysis.A product history record (phr) review of lot 17935149 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¿ and ¿stent delivery system (sds)-ses~ failure to cross¿ could not be confirmed.Handling and procedural factors such as vessel characteristics of a chronic total occlusion with severe calcification and or the user¿s interaction with the device may have led to the reported events.According to the instructions for use ¿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.¿ 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.

• Brand Name: 7X60ML ILIAC SMART CONTROL SELF EXPANDING STENT
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel E25 R C92; EI E25 RC92
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13595071
• Report Number: 9616099-2022-05370
• Device Sequence Number: 20098777
• Product Code: NIO
• UDI-Device Identifier: 20705032023839
• UDI-Public: 20705032023839
• 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): 03/08/2022

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: C07060ML
• Device Lot Number: 17935149
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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 GUIDEWIRE, BALLOON CATHETER 5*4 35SHIDEN HP,
• Patient Sex: Unknown