MAUDE Adverse Event Report: CORDIS CASHEL SMART 120 150, SFA - 6X150MM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	C06150ML
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported by the (b)(6) for sfa study, on (b)(6) 2013, the smart stent was deployed in the target lesion without any issue.Approximately twenty-five months ((b)(6) 2015) post implantation of the smart (120 150, sfa - 6x150mm) self¿expanding stent (ses) on the proximal to the distal portion of the right femoral artery, an x-ray photo showed breakage of the smart (120 150, sfa - 6x150mm) stent, it was a type ii stent fracture.However, there was no clinical symptom reported.There was no treatment applied to the patient and the patient did not recovered.Later, three years post stent implantation during patient visit it showed that no change was confirmed on the stent and the patient.There was no x-ray photo taken at this time.Then, four years post stent implantation during another patient visit it showed that no change was confirmed on the stent and the patient.There was x-ray photo taken at this time.It was reported that the event is related to the product and to the procedure.On (b)(6) 2013, the smart stent was deployed in the target lesion without any issue.The product was not returned for analysis.A device history record (dhr) review of lot (15851087) revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent-ses fractured¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of the superficial femoral artery (sfa) may have contributed to the reported event.There are multiple factors that can contribute to stent fracture in the sfa.The sfa is a very dynamic vessel that undergoes biomechanical forces such as flexion, torsion, compression, and elongation.Studies have also revealed that nitinol stent fractures occurred in cases of multiple stents and overlap related to an abnormal stress area that is created.The cumulative length of the stented segment unequivocally has been identified as the most important determinant for material fatigue and subsequent fracture.In this case, vessel/lesion characteristics, procedural factors and/or biomechanical forces likely contributed to the reported event.According to the warnings in the safety information in the instructions for use ¿placing multiple overlapping stents in the sfa may increase the possibility of stent fracture.¿ neither the device history record (dhr) nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported by the (b)(6) for sfa study, approximately twenty-five months ((b)(6) 2015) post implantation of the smart (120 150, sfa - 6x150mm) self¿expanding stent (ses) on the proximal to the distal portion of the right femoral artery, an x-ray photo showed breakage of the smart (120 150, sfa - 6x150mm) stent, it was a type ii stent fracture.However, there was no clinical symptom reported.There was no treatment applied to the patient and the patient did not recovered.Later, three years post stent implantation during patient visit it showed that no change was confirmed on the stent and the patient.There was no x-ray photo taken at this time.Then, four years post stent implantation during another patient visit it showed that no change was confirmed on the stent and the patient.There was x-ray photo taken at this time.It was reported that the event is related to the product and to the procedure.On (b)(6) 2013, the smart stent was deployed in the target lesion without any issue.

• Brand Name: SMART 120 150, SFA - 6X150MM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 6798526
• Report Number: 9616099-2017-01328
• Device Sequence Number: 129549
• Product Code: FGE
• UDI-Device Identifier: 20705032063408
• UDI-Public: 20705032063408
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: 03/31/2015
• Device Catalogue Number: C06150ML
• Device Lot Number: 15851087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 90