MAUDE Adverse Event Report: CORDIS US CORP. SMART FLEX; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	SF10100SB
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The markers of a 10mm x 100mm 80cm biliary smart flex ses (self-expanding stent) delivery system were not able to be visualized under fluoroscopy.The markers were not missing.The device did go inside the patient but because of the inability to see the markers, the stent was not deployed.A non-cordis stent was used as replacement.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 291262 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 ¿marker band ¿ inadequate radiopacity¿ was not confirmed.It is difficult to draw a clinical conclusion between the device and the events based on the information available.According to the instructions for use (ifu) ¿system handling ¿ precautions.Do not use if it appears to be damaged.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, the markers of a 10mm x 100mm 80cm biliary smart flex ses (self-expanding stent) delivery system were not able to be visualized under fluoroscopy.The markers were not missing.The device did go inside the patient.Because of the inability to see the markers, the stent was not deploy.The device did go inside the patient.A non-cordis stent was used as replacement.There was no reported patient injury.The complaint device was discarded, therefore, it is not available for evaluation.Additional event details were requested, however, not provided.

• Brand Name: SMART FLEX
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 15 christopher way; eatontown, new jersey 07724 ; 7863138372
• MDR Report Key: 17231939
• Report Number: 3005089785-2023-00129
• Device Sequence Number: 7063882
• Product Code: NIP
• UDI-Device Identifier: 20705032065785
• UDI-Public: (01)20705032065785(17)240422(10)291262
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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: 04/22/2024
• Device Catalogue Number: SF10100SB
• Device Lot Number: 291262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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.
• Patient Sex: Unknown