MAUDE Adverse Event Report: CORDIS US. CORP SMART CONTROL; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Catalog Number	C07150ML
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the stent of a 7mm x 150mm smart superficial femoral artery (sfa) self-expanding stent (ses) delivery system was partially deployed.The stent was able to be retrieved and removed without difficulties.There were no reported injuries to the patient.It was reported that the physician held the device by the deployment sheath during stent deployment and the stent jumped forward when attempting to release.Angiograms were performed during the procedure, but a final angiogram to confirm placement of the stent was not performed prior to attempting to release the stent.This was during a procedure to treat a lesion with severe calcification.The device was stored per the instructions for use (ifu) and will be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: the stent of a 7mm x 150mm smart superficial femoral artery (sfa) self-expanding stent (ses) delivery system was partially deployed.The stent was able to be retrieved and removed without difficulties.It was reported that the physician held the device by the deployment sheath during stent deployment and the stent jumped forward when attempting to release.Angiograms were performed during the procedure, but a final angiogram to confirm placement of the stent was not performed prior to attempting to release the stent.This was during a procedure to treat a lesion with severe calcification.The device was stored per the instructions for use (ifu).There were no reported injuries to the patient.The device was not returned for analysis.A product history record (phr) review of lot 18185296 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 ¿stent delivery system (sds)-ses~ deployment difficulty - partial deployment- in patient¿ was not confirmed.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable that procedural and or handling factors such as the user¿s interaction with the device and vessel characteristics may have contributed to the reported event.According to the instructions for use (ifu) ¿system handling ¿ precautions.Do not use if it appears to be damaged.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, the stent of a 7mm x 150mm smart superficial femoral artery (sfa) self-expanding stent (ses) delivery system was partially deployed.The stent was able to be retrieved and removed without difficulties.There were no reported injuries to the patient.It was reported that the physician held the device by the deployment sheath during stent deployment and the stent jumped forward when attempting to release.Angiograms were performed during the procedure, but a final angiogram to confirm placement of the stent was not performed prior to attempting to release the stent.This was during a procedure to treat a lesion with severe calcification.The device was stored per the instructions for use (ifu).The device will not be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18185296 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: SMART CONTROL
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17453584
• Report Number: 9616099-2023-06567
• Device Sequence Number: 7415645
• Product Code: FGE
• UDI-Device Identifier: 20705032063439
• UDI-Public: (01)20705032063439(17)250131(10)18185296
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2023

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
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: C07150ML
• Device Lot Number: 18185296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/04/2023; 09/19/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/29/2023; 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 62 KG