MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 7X150MM; SMART SX ILIAC SFA (FGE)

Model Number	C07150ML
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during a superficial femoral artery (sfa) stenting procedure with an initial non-cordis stent placed at the ostium, a smart 120 150 sfa 7 x 150 mm.And a smart control iliac 6 x 40ml.Appeared to get hung up on the non-cordis stent and unsheath during advancement.After several attempts they were removed and still intact.Other smart stents were used and the outcome was good.Additional information has been requested.
Additional Manufacturer Narrative
Complaint conclusion- during a superficial femoral artery (sfa) stenting procedure with an initial non-cordis stent placed at the ostium, a smart 120 150 sfa 7 x 150 mm.And a smart control iliac 6 x 40ml.Appeared to get hung up on a non-cordis stent and unsheathed during advancement.  after several attempts they were removed and were found to still be intact.Other smart stents were used and the outcome was good.Additional information has been requested, but no further information has been provided.The products were not returned for analysis.(b)(4), a device history record (dhr) review of lot 17477184 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.(b)(4), a device history record (dhr) review of lot 17462197 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses deployment difficulty - premature/in patient - during advancement¿ could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.The presence of a previously implanted stent contributed to the reported event as described in the event description.According to the instructions for use ¿placing multiple overlapping stents in the sfa may increase the possibility of stent fracture.Recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: SMART 120 150, SFA - 7X150MM
• Common Device Name: SMART SX ILIAC SFA (FGE)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 6032174
• Report Number: 9616099-2016-00661
• Device Sequence Number: 10776873
• Product Code: FGE
• UDI-Device Identifier: 20705032063439
• UDI-Public: 20705032063439
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2017

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: 03/31/2018
• Device Model Number: C07150ML
• Device Catalogue Number: C07150ML
• Device Lot Number: 17462197
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2016
• Supplement Report FDA Received Date: 01/09/2017
• Patient Sequence Number: 1