MAUDE Adverse Event Report: CORDIS CORPORATION SES SMART CONTROL 8X40 120; STENT, ILIAC

Catalog Number C08040MV

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.The product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Event Description

The report received indicated that the 120 cm.Smart control 8 x 40 stent delivery system was so stiff that it did not enter the catheter during the procedure.There was no reported patient injury.Multiple attempts to obtain additional information were unsuccessful.The product was returned for inspection.The preliminary analysis of the product received indicated that the inner body was received separated and the distal tip section was not received.No other discrepancies were found.

Manufacturer Narrative

During an unknown procedure, a smart control 8x40 120 cm stent delivery system (sds) was so stiff that it did not enter the catheter.There was no reported patient injury.The device was returned for analysis.One non-sterile ses smart control 8x40 120 cm sds was received coiled inside a plastic bag.The inner body was received separated.The distal tip section was not returned.No other discrepancies were found.Per dimensional analysis the outer diameter (od) of the outer sheath was noted per specification.Per sem analysis the catheter¿s separated areas presented with material deformation (bending conditions) and evidence of elongations.The elongations noted suggest that the device was subjected to stretching/pulling events that exceeded the material yield strength prior to the separation.No other issues were noted.A review of the manufacturing documentation associated with lot 17641583 was performed and no issues were noted that were related to the reported complaint.The event "stent delivery system (sds)-ses - resistance/friction-outer sheath - during use" reported by the customer was not confirmed since the outer diameter was found within specification, the exact cause of reported event could not be conclusively determined.The events of ¿catheter tip ¿ separated¿ and ¿inner shaft ¿ separated¿ were also noted during analysis.While the cause of these events could not be conclusively determined, vessel characteristics as well as procedural and handling factors likely contributed to these events.Evidence of bending and elongation suggest that the device was subjected to excessive force.As cautioned in the instructions for use (ifu), ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or vessel.Carefully withdraw the stent system without deploying the stent.¿ neither the phr review nor the product analysis suggests that the events are related to the manufacturing process; therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SES SMART CONTROL 8X40 120
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7470023
• MDR Text Key: 106856458
• Report Number: 9616099-2018-02096
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

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 Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: C08040MV
• Device Lot Number: 17641583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Distributor Facility Aware Date: 04/10/2018
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1