MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 8X60; STENT, ILIAC

Model Number C08060SL

Device Problems Material Frayed (1262); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During use, it was reported that smart control stent did not cross the lesion and upon removing, the distal tip and the outer sheath were frayed.There were no patient injury.The smart control was replace with a new smart control.The stent was implanted and post dilatation was performed to complete the procedure.The lesion was the iliac artery.A contralateral approach was made from the right femoral artery with a support 6f competitor's sheathless catheter and it made a cross-over.A 0.35 competitor's guidewire crossed the lesion and an ivus confirmed the lesion.A pre dilatation was made with an unknown balloon catheter.Then a smart control stent was inserted.However it could not cross the lesion.The guidewire was exchanged to another guidewire (035 stiff) and attempted to deliver the stent several times, but it could not be delivered.The stent was removed from the patient and it was confirmed that the distal tip and the outer sheath were frayed.The device will not be returned as the device has been discarded by mistake.

Manufacturer Narrative

During use, it was reported that a 60mm x 120cm s.M.A.R.T.Control vascular stent system, did not cross the lesion in the iliac artery.Upon removing the device from the patient, the distal tip and the outer sheath were noted to be frayed.No patient injury was reported.The procedure was successfully completed with a new s.M.A.R.T.Control vascular stent system.A contralateral approach was made from the right femoral artery with the support of a 6f competitor's sheathless catheter and it made a cross-over.A 0.35 competitor's guidewire crossed the lesion and an ivus confirmed the lesion.A pre-dilatation was made with an unknown balloon catheter.Then a smart control stent was inserted.However, it could not cross the lesion.The guidewire was exchanged with another guidewire (0.35 stiff) and several unsuccessful attempts were made to deliver the stent prior to replacing the s.M.A.R.T.Control vascular stent system with a new one.The device was not returned for analysis.A product history record (phr) review of lot 17621357 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿stent delivery system (sds)-ses~failure to cross¿ could not be confirmed due to the nature of the event and the relationship to the device.The reported ¿catheter tip~frayed/split/torn - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, while unknown, and procedural/handling factors may have contributed to the reported event.Per the instructions for use, which is not intended as a mitigation ¿advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.Caution: always use an introducer sheath for the implant procedure, to protect puncture site.An introducer sheath of a 6f (2.0 mm) or larger size is recommended.¿ the phr review does not suggest that the failure experienced by the customer could be related to the manufacturing process.

• Brand Name: SMART CONTROL, ILIAC 8X60
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7638488
• MDR Text Key: 112454702
• Report Number: 9616099-2018-02213
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 20705032024157
• UDI-Public: 20705032024157
• Combination Product (y/n): N
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: C08060SL
• Device Catalogue Number: C08060SL
• Device Lot Number: 17621357
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/28/2018
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (VASSALLO FLOPPY, FILMEC)UNKNOWN GUIDE