MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL NITINOL STENT SYSTEM; SELF EXPANDING STENTS (FGE)

Catalog Number C07100MV

Device Problems Detachment Of Device Component (1104); Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

During a stenting procedure to an unknown target lesion, it was reported that a smart control stent was not available to cross the lesion and eventually failed.There was no patient injury reported.Per the preliminary visual analysis,the device's shaft and stent were detached and not included on the product received.Per the product investigation on 3/13/2015, brite tip was observed torn and elongated, on wire lumen elongations were observed at tip end, distal tip (of the sds) was observed separated from the wire lumen and the distal tip piece was not received for analysis.On outer member a slit cut was observed at 0.3 cm from distal.Additional information was received from the account indicating that the , the correct device was returned.After the procedure, the physician deployed the stent outside the patient.No additional information is available.

Manufacturer Narrative

(b)(6).(b)(4).Complaint conclusion a report was received that a 7 x 100mm smart stent delivery system (sds) failed to cross the lesion.The device was removed with no reported patient injury.When received, the sds was received without its¿ associated stent and with a separated guidewire lumen distal tip.In addition, the radiopaque distal tip marker of the outer member was torn and elongated and the surface of the outer member had a slit in it.The site was able to confirm that they had shipped the correct device and had deployed the stent themselves once it had been removed from the patient.Attempts to get any further information have been unsuccessful.A non-sterile unit of pkg assy 7x100 smart vas120cm was received inside of a plastic bag.A kink condition was observed on outer member at 4 cm from id band.Device was received with the stent deployed.The stent and locking pin were not received.The device was inspected under vision system and a kink condition was observed on wire lumen at 0.55 cm from tip end.Brite tip was observed torn and elongated, on wire lumen elongations were observed at tip end, distal tip (of the sds) was observed separated from the wire lumen and the distal tip piece was not received for analysis.On outer member a slit cut was observed at 0.3 cm from distal.Sem analysis was performed in order to determine the cause of the damages observed on outer member, brite tip and wire lumen and the results showed that the brite tip and the outer member presented evidence of elongations and damages that could be induced by an unknown object.Wire lumen also presented elongations that could be related to stretching / pulling events until separation.No other anomalies were found during the analysis.Dimensional analysis of the od of outer member revealed that it was within specification.A review of the manufacturing records for this lot revealed that it met specification prior to release.The product instructions for use (ifu) instructs the user to inspect the packaging and product for any damage.The device should not be used if they suspect that the sterility or performance of the device has been compromised.It further instructs that if resistance is met during the introduction of the sds, the system should be withdrawn and another system used.The reported ¿stent delivery system (sds) ¿ failure to cross¿ event could not be confirmed because of the nature of the complaint.The remaining findings were confirmed through visual and microscopic analysis which revealed evidence of elongation and damage consistent with pulling and stretching of the device.Based on the information available for review, there are possible handling issues that they have contributed to these events.Neither the dhr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken.(b)(6).(b)(4).Complaint conclusion a report was received that a 7 x 100mm smart stent delivery system (sds) failed to cross the lesion.The device was removed with no reported patient injury.When received, the sds was received without its¿ associated stent and with a separated guidewire lumen distal tip.In addition, the radiopaque distal tip marker of the outer member was torn and elongated and the surface of the outer member had a slit in it.The site was able to confirm that they had shipped the correct device and had deployed the stent themselves once it had been removed from the patient.Attempts to get any further information have been unsuccessful.A non-sterile unit of pkg assy 7x100 smart vas120cm was received inside of a plastic bag.A kink condition was observed on outer member at 4 cm from id band.Device was received with the stent deployed.The stent and locking pin were not received.The device was inspected under vision system and a kink condition was observed on wire lumen at 0.55 cm from tip end.Brite tip was observed torn and elongated, on wire lumen elongations were observed at tip end, distal tip (of the sds) was observed separated from the wire lumen and the distal tip piece was not received for analysis.On outer member a slit cut was observed at 0.3 cm from distal.Sem analysis was performed in order to determine the cause of the damages observed on outer member, brite tip and wire lumen and the results showed that the brite tip and the outer member presented evidence of elongations and damages that could be induced by an unknown object.Wire lumen also presented elongations that could be related to stretching / pulling events until separation.No other anomalies were found during the analysis.Dimensional analysis of the od of outer member revealed that it was within specification.A review of the manufacturing records for this lot revealed that it met specification prior to release.The product instructions for use (ifu) instructs the user to inspect the packaging and product for any damage.The device should not be used if they suspect that the sterility or performance of the device has been compromised.It further instructs that if resistance is met during the introduction of the sds, the system should be withdrawn and another system used.The reported ¿stent delivery system (sds) ¿ failure to cross¿ event could not be confirmed because of the nature of the complaint.The remaining findings were confirmed through visual and microscopic analysis which revealed evidence of elongation and damage consistent with pulling and stretching of the device.Based on the information available for review, there are possible handling issues that they have contributed to these events.Neither the dhr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (FGE)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4619518
• MDR Text Key: 16849192
• Report Number: 9616099-2015-00128
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K021898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial
• Report Date: 02/25/2015

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: Other
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: C07100MV
• Device Lot Number: 16056873
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 03/20/2015
• Date Device Manufactured: 02/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1