MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 6X150MM; SELF EXPANDING STENT

Model Number N/A

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

When the pouch of a 6 x 150 mm sfa (superficial femoral artery) smart stent was opened for use in an endovascular procedure, it was confirmed that the distal tip was frayed already.Therefore, it was not used for the procedure.It was unknown how the procedure completed.The procedure completed successfully.There was no reported patient injury.The product will not be returned for analysis.The patient¿s information was unknown.The target lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.

Manufacturer Narrative

When the pouch of a 6x150mm sfa (superficial femoral artery) smart stent was opened for use in an endovascular procedure, it was confirmed that the distal tip was frayed.Therefore, it was not used for the procedure.It was unknown how the procedure completed.The procedure completed successfully.There was no reported patient injury.The product will not be returned for analysis.The patient¿s information was unknown.The target lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The product was not returned for analysis.A device history record (dhr) review of lot 17673399 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip frayed/split/torn - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is unknown what factors may have contributed to this issue between manufacture and the customer noting the reported event.Handling factors may have contributed to the reported event as no damage to the packaging was noted.According to the instructions for use, which is not intended as a mitigation, ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.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.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.¿ 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 at this time.

Manufacturer Narrative

When the pouch of a 6x150mm sfa (superficial femoral artery) smart stent was opened for use in an endovascular procedure, it was confirmed that the distal tip was frayed already.Therefore, it was not used for the procedure.It was unknown how the procedure completed.The procedure completed successfully.There was no reported patient injury.The product will not be returned for analysis.The patient¿s information was unknown.The target lesion was unknown.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The device was a short-term loan; it was not stored in the lab.There was no damage to the packaging.The pouch was still in the inner box when stored.Additional details were requested but were not provided.The product was not returned for analysis.A device history record (dhr) review of lot 17673399 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip frayed/split/torn - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.It is unknown what factors may have contributed to this issue between manufacture and the customer noting the reported event.Handling factors may have contributed to the reported event as no damage to the packaging was noted.According to the instructions for use, which is not intended as a mitigation, ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.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.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.¿ 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 at this time.(b)(4).

Manufacturer Narrative

Additional details were received that the device was short-term loan; it was not stored in the lab.There was no damage to the packaging.The pouch was still in the inner box when stored.Additional details were requested but were not provided.Additional details are pending and will be submitted within 30 days upon receipt.

• Brand Name: SMART 120 150, SFA - 6X150MM
• Type of Device: SELF EXPANDING STENT
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 ; MX 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes FL 33014 ; EI 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7036207
• MDR Text Key: 93079779
• Report Number: 9616099-2017-01584
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2018

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: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: C06150ML
• Device Lot Number: 17673399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/27/2017
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 12/21/2017; 12/27/2017; 01/24/2018
• Supplement Dates FDA Received: 01/03/2018; 01/23/2018; 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1