MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Catalog Number PC1040RXC

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot (17666761) presented no issues during the manufacturing process that can be related to the reported event.  additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during a carotid stenting procedure the precise pro rx catheter split apart while trying to position the stent device in the tranverse venous sinus.The entire device was able to be removed and another catheter was used.There was no reported patient injury.The device was stored and handled per the ifu.There were no anomalies noted during or after the device was prepped.There were no kinks or other damages noted prior to inserting the product into the patient.The device was not used for treatment of a chronic total occlusion.The device was easily removed from the patient intact (in one piece).Then, a new precise stent was reinserted and deployed with no difficulty.The procedure was finished successfully.

Manufacturer Narrative

During a carotid stenting procedure, the precise pro rx catheter split apart while trying to position the stent in the transverse venous sinus.The entire device was able to be removed and another catheter was used.There was no reported patient injury.The device was stored and handled per the ifu.There were no anomalies noted during or after the device was prepped.There were no kinks or other damages noted prior to inserting the product into the patient.The device was not used for treatment of a chronic total occlusion.The device was easily removed from the patient intact (in one piece).Then, a new precise stent was reinserted and deployed with no difficulty.The procedure was finished successfully.One non-sterile unit of a precise pro rx us carotid syst was received for analysis coiled inside a plastic bag.Per visual analysis, the outer member was received separated at 20 cm from distal end.The stent was received inside the unit (not deployed).Sem analysis was performed to the separation on the sheath outer member with the following results: the separated sections of precise pro rx outer and inner member presented elongations and frayed edges.These characteristics present are evident of an application of a tension force that induced the separation.A device history record (dhr) review of lot (17666761) 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- separated - in patient¿ was confirmed due to the separated condition of unit received.The exact cause of the separated condition of unit could not be conclusively determined neither by sem nor by product analysis.The cordis precise pro rx nitinol stent system is indicated for use in patients with atherosclerotic disease of the carotid artery(ies) who are at increased risk for surgery.Based on the information available for review, vessel characteristics (slight tortuosity and a rate of stenosis of at least 90%) or procedural factors may have contributed to the event as evidenced by damage noted on the outer member during analysis.According to the instructions for use ¿extract the stent delivery system from the tray.Examine the device for any damage.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.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ neither the device history record (dhr) review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6730511
• MDR Text Key: 80646609
• Report Number: 9616099-2017-01260
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: 20705032036556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17666761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/20/2017
• Supplement Dates Manufacturer Received: 07/17/2017
• Supplement Dates FDA Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2017
• 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