MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X30; STENT, CAROTID

Model Number PC0830XCE

Device Problems Difficult or Delayed Positioning (1157); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17724097 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, an 8x30 precise pro rx stent cannot be fully opened.No patient injury was reported.

Manufacturer Narrative

Code '3270' is no longer applicable.During an unknown procedure, an 8x30 precise pro rx stent could not be fully opened.Per product analysis, the stent was partially deployed.No patient injury was reported.No other information was reported.The device was returned for analysis.A non-sterile precise pro rx 8x30 was received inside of a clear plastic bag.Per visual inspection, the stent of the device was partially deployed, and the hemostasis valve was received open.Also, a kinked/bent condition was noted at 141 cm from the distal tip.No other damages or anomalies were noted.Per functional analysis, the tuohy borst valve of the stent delivery system was unlocked, and the stent deployment process was initiated by retracting the outer sheath while holding the inner shaft in a fixed position.The stent deployment was not able to be carried out successfully due to the kink in the stent delivery system.A product history record (phr) review of lot 17724097 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.The phr review does not suggest that the events reported by the customer could be related to the manufacturing process.The complaint reported by the customer as ¿stent delivery system- deployment difficulty partial deployment¿ was confirmed.During the device evaluation a partial deployment condition was noted, as well as a kink/bent condition, the exact cause of this kink could not be conclusively determined during the product analysis.Procedural and handling factors may have contributed to the kinked condition.Procedural factors and the kinked condition noted on the received device contributed to the deployment difficulty.Per the instructions for use (ifu), which is not intended as a mitigation, ¿precise® pro rx nitinol stent system is shipped with the tuohy borst valve in the open position.Care should be taken not to pre-deploy the stent.The device should be prepped in the tray.After prep, 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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.If resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used, while the angioguard® rx emboli capture guidewire remains in place.¿ neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX 8X30
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8288964
• MDR Text Key: 134494988
• Report Number: 9616099-2019-02673
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: PC0830XCE
• Device Catalogue Number: PC0830XCE
• Device Lot Number: 17724097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1