MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 10X40; STENT, CAROTID

Catalog Number PC1040XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available. however, it will be submitted within 30 days upon receipt.

Event Description

As reported, the 10 x 40 precise pro rapid exchange (rx) carotid stent was failed to be released.Additional information has been obtained stating that the stent had been prematurely deployed.The procedure was completed using another stent.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The device was prepped according to the ifu.There was not anything unusual noted about the stent delivery system prior to use.The diameter of the unconstrained stent size 1-2 mm was larger than the vessel diameter.The stent delivery system passed through acute bends.The lesion was pre-dilated prior to stent implantation.The balloon and size used was cordis aviator plus 6 x 20.At ten atmospheres (atm).The stent did not expand fully with good wall apposition.The lesion was not post-dilated after stent implantation.There was no unusual force applied during deployment of the stent.There was no attempt made to re-capture it.It was removed.The device will be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.Completed using another stent.The device was stored and handled per the instructions for use (ifu).The device was prepped according to the ifu.There was not anything unusual noted about the stent delivery system prior to use.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent delivery system passed through acute bends.The lesion was pre-dilated prior to stent implantation.The balloon used was a cordis aviator plus 6 x 20, at ten atmospheres (atm).The stent did not expand fully with good wall apposition.The lesion was not post-dilated after stent implantation.There was no unusual force applied during deployment of the stent.There was no attempt made to re-capture it, it was removed.There was no reported patient injury.The product was returned for analysis.A non-sterile unit of ¿precise pro rx 10mm x 40mm¿ was received inside of a clear plastic bag.The returned part was unpacked to proceed with the product evaluation.A kinked/bent condition at the outer sheath of the unit was observed located at 43 cm from the distal end.Also, the pusher rod showed a kinked condition at 12 cm from the proximal end.The stent of the unit was not deployed, and it was returned still mounted on the device.The hemostasis valve was received tightly closed.No other damages or anomalies were observed.Functional analysis was not carried out due to the kinked condition of the pusher rod and the outer sheath.Dimensional analysis was performed to verify the correct od on the profile of the stent.Dimensional analysis results were found within specification.A product history record (phr) review of lot 17851096 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- deployment difficulty premature/in patient¿ was not confirmed.The stent of the unit was observed not deployed, and it was returned still mounted on the device.However, several kinks were observed on the unit which does not allow the unit to function properly.Functional analysis was not carried out due to the kinked condition of the pusher rod.The exact cause of the kink on the pusher rod and the damages on the outer sheath could not be conclusively determined during the product analysis.The exact cause of the reported event and the condition of the unit as received could not be conclusively determined.Procedural or handling factors may have contributed to the damages observed on the unit.The condition of the returned device does match the description of the complaint.According to the instructions for use, which are not intended as a mitigation of risk, ¿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 phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of this unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX 10X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9526772
• MDR Text Key: 199872017
• Report Number: 9616099-2019-03436
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: PC1040XCE
• Device Lot Number: 17851096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1