MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X40; STENT, CAROTID

Model Number PC0840XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the customer opened the package of the 8mm x 40mm precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system and the stent has been stripped in the tray.There was no reported patient injury.The intended procedure was carotid artery stenosis.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the instructions for use (ifu).The tuohy borst (hemostasis) valve was in the open position when received.The procedure was completed with a new precise stent.The device is expected to be returned for analysis.

Manufacturer Narrative

Complaint conclusion: the customer opened the package of the 8mm x 40mm precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system and the stent has been stripped in the tray.The intended procedure was carotid artery stenosis.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the instructions for use (ifu).The tuohy borst (hemostasis) valve was in the open position when received.The procedure was completed with a new precise stent.There was no reported patient injury.The device was returned for analysis.One non-sterile 8mm x 40mm precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system was received for analysis inside a plastic bag.Neither the mentioned tray of the unit nor the stent was returned for evaluation.Per visual analysis, the stent delivery system was already deployed (stent was not returned for analysis).The valve of the unit was received tightly closed, the hypo tube stroke rod was fully retracted, and the outer sheath was observed kinked at 5.2 cm from the distal tip and at the conjunction of the outer sheath to the id band.No other defects found on the stent delivery system.Per functional analysis, a deployment test was not performed due to the deployed condition of the unit the way it was received for evaluation.Per dimensional analysis, the usable length of the stent delivery system was measured against the precise pro rx packaging assembly, and it was found within specification.A product history record (phr) review of lot 17950286 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-deployment difficulty - premature/during prep¿ was not confirmed.The cause of the reported event could not be determined during the product analysis due to the way the unit was received for evaluation.However, the precise pro stent system was received in a complete deployed condition; neither the original packaging tray nor the stent of the unit were returned for evaluation.Additionally, the valve of the unit was received tightly closed, and the hypo tube stroke rod was fully retracted and kinked conditions on the unit could be noted.Per the instructions for use (ifu) ¿preparation of stent delivery system- caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.¿ unknown factors might have contributed to the stent premature deployment since the device did not present any obvious indication of a manufacturing defect or anomaly that could contribute to the reported event.Based on the evidence, it is reasonable to consider that the user¿s interaction with the device during device removal from the packaging tray resulted in the premature deployment.Additionally, the hemostasis valve was returned tightly closed, per analysis.Indicating that the end user manipulated the device.Previous observed conditions on the unit do not correspond to the findings reported in the complaint event description, quote: ¿precise pro rapid exchange (rx) carotid self-expanding stent (ses) delivery system and the stent has been stripped in the tray¿ and ¿the tuohy borst (hemostasis) valve was in the open position when received.¿neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX 8X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12458330
• MDR Text Key: 271056200
• Report Number: 9616099-2021-04857
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062425
• UDI-Public: (01)20705032062425(17)220531(10)17950286
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: PC0840XCE
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17950286
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1