MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 7X40; STENT, CAROTID

Catalog Number PC0740XCE

Device Problem Difficult to Remove (1528)

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

Event Date 03/24/2022

Event Type  malfunction  

Event Description

As reported, the stent of a 7mm x 40mm 135cm precise pro rx self-expanding stent (ses) delivery system was stuck inside of the patient and could not be released.There was no reported injury to the patient.Additional information was requested but was not provided, and the device was not returned as expected.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18060263 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: complaint conclusion: the stent of a 7mm x 40mm 135cm precise pro rx self-expanding stent (ses) delivery system was stuck inside of the patient and could not be released.Additional information was requested but was not provided.There was no reported injury to the patient.The device was not returned for analysis.A product history record (phr) review of lot 18060263 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis the reported ¿stent delivery system (sds)-ses~ withdrawal difficulty - unable to¿ was not confirmed.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable to consider that the user¿s interaction with the device during use as well as vessel characteristics (although unknown) may have contributed to the reported event.According to 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.¿ additionally, the instructions for use (ifu) states ¿note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX 7X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14596762
• MDR Text Key: 293566718
• Report Number: 9616099-2022-05681
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032082395
• UDI-Public: (01)20705032082395(17)230930(10)18060263
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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: 09/30/2023
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 18060263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 06/15/2022
• Date Device Manufactured: 10/13/2021
• 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
• Treatment: UNKNOWN.