MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 6X40; STENT, CAROTID

Catalog Number PC0640XCE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/30/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18056617 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.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the stent of a 6mm x 40mm precise pro rx self-expanding stent (ses) delivery system was unable to be released and a fracture was observed on the delivery sheath of the precise pro during withdrawal of the device.There was no reported injury to the patient.Additional information was requested but was not provided.The device was returned for evaluation.Addendum: product evaluation on 13-sep-2022 revealed a separation of the inner lumen of the 6mm x 40mm precise pro rx ses.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g4, g6, h1, h2, h3, h6, and h10 complaint conclusion: the stent of a 6mm x 40mm precise pro rx self-expanding stent (ses) delivery system was unable to be released and a fracture was observed on the delivery sheath of the precise pro during withdrawal of the device.There was no reported injury to the patient.Additional information was requested but was not provided.The product was returned for analysis.A non-sterile unit of precise pro rx 6x40 was received for analysis coiled inside of a clear plastic bag.A thorough inspection was performed on the unit observing several kinks.Per visual analysis one kink is located on the hypotube approximately at 14 cm from the proximal end.Another kink is located approximately at 24 cm from the proximal end.A third kink is located approximately at 25 cm from the distal tip.Also, a separation in the outer sheath and inner lumen was observed approximately at 20.5 cm from the distal tip.The device is fully deployed, and the stent was not returned for analysis.The hemostasis valve was returned tight closed.No other damages were noted.Dimensional analysis was no performed due to the multiple kinks observed on the returned device.Functional analysis was not performed as the unit is fully deployed.However, the deploying mechanism was actuated manually, and no anomalies were observed.Per microscopic analysis the separated area presented evidence of elongations.The elongations found on the plastic material and the plastic deformation are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material was induced to a tensile force that exceeded the yield strength prior to the separation.A product history record (phr) review of lot 18056617 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 - unable¿ was not confirmed through analysis of the returned device as the unit was returned fully deployed.The exact cause of the event could not be determined during analysis.The reported ¿outer sheath cracked - in patient¿ and ¿inner shaft separated¿ were confirmed through analysis of the returned device.Based on the information available for review, procedural and/or handling factors may have contributed to the event as evidenced by elongations found on the plastic material, and the plastic deformation, are commonly associated with separations caused by material tensile overload found during analysis.According to the safety information in the instructions for use ¿note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: the mechanism for stent deployment is outer sheath retraction.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand (often referred to as the ¿pin-and-pull¿ method).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.(do not remove guidewire.)¿ neither the phr 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 at this time.

• Brand Name: PRECISE PRO RX 6X40
• 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: 15566075
• MDR Text Key: 304612695
• Report Number: 9616099-2022-06047
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062364
• UDI-Public: (01)20705032062364(17)230831(10)18056617
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: PC0640XCE
• Device Lot Number: 18056617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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