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

Catalog Number PC0840XCE

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17396206) 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.

Event Description

As reported, approximately twenty-two months post stent implantation the precise pro self-expanding stent (ses) was broken.The device will not be returned for evaluation as the device remains implanted.

Manufacturer Narrative

As reported, approximately twenty-two months post stent implantation the precise pro self-expanding stent (ses) was noted to be fractured.The device remains implanted.No other information was reported.The device was not returned for analysis.Two x-ray images were provided for analysis.In both images the stent is noted to be fractured.A product history record (phr) review of lot 17396206 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿stent-ses- fractured - in patient¿ was confirmed via case image review.However, the exact cause of the damages found on device could not be conclusively determined.Procedural and handling factors may have contributed to the damages found.Because of the different nature of the joints in the neck, it is possible that significant rotational stress is put on a carotid stent as a result of movement around the atlantoaxial pivot joint as well of flexion/extension stresses by movements of the cervical vertebral joints.It can also further be deduced that because the range of neck movement is greater than the femoropopliteal segment, the forces on a given stent segment would be greater.Another important risk factor, previously not given much consideration, for stent fracture is the internal stress caused by pulsatile flow.This is thought to be higher at sites near pulsatile structures such as the heart and great vessels, and the carotid artery would certainly fit into this category.Limitations in both the flexibility and torsion of the stent will influence the long-term performance of carotid artery stenting.Per the instructions for use, which is not intended as a mitigation, ¿if resistance is met during delivery system introduction, the system should be withdrawn, and another system used.Fractures of this stent may occur.The causes and clinical implications of stent fractures are not well characterized.Care should be taken when deploying the stent as excessive force could, in rare instances, lead to stent deformation and/or fracture.¿ neither the phr review nor the case image review suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

• Brand Name: PRECISE PRO RX 8X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7766923
• MDR Text Key: 117145959
• Report Number: 9616099-2018-02302
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

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: 12/31/2017
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17396206
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1