MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS (NIM)

Model Number PC0830RXC

Device Problem Fracture (1260)

Patient Problems Reocclusion (1985); No Consequences Or Impact To Patient (2199)

Event Date 09/17/2014

Event Type  Injury  

Event Description

It was reported that a precise stent was found to be fractured in half on an angiogram.The patient had a precise stent implanted as part of the sapphire study on (b)(6) 2014 in for an unspecified event.The target lesion was the common carotid artery (cca).The cca was 20mm in length, 95% stenosed and mildly calcified.At the time of the index procedure there was no difficulty or resistance during deployment of the precise stent.In 2014 (date unknown), at the six month follow up visit, the patient underwent an ultrasound, and the physician noticed that something ¿didn¿t look quite right.¿ on (b)(6) 2014, the patient had an angiogram done due to an abnormal ultrasound, on which the precise stent was shown to be fractured in half.The patient did not exhibit any signs or symptoms of an adverse event.It is unknown if intervention or treatment was provided due to the stent fracture.

Manufacturer Narrative

(b)(4).Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: approximately 6 months after having a precise stent implanted in the common carotid artery ultrasound discovered that the stent was fractured and contained in-stent stenosis.An additional covered stent was placed as treatment.Review of lot 16039364 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.At present there is no evidence to indicate whether a tapered stent, as used in this case, is more prone to fracture.With the information available and without return of the product for analysis or films of the event it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and patient factors may have contributed to the reported event.

Manufacturer Narrative

Additional information was received by the patient on (b)(6) 2014, she stated that an ultrasound was conducted at an office visit in (b)(6) 2014 and the stent fracture was noted with ¿slow blood flow.¿ she stated that the stent was fractured in half and a surgical procedure was performed on (b)(6) 2014 to treat the event.During this time, 80% in-stent restenosis and stenosis of the vessel was found.A covered cas cordis stent was placed as treatment.No further information was provided.Additional information will be submitted within 30 days upon receipt.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIM)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4169228
• MDR Text Key: 5091760
• Report Number: 9616099-2014-00654
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: PC0830RXC
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 16039364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• Date Device Manufactured: 01/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR