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

Catalog Number PC0840XCE

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

The product is being returned for analysis, however, as to date it has not been yet received.Additional information will be submitted within 30 days of received.

Event Description

During a carotid stenting procedure, it was reported that a precise pro stent fractured.No further information is known at this time.There was no adverse impact to the patient reported.The procedure was successfully completed by using another precise stent.The patient is fine.The product was stored and handled according to the ifu.Per the account representative, the device was not inspected and was damaged during shipping or receiving and physician did not notice prior to inserting into patient.Stent was not deployed because physician was not able to physically deploy due to damage to stent.He inserted the stent catheter, tried to deploy, could not, removed device and noticed the severe damage/fracture to the device.This presumes that the damage was there prior to the case.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The sds did not have to pass through a previously placed stent.It is unknown if the stent delivery system passed through any acute bends.It is unknown if the lesion was located at the carotid bifurcation.The fracture was identified by fluoro.The fractured stent did not separate.There is no information available as to the target/vessel characteristics.One device will be returned for analysis.

Manufacturer Narrative

Complaint conclusion: the site initially reported that an 8 x 40mm precise pro rx ous carotid stent delivery system (sds) fractured.The procedure was successfully completed with another precise sds with no reported patient injury.The event involved a patient undergoing endovascular treatment of a carotid artery.The site reported that the sds had been stored and handled according to the instructions for use (ifu).They further reported that they had not inspected the sds prior to use and felt that the damage had occurred during shipping and/or handling.No difficulty was experienced while advancing the sds to the target lesion and no unusual force was used at any time.Attempts to deploy the stent were unsuccessful.Under fluoroscopy, the physician noted that the device was fractured (though not separated into two pieces) and successfully removed the device intact from the patient.The procedure was completed with another precise stent with no reported patient injury.Further details regarding this event and angiographic films of the event were not available.One non-sterile precise pro rx ous carotid system, 5f, 8mm x 40mm, 135 cm was received coiled inside a plastic bag.The stent was not deployed and the hemostasis valve was received open.Per visual analysis the outer body was found separated at 22.0cm from the brite tip.No other damages were found on the received unit.Since the outer shaft was separated, functional testing was performed while holding the outer member and deployment was successful.The separated section was inspected under a microscope and elongation characteristics were found at the separated edges.Sem of the outer member revealed an external surface with evidence of elongation at the areas surrounding the separation.Elongation is a common characteristic of pieces which were stretched and/or pulled until separation.Stretching and/or pulling could have been related to these separation characteristics.Microscopic viewing of the stent revealed no damages, fractures or anomalies.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported "sds - separated-in patient (carotid)" event was confirmed based on the visual analysis.However, the cause of the separation found on the received precise could not be conclusively determined.According to the ifu, users are instructed to remove the device from the tray, users are instructed to examine the device for any damage prior to use.If the user suspects that the sterility or performance of the device has been compromised, they are instructed to not use the device.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, shipping, handling and/or procedural factors may have contributed to it.Neither the device history record review nor the product analysis suggests that the reported event was related to the manufacturing process.Therefore, no corrective actions will be taken at this time.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS
• 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: 5172459
• MDR Text Key: 29214035
• Report Number: 9616099-2015-00510
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17227243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2015
• Date Device Manufactured: 04/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1