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

Model Number PC0840XCE

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a precise pro stent (rx 8x40) fractured in vitro.There was no patient injury reported.The device was clinically used and will be returned for analysis.

Manufacturer Narrative

During an unknown procedure the precise pro stent (rx 8x40) was noted to be fractured.There was no patient injury reported.The device was stored and handled per the instructions for use.No anomalies were noted when removed from the package.No anomalies were noted during prep.No other information was provided.The device was returned for analysis.One non-sterile precise pro rx 8x40 was received for analysis inside a plastic bag.Per visual analysis, the outer member of the device was received separated at 21.8 cm from the brite tip.Also, it was noted to be kinked at 8.0 cm and at 20.0 cm from the tip.Elongations and frayed edges could be noted on the separated outer member of the device.The stent was not deployed, and the hemostasis valve was received closed.One kink was found on the shaft at 3.7 cm from the inner diameter (id) band, also presence of dried blood residues were noted on the device.No other anomalies found.Stroke length (pin-pull sds) dimensional analysis could not be performed due to the kinked and separated condition of the device as received.Functional analysis to deploy the stent of the device could not be performed due to the kinked and separated conditions of the device as received.Per microscopic analysis, the precise pro rx 8x40 body shaft separation was observed under the fal vision system and elongations and frayed edges were confirmed on the outer member separated sections of the device.The elongations and frayed edges noted on the separated outer member of the unit presented with evidence of application of a tension force that induced the outer member separation.A product history record (phr) review of lot 17727960 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 event reported as¿ stent-ses-fractured - in patient¿ was not confirmed due to the undeployed condition of the stent.However, kinks as well as an outer shaft separation were found on the device as received.While the exact cause of the kinked and separated condition of the body shaft of the device could not be conclusively determined during the product analysis, the elongations and frayed edges noted suggest that the device was subjected to excessive force.Procedural and handling factors may have contributed to the events.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 should be used, while the angioguard rx emboli capture guidewire remains in place.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand.Verify that the delivery system¿s radiopaque inner shaft markers (leading and trailing ends) are proximal and distal to the target lesion.Unlock the tuohy borst proximal valve end connecting the inner shaft and outer sheath of the delivery system.Ensure that the sheath introducer or guiding catheter does not move during deployment.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.¿ neither the phr review nor the product analysis suggests that the events are related to the manufacturing process.Therefore, no corrective or preventive 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 60 avenue; miami lakes FL 33014
• MDR Report Key: 8086915
• MDR Text Key: 128038131
• Report Number: 9616099-2018-02545
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: PC0840XCE
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17727960
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1