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

Model Number PC0840XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, a small segment of the distal end of a precise pro stent (rx 8x40) was released prematurely during removal from its packaging and flushing.A second precise pro stent was opened to complete the procedure.Initially, digital subtraction angiography (dsa) showed severe stenosis at the beginning of the right internal carotid artery.The procedure being performed was a carotid artery stenting (cas) of the right internal carotid artery under local anesthesia.The lesion was pre-dilated with an unknown balloon and an angioguard.There was no patient injury reported.The device was not clinically used and will be returned for analysis.

Manufacturer Narrative

Complaint conclusion: prior to use for a carotid artery stenting procedure, a small segment of the distal end of a precise pro stent (rx 8x40) was released prematurely during removal from its packaging and flushing.A second precise pro stent was opened to complete the procedure.Initially, digital subtraction angiography (dsa) showed severe stenosis at the beginning of the right internal carotid artery.The procedure being performed was a carotid artery stenting (cas) of the right internal carotid artery under local anesthesia.The lesion was pre-dilated with an unknown balloon and an angioguard was used for embolic protection.There was no patient injury reported.No other information was reported.The device was returned for analysis.One non-sterile precise pro rx 8x40 stent delivery system (sds) was received for analysis inside a plastic bag.No original packaging was returned.Per visual analysis, the hemostasis valve was received partially locked/closed.The stent was received 8mm pre-deployed.The outer member tip was ripped/torn and the hypo tube rod was bent as received.However, it could not be determined if the bent condition noted could be produced during the reported event or during transportation of the returned device for analysis.No other anomalies were found.Per functional analysis, a deployment test was successfully performed despite the damaged condition of the device as received.The valve of the stent delivery system was unlocked/opened.The stent was completely deployed.Neither difficulty nor anomaly (resistance, friction, or incomplete stent deployment) was experienced during the deployment procedure.Per dimensional analysis, the usable length of the device was measured and found to be within specification.A product history record (phr) review of lot 17747380 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 delivery system (sds)-ses-deployment difficulty - premature/prior to use¿ and "outer sheath-frayed/split/torn" were confirmed due to the stent being deployed and outer member tip having ripped/torn damage.However, the cause of the stent pre-deployed condition, and the outer member tip ripped/torn damage, as well as the hypo tube rod bent damage as received could not be conclusively determined during the analysis.Per the noted damaged condition of the device as received, it could be suggested that procedural and handling factors may have contributed to the reported events.Nonetheless, the functional analysis was able to be successfully performed despite the damaged condition of the device.As per the instructions for use (ifu), which is not intended as a mitigation, ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel the pouch open and remove the tray.Without removing the device from the tray, examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.With the device in the tray, attach a stopcock to the y connection on the tuohy borst valve.With the device still in the tray, attach a 5-cc syringe filled with heparinized saline to the opened stopcock and apply positive pressure until heparinized saline weeps from the proximal end of the tuohy borst valve.Lock the tuohy borst valve.Close the stopcock attached to the tuohy borst y connection.Extract the stent delivery system from the tray.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.¿ neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken.

• 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: 8425700
• MDR Text Key: 138965703
• Report Number: 9616099-2019-02789
• 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: 04/23/2019

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: 12/31/2019
• Device Model Number: PC0840XCE
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17747380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPIDER, VIATRAC; SPIDER, VIATRAC
• Patient Age: 74 YR
• Patient Weight: 75