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

Catalog Number PC0840XCE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

During a carotid artery stenting procedure, the 8x40 precise pro rx stent was unable to be released successfully and the stent delivery system was kinked.The procedure was successfully completed with another stent of the same size.No patient injury was reported.Per product analysis, the stent delivery system was received for evaluation with a separated condition at 23 cm from the distal tip.The target lesion is the opening of the carotid artery.The lesion is severely calcified, has no tortuosity, has a rate of stenosis of 70% and has a diameter of 6mm.The device was not used in a chronic total occlusion (cto).The device was stored as per the instructions for use (ifu).The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The device was prepped per the ifu and the diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was some difficulty advancing the device to the lesion.There was no unusual force used at any time during the procedure.The kink was noted after the device was inserted into the patient.No other information was reported.A 8x40 precise pro rx was received for evaluation inside of a clear plastic bag.Per visual inspection, the presence of dried blood residues was noted on the device.A separated condition was noted at 23 cm from the distal tip.Also, a kinked/bent condition was noticed at 32 cm from the distal tip.The stent was received undeployed, and the hemostasis valve was received tightly closed.No other damages or anomalies were noted.A functional test was unable to be carried out due to the separated condition of the device.Per microscopic analysis, a body shaft separation was observed under the failure analysis laboratory (fal) vision system and elongations and frayed edges were confirmed on the separated sections of the device, which presents as evidence of an application of a tension force that induced the outer member separation.A product history record (phr) review of lot 17748988 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system- deployment difficulty unable¿ could not confirmed due to the separated condition, however, it was noted that the stent had not been deployed from the received device.The reported ¿stent delivery system - kinked/bent - in patient¿ and ¿stent delivery system - separated¿ were confirmed.Kinked/bent and separated conditions were noted on the received device.The exact cause of these events could not be conclusively determined during the product analysis.Vessel characteristics such as a high degree of stenosis, as well as procedural and handling factors may have contributed to these events.As per the instructions for use, which is not intended as a mitigation, ¿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.During delivery, if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.Neither the phr review nor the product analysis suggest that the observed damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, the 8x40 precise pro rx stent was unable to be released successfully and the stent delivery system was kinked.The operation was completed with another stent of the same size.There was no effect on the patient.Additional information was received indicating that the stent was received for evaluation with a separated condition at 23 cm from the distal tip.The target lesion was the opening of the carotid artery.The lesion was severely calcified, had no tortuosity, had a rate of stenosis of 70% and had a diameter of 6mm.The device was not a chronic total occlusion (cto).The device was stored as per the instructions for use (ifu).The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The device was prepped per the ifu and the diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was some difficulty advancing the device to the lesion.There was no unusual force used at any time during the procedure.The kink was noted after the device was inserted into the patient.

• Brand Name: PRECISE PRO RX 8X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8477905
• MDR Text Key: 145115903
• Report Number: 9616099-2019-02822
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

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 Catalogue Number: PC0840XCE
• Device Lot Number: 17748988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 54