MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X40; STENT, CAROTID

Model Number PC0940XCE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During the implantation of the carotid precise pro stent delivery system, there was difficulty releasing the stent from the shaft in the patient body because the shaft was separated.There was no patient injury.The precise sds was replaced with another unknown stent and the procedure was completed.The operating doctor was unable to release the stent and finally decided to remove the whole system from the patient and noticed the shaft was broken and detached.

Manufacturer Narrative

Additional information was received and the anatomy is simple during the procedure.The thrombus happened one year after implantation.The thrombus was pulled back using a competitor's balloon.The lot number was also updated: iliac limb lot 17728510.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

This report is follow-up 2 but due to system limitation, this report was sent as follow up 3.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

During a carotid artery stenting procedure, there was difficulty releasing the stent from the shaft of the precise pro stent delivery system (sds).The sds was removed from the patient and was noted to be separated.There was no patient injury.The precise sds was replaced with an unknown stent and the procedure was completed.No other information was reported.The device was not returned for analysis.A product history record (phr) review of lot 17711045 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 ¿inner shaft separated - in patient¿ and ¿stent delivery system (sds)-ses deployment difficulty ¿ unable¿ could not be confirmed.The device was not retuned for analysis and procedural films were not received.The exact cause could not be determined.Vessel characteristics, as well as procedural and handling factors may have contributed to the reported event.According to the instructions for use (ifu), ¿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.If resistance is met during delivery system introduction, the system should be withdrawn, and another system used.¿ the phr review does not suggest that the failure experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

Manufacturer Narrative

Due to a system issue, the follow-up number was change to 4 in order to submit the final report.During the implantation of the carotid precise pro stent delivery system (sds), there was difficulty releasing the stent from the shaft in the patients because the shaft was separated.There was no patient injury.The precise sds was replaced with another unknown stent and the procedure was completed.The operating doctor was unable to release the stent and finally decided to remove the whole system from the patient and noticed the shaft was broken and detached.The product was returned for analysis.A non-sterile unit of precise pro rx 9x40 sds was received inside of a clear plastic bag.The part was unpacked to proceed with the product evaluation.Presence of dried blood residues could be observed on the unit.One separation condition was observed located at 23 cm from the distal tip.Elongations and frayed edges could be observed on the separated outer member of the unit.The stent of the unit was received not deployed, and the hemostasis valve was received tight closed.No other damages or anomalies were observed at the inspected device.Per microscopic analysis, the body shaft separation was observed and elongations and frayed edges characteristics were confirmed on the outer member separated sections of the unit.The elongations and frayed edges observed on the separated outer member of the unit presented evidence of an application of a tension force that induced the outer member separation.A functional test was unable to be carried out due to the separation condition observed on the outer sheath of the unit.A product history record (phr) review of lot 17711045 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¿ was confirmed due to the outer sheath separation condition of the device.The exact cause of the separated condition of the unit could not be conclusively determined during the product analysis.The reported ¿inner shaft- separated¿ was confirmed.A separation condition was observed on the device.The exact cause of the separated condition of the unit could not be conclusively determined during the product analysis.The findings in the product analysis (elongations, frayed edges and dried blood residues) indicate that the device was procedurally used and induced to an excessive application of tension force that induced the separation and possibly caused the deployment difficulty.Additionally, procedural/handling factors might have contributed to the reported events.According to the instructions for use, which is not intended as a mitigation of risk, ¿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.Note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX 9X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7970972
• MDR Text Key: 126095095
• Report Number: 9616099-2018-02446
• 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: foreign
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/09/2020

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: 07/31/2019
• Device Model Number: PC0940XCE
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17711045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 10/29/2018; 11/26/2019; 11/26/2019; 12/17/2019
• Supplement Dates FDA Received: 11/02/2018; 12/16/2019; 12/16/2019; 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1