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

Model Number PC0940XCE

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2020

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.A review of the manufacturing documentation associated with this lot# 17896171 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the delivery system of a 9 x 40 precise pro rapid exchange (rx) self-expanding stent was difficult to withdraw when the stent was released.There was no reported patient injury.The intended procedure was carotid artery stenosis (cas).The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the instructions for use.There was nothing usual noted about the stent delivery system prior to use.A non-cordis 8f sheath introducer was used.A cordis 8f guiding catheter was used.The diameter of the unconstrained stent was 1-2mm larger than the vessel diameter.The device was prepped in the tray.The tuohy borst (hemostasis) valve was in a closed position when received and was closed prior to removing the device from the tray.The stent was still constrained within the outer member/sheath, when removed from the tray.The stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered when flushing the stopcock or stent delivery system (sds).The target lesion vessel diameter was 7mm.The intended lesion located was located at the carotid bifurcation.The lesion was severely calcified.There was moderate vessel tortuosity.90% of stenosis was noted.The device was not used for chronic total occlusion (total occlusion >3 months).The delivery system passed through acute bends.The delivery of the stent delivery system (sds) to the lesion was contralateral.There was difficulty encountered while advancing / tracking the sds towards the lesion.There was no unusual force used at anytime during the procedure.The lesion was pre-dilated prior to the stent implantation.A non-cordis balloon was used, size 4mm*30mm, at 10-12 atmosphere (atms).There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The sent did not deploy.The technique was followed that 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.The stent delivery system was successfully removed.The procedure was completed using another unknown stent.The device will not be returned as the patient tested positive for infectious disease.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: f6, f7 ,h1, h2, h9 and h6.The delivery system of a precise pro 9mm x 40mm rapid exchange (rx) self-expanding stent was difficult to withdraw when the stent was released.The intended procedure was carotid artery stenosis (cas).The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the instructions for use.There was nothing usual noted about the stent delivery system prior to use.A non-cordis 8f sheath introducer was used.A cordis 8f guiding catheter was used.The diameter of the unconstrained stent was 1-2mm larger than the vessel diameter.The device was prepped in the tray.The tuohy borst (hemostasis) valve was in a closed position when received and was closed prior to removing the device from the tray.The stent was still constrained within the outer member/sheath, when removed from the tray.The stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered when flushing the stopcock or stent delivery system (sds).The target lesion vessel diameter was 7mm.The intended lesion located was located at the carotid bifurcation.The lesion was severely calcified.There was moderate vessel tortuosity.90% of stenosis was noted.The device was not used for chronic total occlusion (total occlusion >3 months).The delivery system passed through acute bends.The delivery of the stent delivery system (sds) to the lesion was contralateral.There was difficulty encountered while advancing / tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The lesion was pre-dilated prior to the stent implantation.A non-cordis balloon was used, size 4mm*30mm, at 10-12 atmosphere (atms).There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The sent did not deploy.The technique was followed that 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.The stent delivery system was successfully removed.The procedure was completed using another unknown stent.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17896171 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿stent delivery system (sds)-ses-withdrawal difficulty - from vessel¿ could not be confirmed and the exact root cause could not be determined.Handling and or procedural factors such as vessel characteristics of a severely calcified lesion with moderate vessel tortuosity and 90% stenosis may have led to the reported event.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 information available suggests a design or manufacturing related cause 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 60 avenue; miami lakes FL 33014
• MDR Report Key: 10181981
• MDR Text Key: 198852186
• Report Number: 9616099-2020-03757
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

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: 08/31/2021
• Device Model Number: PC0940XCE
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17896171
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/22/2020
• Initial Date Manufacturer Received: 05/24/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 05/24/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BARD SLREAM 4MM*30MM -BALLOON.; TERUMO 8F SHEATH.
• Patient Age: 78 YR
• Patient Weight: 80