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

Catalog Number PC0840XCE

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17941878 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 8 x 40 precise pro rapid exchange (rx) self-expanding stent (ses) delivery system could not be released properly in patient ¿s body.While releasing, it needed to be pushed harder than usual.The tip didn't fall off, when physician failed stent deployment.They tried to retrieve the whole delivery system back into the unknown guiding catheter, however, the far end of delivery system cannot go back into the guiding due to the partially expanded stent.A non-cordis stent was used to complete the procedure.There was no reported patient injury.The operator was trained to the precise pro device.The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the device prior to use.The device was prepped in the tray.The tuohy borst valve was in the open position when received.The tuohy borst valve was closed prior to removing the device from the tray.When the device was removed from the tray the stent was still constrained within the outer member/sheath.The stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock.There was no difficulty encountered flushing the sds.The lesion was moderately calcified.There was no vessel tortuosity and the device was not used for a chronic total occlusion.There was no difficulty tracking the precise pro through the vessel or lesion.The device did not kink while being used.The user maintained a fixed inner shaft position during deployment.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d8, g3, g6, h1, h2, h3 and h6.As reported, the 8 x 40 precise pro rapid exchange (rx) self-expanding stent (ses) delivery system could not be released properly in the patient ¿s body.While releasing, it needed to be pushed harder than usual.The tip didn¿t fall off, when physician failed stent deployment.They tried to retrieve the whole delivery system back into the unknown guiding catheter, however, the far end of delivery system cannot go back into the guiding due to the partially expanded stent.A non-cordis stent was used to complete the procedure.The operator was trained to the precise pro device.The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the device prior to use.The device was prepped in the tray.The tuohy borst valve was in the open position when received.The tuohy borst valve was closed prior to removing the device from the tray.When the device was removed from the tray the stent was still constrained within the outer member/sheath.The stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock.There was no difficulty encountered flushing the sds.The lesion was moderately calcified.There was no vessel tortuosity, and the device was not used for a chronic total occlusion.There was no difficulty tracking the precise pro through the vessel or lesion.The device did not kink while being used.The user maintained a fixed inner shaft position during deployment.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17941878 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 the reported ¿stent delivery system (sds)-ses~ deployment difficulty - partial deployment¿ and ¿stent delivery system (sds)-ses~ withdrawal difficulty - through guide/sheath¿ were not confirmed.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable to consider that the user¿s interaction with the device during advancement as well as a moderately calcified lesion may have contributed to the reported events.According to the instructions for use (ifu) ¿preparation of stent delivery system: caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.¿ additionally, the instructions for use (ifu) states ¿note: 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 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 8X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12463248
• MDR Text Key: 272289041
• Report Number: 9616099-2021-04864
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062425
• UDI-Public: (01)20705032062425(17)220331(10)17941878
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17941878
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GUIDING CATHETER; WALLSTENT STENT
• Patient Age: 74 YR
• Patient Weight: 70