MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Model Number PC1040RXC

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18031803 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the stent of a precise pro rx 10mmx40mm nitinol stent system could not be deployed.The physician tried to loosen the valve and deploy the stent, but it was too hard to pull the outer sheath and could not be deployed.Therefore, it was replaced with a new 10mmx3mm precise pro and the procedure was completed.There was no reported patient injury.There was no damage to the outer sheath noticed when removed from the patient.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, inspected, prepped, and handled according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The procedure was a carotid artery stenting (cas) of the right carotid artery that had stenosis.The lesion was from the internal carotid artery (ica) to the common carotid artery (cca).The vessel had moderate tortuosity.The target lesion vessel diameter was 5-9mm.Access was obtained via left inguinal region with a 6f non cordis sheath.A 6f unknown guide catheter was used.A "filter wire" was placed at the distal portion of the internal carotid artery (ica).The lesion was pre-dilated with an unknown balloon catheter and the precise pro sds was delivered to the lesion.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did have to pass through a previously placed stent.After the device was removed from the patient, deployment was attempted but it was extremely hard and required considerable force.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for evaluation.Addendum: a thorough inspection was performed during product analysis and the unit presents a partial stent deployment condition.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: the stent of a precise pro rx 10mmx40mm nitinol stent system could not be deployed.The physician tried to loosen the valve and deploy the stent, but it was too hard to pull the outer sheath and could not be deployed.Therefore, it was replaced with a new 10mmx3mm precise pro and the procedure was completed.There was no damage to the outer sheath noticed when removed from the patient.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, inspected, prepped, and handled according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.The procedure was a carotid artery stenting (cas) of the right carotid artery that had stenosis.The lesion was from the internal carotid artery (ica) to the common carotid artery (cca).The vessel had moderate tortuosity.The target lesion vessel diameter was 5-9mm.Access was obtained via left inguinal region with a 6f non cordis sheath.A 6f unknown guide catheter was used.A "filter wire" was placed at the distal portion of the internal carotid artery (ica).The lesion was pre-dilated with an unknown balloon catheter and the precise pro sds was delivered to the lesion.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did have to pass through a previously placed stent.After the device was removed from the patient, deployment was attempted but it was extremely hard and required considerable force.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for evaluation.Addendum: a thorough inspection was performed during product analysis and the unit presents a partial stent deployment condition.There was no reported patient injury.The device was returned for analysis.A non-sterile unit of ¿precise pro rx us carotid syst¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed at one metallic tray to be inspected.A thorough inspection was performed observing that the unit presents a partial stent deployment condition.The hemostasis valve was returned closed tight.Functional analysis was performed to determine if the stent can be deployed as expected.Before the deployment process the unit was flushed and no anomalies were observed.The hemostasis valve of the stent delivery system was unlocked.The stent deployment functionally test was initiate by retracting the outer sheath while holding the inner shaft in a fixed position.The push rod traveled toward the distal end deploying completely the stent as expected.The stent expanded presenting no anomalies or damages.A product history record (phr) review of lot 18031803 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 (sds)-ses ~ deployment difficulty - unable¿ was not confirmed.The functional analysis was performed successfully, and the stent was deployed as expected.The reported ¿stent delivery system (sds)-ses ~ deployment difficulty - partial deployment¿ was confirmed, the returned device presents a partial deployment condition.However, the functional analysis was performed successfully, and the stent was deployed as expected.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.¿ vessel characteristics and or user interaction with the device may have led to the reported events.It should be noted that during product analysis, the hemostasis valve was returned tightly closed.Indicating that the end user manipulated the device since the stent delivery system is shipped with the tuohy borst valve open.Neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13449681
• MDR Text Key: 285045938
• Report Number: 9616099-2022-05329
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: (01)20705032036556(17)230531(10)18031803
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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: 05/31/2023
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 18031803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• 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
• Treatment: 6F UNKNOWN GUIDE CATHETER; GUIDING SHEATH (6F FUBUKI DILATOR, ASAHI INTECC); PRECISE PRO (10MM*3CM); UNKNOWN "FILTER WIRE"; UNKNOWN BALLOON CATHETER (4MM*3CM),
• Patient Sex: Male