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

Model Number PC0940RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, a 9x40 precise pro rapid exchange (rx) carotid stent could not be deployed.Therefore, it was replaced with a new 10/40mm precise pro and the new device could be deployed and implanted.Additional information was received and during fal, the stent was partially deployed.There was no reported patient injury.This was a carotid artery stenting (cas) case.The lesion was the right carotid artery which has stenosis.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The lesion included the common carotid artery to internal carotid artery.An approach was made from the inguinal region with a non-cordis 8f guiding sheath and advanced to the common carotid artery.The intended lesion was calcified.The lesion has moderate calcification but there is no vessel tortuosity.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.After filtering the internal carotid artery distal area with a non-cordis embolic protection system, pre-pta was performed with a non-cordis 2.5mm x 4cm balloon catheter at the stenosis part.The device was primed as usual and it could cross the lesion and then the doctor loosened the y-connector, but the outer cylinder could not be pulled at all.The doctor confirmed the looseness of the y-connector again and tried to deploy it.After the procedure, the doctor washed the complaint precise pro and tried to deploy it.However, it still could not be deployed.The device is expected to be returned for evaluation.Other additional procedural details were requested but are unknown.

Manufacturer Narrative

A precise pro 9mm x 40mm rapid exchange (rx) carotid stent could not be deployed.Therefore, it was replaced with a new precise pro 10mm x 40mm and the new device could be deployed and implanted.Additional information was received and during fal, the stent was partially deployed.This was a carotid artery stenting (cas) case.The lesion was the right carotid artery which had stenosis.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The lesion included the common carotid artery to internal carotid artery.An approach was made from the inguinal region with a non-cordis 8f guiding sheath and advanced to the common carotid artery.The intended lesion was calcified.The lesion has moderate calcification but there was no vessel tortuosity.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.After filtering the internal carotid artery distal area with a non-cordis embolic protection system, pre-pta was performed with a non-cordis 2.5mm x 4cm balloon catheter at the stenosis part.The device was primed as usual, crossed the lesion and then the doctor loosened the y-connector, but the outer cylinder could not be pulled at all.The doctor confirmed the looseness of the y-connector again and tried to deploy it.After the procedure, the doctor washed the complaint precise pro and tried to deploy it.However, it still could not be deployed.There was no reported patient injury.The product was returned for analysis.One non-sterile precise pro rx us carotid system stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received partially locked/ locked.Per visual analysis, the stent of the unit was received 2mm partially deployed.An accordion damaged was noted on the body shaft of unit at the id band area.Also, kinked and bent damages could be observed on the unit.Kinks were found at 11.0 cm and at 11.5 cm from the id band (proximal area) and other kink was found at 5.5 cm from the brite tip of unit (distal area).No other anomalies were observed.Per functional test, deployment test was successfully performed despite the damage condition of the unit.The valve of the stent delivery system was unlocked / opened.The stent was completely deployed.Neither difficulty nor anomaly (resistance, friction, or incomplete stent deployment) was experienced during the deployment procedure.Per dimensional analysis, usable length of the unit was measured and found within specification.No damages were observed on the stent.A product history record (phr) review of lot 17888936 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 - partial deployment¿ was confirmed due to the partially deployed 2mm stent condition.However, the cause of the partially deployed stent condition, as well as the accordion and kinked /bent damage condition on the body shaft of the unit could not be conclusively determined during the analysis.Per the observed damage condition of the unit, it could be suggested that procedural factors and/ or handling process may have contributed to the accordion and kinked /bent damage condition on the body shaft of the unit, as well as to the observed partially deployed condition of the stent.According to the precautions in the safety information of the instructions for use, ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to the stent or lumen.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.Prior to stent deployment, remove all slack from the catheter delivery system¿.Neither the product analysis nor the phr review suggests that the event experienced by the customer is related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9872044
• MDR Text Key: 200252760
• Report Number: 9616099-2020-03592
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036525
• UDI-Public: 20705032036525
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: PC0940RXC
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 17888936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1