MAUDE Adverse Event Report: CORDIS US. CORP PRECISE PRO RX OUS; STENT, CAROTID

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, the stent of a precise pro rx 8 mm x 40 mm self-expanding stent delivery system (ses) did not deploy.The sds was not removed from the patient with the stent still in place.When removed, the stent was released less than a segment but did not dislodge.The stent was then withdrawn into the delivery system.The device was being used for a carotid artery stenting (cas) procedure.The device was stored, prepped, and opened as per the instructions for use (ifu).There were no damages to the packaging or device prior to use in the patient.The device was not attempted to be deployed outside of the body.There was no difficulty removing the product from the packaging.The target vessel was calcified with mild tortuosity.There was no acute angle, no bifurcation, no cto, and 60% stenosis.The stent delivery system did not pass through any acute bends.A contralateral approach was used.The sds did not have to pass through a previously placed stent.The user maintain a fixed inner shaft position during deployment.There was no unusual force applied during deployment of the stent.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 18125520revealed 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- partial deployment, was not confirmed since the unit was not returned for analysis.According to the instructions for use (ifu) ¿advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.If resistance is felt during retraction of the outer sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ neither the phr review nor the information available suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, the stent of a precise pro rx 8 mm x 40 mm self-expanding stent delivery system (ses) did not deploy.The sds was not removed from the patient with the stent still in place.When removed, the stent was released less than a segment but did not dislodge.The stent was then withdrawn into the delivery system.There was no reported patient injury.The device was being used for a carotid artery stenting (cas) procedure.The device was stored, prepped, and opened as per the instructions for use (ifu).There were no damages to the packaging or device prior to use in the patient.The device was not attempted to be deployed outside of the body.There was no difficulty removing the product from the packaging.The target vessel was calcified with mild tortuosity.There was no acute angle, no bifurcation, no cto, and 60% stenosis.The stent delivery system did not pass through any acute bends.A contralateral approach was used.The sds did not have to pass through a previously placed stent.The user maintain a fixed inner shaft position during deployment.There was no unusual force applied during deployment of the stent.The device was not returned for evaluation as was initially expected.

• Brand Name: PRECISE PRO RX OUS
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 17378491
• MDR Text Key: 319974222
• Report Number: 9616099-2023-06556
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062425
• UDI-Public: (01)20705032062425(17)240630(10)18125520
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 18125520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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: CORDIS VASCULAR SHEATH
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 72 KG