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

Model Number PC1040RXC

Device Problems Material Frayed (1262); Difficult to Advance (2920); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of two products involved with the reported event.(b)(4).The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During use, it was reported that a precise pro stent did not cover the lesion.Another precise pro stent was used and during advancement through the first stent, the delivery system was caught by the proximal edge of the first stent.The precise pro stent delivery system was removed, and the first was dilated by a balloon catheter (5mm).The complaint stent was inserted again, but it was confirmed that the distal end of the outer sheath was frayed.There was no reported patient injury.Therefore the second precise stent was replaced with a new unknown stent and the procedure was completed successfully.The target lesion was the origin of the left internal carotid artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The stenosed length was over 2 cm.The internal diameter of the vessel was 9 mm.The concomitant guidewire was a non cordis wire and the concomitant guiding catheter was non cordis guide catheter.A precise pro (10mm*4cm) was delivered to the lesion and implanted from the left common carotid artery to the left internal carotid artery.Then the distal lesion was not covered.The product was clinically used.And will not be returned for analysis.

Manufacturer Narrative

During use, it was reported that a precise pro rx stent did not cover the lesion.Another precise pro rx stent was used and during advancement through the first stent, the delivery system was caught by the proximal edge of the first stent.The precise pro stent delivery system was removed, and the first was dilated by a balloon catheter (5mm).The complaint stent was inserted again, but it was confirmed that the distal end of the outer sheath was frayed.There was no reported patient injury.Therefore the second precise stent was replaced with a new unknown stent and the procedure was completed successfully.The target lesion was the origin of the left internal carotid artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The stenosed length was over 2 cm.The internal diameter of the vessel was 9 mm.The concomitant guidewire was a non cordis wire and the concomitant guiding catheter was non cordis guide catheter.A precise pro (10mm*4cm) was delivered to the lesion and implanted from the left common carotid artery to the left internal carotid artery.The distal part of the lesion was not covered.The product was clinically used and will not be returned for analysis.The product was not returned for analysis.A device history record (dhr) review of lot 17488439 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip frayed/split/torn ¿ in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Although the vessel characteristics are unknown, characteristics of tortuosity, calcification and rate of stenosis may have contributed to the reported event.The reported ¿stent-incorrect length too short¿ could not be confirmed as the device was not returned due to placement in patient.The exact cause could not be determined.Also reported was ¿stent delivery system-tracking difficult-through another stent.¿ according to the instructions for use ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.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.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ also according to instructions for use, ¿measure the length of the target lesion to determine the length of stent(s) required.Measure the diameter of the reference vessel (proximal and distal to the lesion).It is necessary to select a stent which has an unconstrained diameter that is at least 1 mm larger than the largest reference vessel diameter to achieve secure placement.Neither the dhr¿s nor the information available suggests a design or manufacturing related cause for the reported burst; therefore, no corrective/preventive action will be taken.

• 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: 7299275
• MDR Text Key: 101172888
• Report Number: 9616099-2018-01948
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: 20705032036556
• 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: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17488439
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/30/2018
• Date Manufacturer Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE WAS A FILTER WIRE EZ (BOSTON SCIENTIFIC)