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

Model Number PC1030RXC

Device Problem Partial Blockage (1065)

Patient Problem Stroke/CVA (1770)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

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

It was reported that the precise pro rx stent would not load on the wire as there seemed to be something inhibiting the distal wire port of the stent.The device was discarded and never entered the patient in a rush because the angioguard filter was ready for use.A new precise stent was loaded on the wire with no difficulty.After the precise stent was implanted, the filter was extracted from the patient and it was noticed that the filter basket seemed torn alone one side.This most likely happened during the retrieval of the filter.The physician said that the angioguard filter did not feel caught on the stent.However, the physician examined under xray during retrieval and the filter stopped within the stent.Then all of the sudden jerked out quickly.The physician was unable to tell if the filter was caught, then came free or if he just yanked it out quickly.The patient experience slurred speech and left facial droop during the middle of the procedure.A neurologist specialist was called in, a clot was located in a small branch of the brain.The neurologist specialist concluded that the vessel was too small to retrieve the emboli.The neurologist later followed up with the physician to let them know that the patent had experienced a quick recovery in a couple of days.A picture of the angioguard filter is available but the devices are not available for analysis.

Manufacturer Narrative

This is one of two products involved with the reported event.The manufacturing reference number for this event is (b)(4).The manufacturing reference number for the other complaint is (b)(4).

Manufacturer Narrative

During a carotid artery stenting case, after an angioguard filter was placed, it was reported that the precise pro rx stent would not load on the wire.There seemed to be something inhibiting the distal wire port of the stent.The device was discarded.A new precise stent was loaded on the wire with no difficulty.After the precise stent was implanted, the filter was extracted from the patient and it was noticed that the filter basket seemed torn alone one side.Per the voice of the customer ¿this most likely happened during the retrieval of the filter¿.The physician said that the angioguard filter did not feel to be caught on the stent.The physician stated angiographic imaging performed during retrieval showed that the filter had stopped within the stent and then all of the sudden jerked out quickly.The physician was unable to tell if the filter was caught, then came free or if he just yanked it out quickly.The patient experience slurred speech and left facial droop during the middle of the procedure.A neurologist specialist was called in, a clot was located in a small branch of the brain.The neurologist concluded that the vessel was too small to retrieve the emboli.The neurologist later followed up with the physician to let them know that the patent had experienced a quick recovery in a couple of days.The target lesion was the carotid artery which was not calcified or tortuous.The lesion is at a bifurcation.The access site was femoral.The device was prepped according to the instruction for use (ifu).There was no difficulty experienced in prepping the devices.The device was never in an acute bend.The product was not returned for analysis.A device history record (dhr) review of lot 17540008 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported failure by the customer of ¿luer-hub obstructed during use¿ in regards to the precise pro was unable to be confirmed as the device was not returned for analysis.The event reported by the customer as ¿filter basket- withdrawal difficulty - snagged/caught¿ was not confirmed.It is unknown what factors may have contributed to this issue.Handling or procedural factors may have contributed to the event.Vessel characteristics, tortuosity and level of calcification may have also contributed to the event.The function of an embolic protection device is to capture debris during the carotid procedure and prevent it from embolizing downstream into the patient¿s vasculature.The product¿s information for safety warns ¿the deployment and capture sheaths are delicate instruments and should be handled carefully.Prior to use, and when possible during the procedure, inspect the deployment sheath, capture sheath, and capture sheath rx port region (approximately 30 cm from the distal tip) for bends, kinks, or other damage.¿ the picture review does not suggest that the reported failures could be related to the manufacturing process of the unit.Neither the dhr review nor the product analysis suggests that the malfunction experienced by the customer could be related to the manufacturing process; 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 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7048754
• MDR Text Key: 92631738
• Report Number: 9616099-2017-01600
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036549
• UDI-Public: 20705032036549
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: PC1030RXC
• Device Catalogue Number: PC1030RXC
• Device Lot Number: 17540008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/24/2017
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2016
• 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