MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS

Catalog Number PC0940XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2016

Event Type  malfunction  

Manufacturer Narrative

Please note that the gender of the patient is unknown.(b)(6).The device is expected to be returned for analysis; however, it has not yet been received.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the physician reported that stent has not been opened during the procedure.To procedure completed physician used another one product the same type.No consequences for the patient reported.

Manufacturer Narrative

A 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.

Manufacturer Narrative

Additional information was recently obtained that the stent could not be deployed in the patient and was removed with no deployment.This device failure is unlikely to cause an injury if it were to reoccur; therefore, this complaint no longer meets the required criteria for medical device reporting.This file was inadvertently submitted as a complaint under the medical device reporting regulations.No further reports are forthcoming.Additional information was received: the stent was unable to be deployed when the user tried to deploy the stent.The intended procedure was stenting for stenosis of the internal carotid artery.The lesion a stenosis rate of 80-85% and had low degree calcification with no tortuosity.There were no damages or anomalies noted to the device prior to removal from packaging; and there were no damages or anomalies noted to the packaging prior to opening.There was no difficulty experienced as the device was removed from the packaging.The product was stored, inspected, handled, and prepped according to the ifu.The tuohy borst (hemostasis) valve was in the open position when received but was not closed prior to removal from the tray.However, when it was removed from the tray, the stent was still constrained within the outer member/sheath.The stent delivery system did not pass through any acute bends or previously placed stents.The access site was reportedly located in the internal carotid artery.There was no difficulty encountered while advancing/tracking the sds towards/across the lesion and no excessive torquing was used.All the slack was removed from the stent delivery system prior to attempting to deploy and the tuohy borst valve was opened.There was no difficulty removing the stent delivery system from the patient and there was no unusual force used during the procedure.Another precise stent was used to complete the procedure.Analysis of returned product: one non-sterile unit of precise pro rx ous carotid system, 6fr, 9mm x 40mm, 135 cm was received coiled inside a plastic bag with an un-deployed stent and an open hemostasis valve.The precise outer body was found separated at 22.0cm from the brite tip.No other damages were found on the received unit.Functional analysis of the deployment process, while holding the outer member was performed and was successful.Dimensional analysis of the stroke length could not be performed due to the condition of the returned unit.Dimensional analysis of the catheter body inner and outer body revealed that it was within specification.Sem analysis of the separated outer member revealed evidence of material transfer from the distal section of the outer member in some areas; while other areas revealed little evidence of this transfer.This evidence of material transfer may suggest that the distal section of the catheter had been fused to the catheter body at some point.No other issues were noted during the sem analysis.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.Based on additional information provided, this device failure is unlikely to cause an injury if it were to reoccur; therefore, this complaint no longer meets the required criteria for medical device reporting.This file was inadvertently submitted as a complaint under the medical device reporting regulations.No further reports are forthcoming.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5553142
• MDR Text Key: 42034536
• Report Number: 9616099-2016-00172
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2016

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: 05/31/2017
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17274484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/28/2016; 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1