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

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: a 6f sheath introducer.Gtin#: (b)(4).The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.

Event Description

During the use of a precise stent to the internal right carotid artery, it was reported that several attempts were made to deploy the stent however, unable to deploy.The target lesion was treated with another stent and the procedure was completed successfully.There was no patient injury reported.Upon removing the sds, it was noted that the stent was partially deployed.It is unknown if this occurred inside the patient or outside the patient.The product will be returned for analysis.The device was prepped per ifu and there was no anomalies noted during this time.There was nothing unusual noted about the stent delivery system prior to use.A 6f sheath introducer.The stent delivery system did not pass through any acute bends.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.The lesion was described as "normal".

Manufacturer Narrative

The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: a report was received that the stent of a 10 x 40mm precise pro rx us carotid system could not be deployed.The device was removed and the procedure successfully completed with another stent delivery system (sds) with no reported patient injury.The event involved a patient undergoing a percutaneous intervention in a target lesion in the right internal carotid artery.The patient¿s vasculature was accessed with the use of a 6fr catheter sheath introducer.The site reported that the sds had been prepped according to the instructions for use (ifu) and that no anomalies were noted during this time.No difficulty was experienced while tracking the device to the target lesion.The sds did not have to pass through any acute bends and no unusual force was required at any time during the procedure.Several attempts to deploy the stent in the target lesion were unsuccessful.The device was removed and the procedure successfully completed with another sds with no reported patient injury.At some point after the device removal and before shipping the device for analysis, the site noted that the stent had partially deployed.One non-sterile precise pro rx us carotid syst was received coiled inside a plastic bag with the stent partially deployed by 2.0cm and the hemostasis valve open.No other damages were found on the received unit.Functional testing of the deployment process was successfully performed with no anomalies found.Dimensional analysis of the stroke length revealed that it was within specification.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿sds - deployment difficulty-partial deployment¿ event was confirmed based on the results of the visual analysis.The cause of this event could not be conclusively determined during the analysis.According to the product ifu, users are instructed to ensure that the sds outside the patient remains flat and straight.Users are instructed to unlock the hemostasis valve prior to stent deployment.They are to ensure that the sheath introducer or guiding catheter does not move during deployment.The ifu further instructs users to initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However handling factors (handling of the sds prior to shipping it) may have contributed to it.Neither the device history record review nor the product analysis suggests that the reported event was related to the manufacturing process.A risk assessment and investigation has been initiated to address these types of issues.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIM)
• 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: 5605352
• MDR Text Key: 43539278
• Report Number: 9616099-2016-00200
• Device Sequence Number: 1
• Product Code: NIM
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2016

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: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17369479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/20/2016; 05/25/2016
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1