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

Catalog Number PC0730RXC

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

Post stenting of the internal carotid artery with a precise stent (6.0/18mm), it was reported that the physician attempted to remove the stent delivery system (sds) of the precise.However, difficulty was experienced when removing the sds back outside the patient.Therefore, the physician removed the sds with a filterwire (fiter wire ez, bsj).The procedure was finished successfully and there was no patient injury.The lesion was heavily calcification and not tortuosity.The rate of stenosis was 90%.The product will be returned for analysis.

Manufacturer Narrative

Concomitant devices: filter wire ez, bsj.(b)(4).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

Additional information received indicated that no problems occurred with the angioguard received within the precise stent.There was no difficulty removing the product from the package.No kinks were or other damages were noted prior to inserting the precise into the patient.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon through the guide catheter.The precise stent delivery system was removed intact.Complaint conclusion: complaint conclusion: post stenting of the internal carotid artery with a precise stent it was reported that difficulty was experienced when removing the sds from the patient.The physician was able to remove the sds with a filterwire and the procedure was finished successfully with no patient injury.The lesion was heavily calcified with no tortuosity and a stenosis of 90%.There were no problems reported with the angioguard received within the precise stent.There was no difficulty removing the product from the package, no kinks or other damages were noted prior to inserting the precise into the patient.There was no resistance/friction while inserting the sds through the rotating hemostatic valve or while inserting the sds through the guide catheter.The precise stent delivery system was removed intact.One non-sterile precisepro rx us carotid syste 7x30mm was received coiled inside in plastic bag.Unit was deployed.One unknown angioguard was received inserted in device.No other damages could be observed.The outer diameter (od) of the outer sheath was measured in different distances and found within specification.Review of lot 16111554 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The failure reported ¿sds - withdrawal difficulty-from vessel¿ by the customer was not confirmed since no anomalies were found during dimensional analysis.The cause of the failure could not be conclusively determined.Neither the dhr review nor the analysis suggests that the failure is manufacturing process.Therefore no actions were taken.With the information available and without films of the event it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and procedural factors may have contributed to the reported event.

• 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: 4332650
• MDR Text Key: 15126650
• Report Number: 9616099-2014-00804
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: PC0730RXC
• Device Lot Number: 16111554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Date Device Manufactured: 04/24/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1