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

Catalog Number PC0930XCE

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

The report received from the affiliate indicated that a 9x30mm precise stent could not deploy at the target lesion.The device withdrawn with no difficulty and changed to another device to complete the procedure.Analysis of the returned device indicated the body was separated at 8cm from brite tip.No adverse event on the patient.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The target lesion was the an 80% occluded lesion in the internal carotid artery of 8mm in length in a 5mm vessel diameter with no vessel tortuosity.The lesion was also mildly calcified.The intended was not lesion located at the carotid bifurcation.An 8f sheath with an 8f sized guiding catheter were used in the procedure.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The stent delivery system passed through any acute bends.Delivery of the sds to the lesion was contralateral.It was difficult to advance through the lesion.The user maintained a fixed inner shaft position during deployment.

Manufacturer Narrative

It was noted that a 9x30mm precise stent would not deploy at the target lesion.The device withdrawn without difficulty and another device was used to complete the procedure.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The target lesion was an 80% occluded, mildly calcified lesion in the internal carotid artery 8mm in length and 5mm in diameter with no tortuousity.The diameter of the unconstrained stent used was 1-2 mm larger than the vessel diameter.Delivery of the sds to the lesion was contralateral, the sds did pass through acute bends while tracking towards the lesion and difficulty was encountered while advancing through the lesion.The user maintained a fixed inner shaft position during deployment.There was no reported patient injury.Although not reported by the user analysis of the returned device indicated the body was separated at 8cm from brite tip one non-sterile precise pro rx ous carotid system, 6f, 9mm x 30mm, 135 cm was received coiled inside a plastic bag.Unit was not deployed.Valve was received closed.Body was separated at 8cm from brite tip.No other discrepancies were found.Although the unit was received separated the mechanism of the unit was reviewed and the stent could be deployed.The unit was sent to sem analysis in order to analyze the potential cause of body separation; the results showed that the sample presented evidence of elongations.This means that the body was pulled / stretched until separation.During the analysis no evidence of abrasion or scratches were found also tool marks were not found during analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The failure "sds - deployment difficulty-unable" reported by the customer was confirmed; the cause of the failure could be related to the body separation condition; in addition the mechanism of the unit was reviewed and the stent could be deployed.The exact cause of the separation does not appeared to be manufacturing related since during microscopic analysis there is evidence of elongations.Procedural factors could be related to the failure.Controls are in place to detect body separation.Therefore no corrective or preventive actions will be taken.The failure "sds - deployment difficulty-unable" reported by the customer was confirmed.Although not reported by the user the cause of the failure could be related to the separation of the outer shaft.As the returned device presented evidence of elongations it appears that the body was pulled / stretched until it separated.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
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3873688
• MDR Text Key: 18569338
• Report Number: 9616099-2014-00383
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/25/2014

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: 07/31/2015
• Device Catalogue Number: PC0930XCE
• Device Lot Number: 15945754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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