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

Catalog Number PC0930XCE

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

During a stenting procedure to the right common carotid artery, it was reported that there was difficulty experienced when withdrawing the precise stent delivery system out of the target vessel, post deployment.The surgeon had to withdraw it with the angioguard together.The product was removed intact (in one piece) from the patient.No adverse event on the patient.The device was prepped per ifu instructions.There were no anomalies noted prior to inserting the device into the patient.There was no difficulty advancing the sds through the vessel.There was no difficulty crossing the lesion.The catheter was not in an acute bend.The sds did not have to go through any previously deployed stent when being withdrawn.The target vessel / lesion characteristics are unknown.The lesion was 90% stenosis.There were no issues with the angioguard.

Manufacturer Narrative

The patient's gender is unknown.Complaint conclusion: during a stenting procedure to the right common carotid artery it was reported that there was difficulty experienced when withdrawing the precise stent delivery system out of the target vessel, post deployment.The surgeon had to withdraw it with the angioguard together.The product was removed intact (in one piece) from the patient.The device was prepped per ifu instructions and there were no anomalies noted prior to inserting the device into the patient.There was no difficulty advancing the sds through the vessel nor was there any difficulty crossing the lesion.The catheter was not in an acute bend and did not go through any previously deployed stent when being withdrawn.The target vessel / lesion characteristics are unknown but it did have a 90% stenosis.There were no reported issues with the angioguard.There was no reported patient injury.One non-sterile precise pro rx ous carotid system, 6f, 9mm x 30mm, 135 cm was received coiled inside in plastic bag.Unit was deployed.Hemostasis valve was received closed.Stent was received.Bents were detected at 15cm and 73cm from id band.No other damages could be observed.The outer diameter (od) of the outer sheath was measured in different distances and found within specification.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 cause of the "bents" condition found could not be conclusively determined; however it does not appear to be manufacturing related.Controls are in placed at the final assembly and packaging processes to detect this kind of issue.The failure reported ¿sds-withdrawal difficulty¿ 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
• Manufacturer (Section D): 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: 4054428
• MDR Text Key: 4906731
• Report Number: 9616099-2014-00559
• 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: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: PC0930XCE
• Device Lot Number: 15859770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR