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

Catalog Number PC0830XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/25/2014

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: when the surgeon opened the package it was noted that the tip of the stent has been deployed.The physician changed to another one in order to complete the procedure.There were no damages or anomalies noted to the packaging or other damages noted to the product.One non-sterile precise pro rx ous carotid system, 5f, 8mm x 30mm, 135 cm was received coiled inside a plastic bag.Unit was partially deployed (1.0cm).Hemostasis valve was received closed.No other discrepancies were found.The usable length was measured and it was found acceptable according specification.Functional test (deployment process) was performed and no anomalies were found.Review of lot 15901497 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.No units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.The failures ¿sds - deployment difficulty-premature/prior to use¿ reported by the customer was confirmed.The cause of the failure could not be conclusively determined; however it does not appear to be manufacturing related since during dimensional and functional analyses no anomalies were found.Controls are in place at the final assembly and packaging process to detect this kind of issue.Neither the dhr review nor the analysis suggests that the failure is manufacturing process.Therefore no actions were taken.With the limited amount of information available it is not possible to draw a clinical conclusion between the device and the event.

Event Description

As reported, the surgeon opened the package and found the tip of the stent has been deployed.The physician changed to another one in order to complete the procedure.No adverse event on the patient as this was noted prior to use.The intended procedure is unknown.There were no damages or anomalies noted to the packaging for the precise pro product.However, the tip of the stent had been deployed when opening the package.There were no other damages noted to the product.The physician changed to another unknown product in order to complete the procedure.No adverse event on the patient.

Manufacturer Narrative

The device has been received, but the engineering report is not yet available.However, it will be provided within 30 days upon receipt.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.(b)(6).It was reported that this event took place in the first affiliated hospital of (b)(6).

• 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: 4341582
• MDR Text Key: 12973393
• Report Number: 9616099-2014-00810
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: PC0830XCE
• Device Lot Number: 15901497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2013
• Type of Device Usage: Initial
• Patient Sequence Number: 1