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

Catalog Number PC0620RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

It was reported that the precise pro rx stent was deployed prematurely.The product was not used in the patient, and there was no report of patient injury.The procedure was completed successfully with another stent.The device was stored and handled and prepped according to the ifu.There weren¿t any other anomalies or damages noted to the device or packaging.The product will be returned for analysis.

Manufacturer Narrative

(b)(4).The product has not yet been returned for analysis, therefore the engineering evaluation has not yet been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

The product was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: it was reported that the precise pro rx stent was deployed prematurely.The product was not used in the patient, and there was no report of patient injury.The procedure was completed successfully with another stent.The device was stored and handled and prepped according to the ifu (instructions for use).There weren¿t any other anomalies or damages noted to the device or packaging.The product was not returned for analysis.A device history record (dhr) review of lot 17104860 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• 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: 4947414
• MDR Text Key: 6193019
• Report Number: 9616099-2015-00325
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: PC0620RXC
• Device Lot Number: 17104860
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1