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

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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.

Event Description

A precise stent delivery system (sds) was delivered to an unknown lesion and when the physician tried to deploy the stent, it was confirmed that the stent was not deployed although the system was withdrawn completely.After the procedure, the precise was separated when it was checked by the physician.Another new precise of different size was use to complete the procedure successfully.There was no reported patient injury.The product will be returned for analysis.The product was stored and handled according to the ifu.The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The sds was delivered to the lesion with a 6f guiding catheter.The following information is unknown: the intended procedure, the brand of the guiding catheter used, the vessel /lesion characteristics, if the stent delivery system passed through any acute bends, if the delivery of the sds to the lesion was ipsilateral or contralateral, if there was any difficulty encountered while advancing/tracking the sds towards the lesion, if there was any unusual force used at any time during the procedure, if there was any difficulty or resistance noted while crossing the lesion with the stent, if the sds have to pass through a previously placed stent, if the user maintained a fixed inner shaft position during deployment, if there was any unusual force applied during deployment of the stent or if the stent pre-maturely deployed.

Manufacturer Narrative

Based on additional information obtained from the customer, it was confirmed that the separated area of the product involved was the outer sheath member near the wire port which does not meet mdr regulatory criteria.Please update your file as appropriate.

• 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: 5643066
• MDR Text Key: 44894734
• Report Number: 9616099-2016-00229
• 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: 04/15/2016

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: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 17280877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2016
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1