MAUDE Adverse Event Report: COOK INC ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

Model Number N/A

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

Common name: catheter, biliary, diagnostic.Product code: fge.(b)(4).Pma/510(k) #: k080037 investigation - evaluation: a review of the complaint history, dimensional verification, device history record, manufacturing instructions, trends, functional testing, and visual inspection of the returned device was conducted during the investigation.The zilver flex 35 biliary self-expanding stent was returned for evaluation without the original packaging.Upon evaluation, the device was able to be flushed without issue.There was evidence of compression of the flexor and the distal white tip was damaged, indicating severe resistance when advancing over the wire guide.The device was able to be wired with a 0.035¿ diameter wire guide with no issues noted.Buckling was observed on the outer sheath between 6cm and 12cm from the distal white tip.The distal end of the outer sheath was damaged.Review of device history record shows no discrepancies that could contribute to this complaint.There were no other reported complaints for this lot number.Based on the information provided and results of the investigation, a definitive root cause could not be determined.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

Event Description

It was reported that the zilver flex 35 biliary self-expanding stent got stuck and pulled out on the wire.The customer reported that it looked fine out of the packaging.The device did not make patient contact.The procedure was completed successfully with another stent.This problem did not create the need for any intervention or additional procedures.There were no adverse effects to the patient.

• Brand Name: ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6740944
• MDR Text Key: 81071207
• Report Number: 1820334-2017-02065
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002501703
• UDI-Public: (01)10827002501703(17)190222(10)6791277
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: ZIB6-35-125-7-140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1