MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR AND BILIARY STENT SYSTEM

Catalog Number	EX060603CS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case no sample was provided for evaluation.Therefore the reported problem could not be reproduced.Potential factors that could have led or contributed to the reported event have been evaluated.Therefore previous investigations of similar complaints have been reviewed.The event may have been associated with insufficient flushing of the device.Reportedly, the system was flushed prior to use.Furthermore, the use of a damaged or incorrect guide wire may have also led to the reported failure.Based on the information available and as no sample was returned, a definite root cause for the reported event could not be determined.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: "examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used", "flush the inner lumen of the stent system with heparinized normal saline prior to use." and "if resistance is met during stent system introduction, the stent system should be removed and another stent system should be used.".
Event or Problem Description
It was reported that the delivery system was advanced and half way it got stuck.This device was the second one which was used in this patient and both devices failed in the same way.A third device was used to complete the procedure.There was no reported patient injury.This is the same patient as reported in medwatch report # 9681442-2016-00062.

• Brand Name: LIFESTENT VASCULAR AND BILIARY STENT SYSTEM
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5470432
• Report Number: 9681442-2016-00061
• Device Sequence Number: 301747
• Product Code: NIP
• UDI-Device Identifier: 04049519001203
• UDI-Public: (01)04049519001203(17)171008(10)ANZJ1395
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2017
• Device Catalogue Number: EX060603CS
• Device Lot Number: ANZJ1395
• Was Device Available for Evaluation?: No
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 03/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 82