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

Catalog Number	EX090803CD
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that during placement of the biliary stent in a pre-dilated lesion of the right common iliac artery via right femoral artery access with another stent in kissing-stent technique, a wire was coming out of the side of the delivery system handle when the deployment wheel was being moved forward.After pushing the wire back into the handle, the stent could be deployed properly.There was no reported patient injury.
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 case, no sample or image was returned.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.This kind of event may be related to high deployment force.Also a difficult vessel anatomy or challenging placement site may lead to high friction during the attempt to release the stent and subsequent deployment force increase.Reportedly, the tracking path and the target lesion were not tortuous or calcified and the lesion had been pre-dilated.The reported application represents an off-label use of the device which may be another contributing factor to the reported event.On the basis of the information available and as no sample was returned for evaluation, a definite root cause for the reported event could not be determined.The ifu states: "if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit." and "examine the stent and delivery system for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used." the ifu indicates that the lifestent biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Event or Problem Description
It was reported that during placement of the biliary stent in a pre-dilated lesion of the right common iliac artery via right femoral artery access with another stent in kissing-stent technique, a wire was coming out of the side of the delivery system handle when the deployment wheel was being moved forward.After pushing the wire back into the handle, the stent could be deployed properly.There was no reported patient injury.

• Brand Name: LIFESTENT BILIARY STENT SYSTEM
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6131935
• Report Number: 9681442-2016-00307
• Device Sequence Number: 651229
• Product Code: FGE
• UDI-Device Identifier: 04049519000527
• UDI-Public: (01)04049519000527(17)170828(10)ANZH2960
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K053404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2016

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: 08/28/2017
• Device Catalogue Number: EX090803CD
• Device Lot Number: ANZH2960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 12/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 78