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

Catalog Number	EX080801CD
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2016
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 stenting of a pre-dilated lesion in the axillary vein via access through the loop of a graft, the biliary stent could not be deployed by rotating the thumbweel of the deployment mechanism.Reportedly, there was no partial release of the stent and the delivery system could be retracted without issues.Another stent of the same brand was used to complete the procedure successfully.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.Based on the sample evaluation the reported failure to deploy could not be confirmed.During sample evaluation the stent could be completely deployed without problem by starting the deployment process with the thumbwheel and complete the release process by using the fast track deployment lever.No deficiency was found on the delivery system which may have led to the reported event.Previous investigations of similar complaints have been reviewed.A difficult patient anatomy or a challenging placement site may result into high friction during the attempt to release the stent and subsequent deployment failure.However, the reported application of the stent placement in the auxiliary vein represents an off label use of the device, which may have been a contributing factor.A manufacturing related root cause was also considered and during sample evaluation no device deficiency was found which may have led to the reported event.On the basis of the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be identified.The ifu states: "examine the stent system for any damage.If it is suspected that the sterility or performance of the device has been compromised, the stent system should not be used." and "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." furthermore, the reported application represents an off label use of the device.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 stenting of a pre-dilated lesion in the axilliary vein via access through the loop of a graft, the biliary stent could not be deployed by rotating the thumbweel of the deployment mechanism.Reportedly, there was no partial release of the stent and the delivery system could be retracted without issues.Another stent of the same brand was used to complete the procedure successfully.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: 6094084
• Report Number: 9681442-2016-00288
• Device Sequence Number: 958950
• Product Code: FGE
• UDI-Device Identifier: 04049519000411
• UDI-Public: (01)04049519000411(17)180525(10)ANAS2785
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K053404
• 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): 10/19/2016

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: 05/25/2018
• Device Catalogue Number: EX080801CD
• Device Lot Number: ANAS2785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 12/20/2016
• 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: 73