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

Catalog Number	EX100401CD
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment in a right femoral vein graft anastomosis using the right femoral av graft as access, the stent failed to deploy.Another device from the same brand was used to complete the procedure.
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.There is no indication for a manufacturing-related failure.The condition of the returned device confirmed the reported deployment failure.The stent was found to be completely loaded in the system.A force transmitting component of the deployment mechanism was found to be broken causing the impossibility to deploy the stent by using the thumbwheel or fast track deployment lever.The stent could be deployed by using the rapid deployment ring during the performed function test.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.A difficult vessel anatomy or challenging placement site may lead to high friction during the attempt to release the stent and subsequent deployment failure.As reported, the lesion had been pre-dilated.The reported application represents an off-label use of the device which is considered a contributing factor to the reported event.On the basis of the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.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." in addition, the ifu indicates that the lifestent biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.The safety and effectiveness of the device for a treatment as described has not been established.
Event or Problem Description
It was reported that during a stent placement in a pre-dilated right femoral vein graft anastomosis via access through a right femoral a/v graft, the biliary stent could not be deployed.Another device from the same brand was used to complete the procedure successfully.There was no reported patient injury.

• Brand Name: LIFESTENT BILIARY STENT
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5942957
• Report Number: 9681442-2016-00239
• Device Sequence Number: 1387729
• Product Code: FGE
• UDI-Device Identifier: 04049519000572
• UDI-Public: (01)04049519000572(17)170820(10)ANZH1919
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/15/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2017
• Device Catalogue Number: EX100401CD
• Device Lot Number: ANZH1919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2016
• Supplement Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR