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

Catalog Number	EX100801CD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2016
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 the biliary stent could not be deployed in the cephalic arch during the stent placement procedure.The access site was an a/v fistula.The stent delivery system could be retracted without difficulties and another stent of the same brand was used to complete the procedure successfully.No patient injury was reported.
Additional Manufacturer Narrative
The device 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 evaluation of the returned device confirmed the reported deployment failure.A broken force transmitting component indicates the presence of high release force which made a successful stent deployment impossible.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 result in high friction during the attempt to release the stent and subsequent deployment failure.The reported application represents an off-label use of the device which also may contribute to the reported event.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "examine the stent and delivery system device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device 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 ifu indicates that the lifestent biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

• 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: 5427558
• Report Number: 9681442-2016-00043
• Device Sequence Number: 988532
• Product Code: FGE
• UDI-Device Identifier: 04049519000619
• UDI-Public: (01)04049519000619(17)170828(10)ANZH2962
• 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): 01/12/2016

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: EX100801CD
• Device Lot Number: ANZH2962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2016
• Supplement Report FDA Received Date: 04/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 86