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

Catalog Number	EX100801CD
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.Not returned.
Event or Problem Description
It was reported that during the stent placement procedure for treatment of a recurring lesion in the cephalic vein, the wheel of the deployment mechanism stopped clicking after two turns and the tip of the vascular stent was shot out.The placement of the stent was continued without issue and the stent could be implanted successfully after the initial malfunction.No other device had to be used and no additional treatment was required.No patient injury was reported.
Additional Manufacturer Narrative
The lot 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 event.The stent was found to be released and missing as it remains implanted.During the performed functional test, the thumbwheel was found to be subject of high force which may have led to the reported difficulties in deploying the stent.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The event may be associated with difficult anatomic conditions leading to increased friction and subsequent deployment difficulties.The reported application in the cephalic vein represents an off-label use of the device which is considered another contributing factor to the reported event.On the basis of the information available, a definite root cause 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." furthermore, the ifu indicates that the life-stent 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: 5545234
• Report Number: 9681442-2016-00095
• Device Sequence Number: 10903276
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2016

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: 04/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2016
• Supplement Report FDA Received Date: 06/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 96