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

Catalog Number	VIUS14040
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that the stent system would not track over the 0.035 '' access wire smoothly and that prior to the stent system entering the patient, the stent allegedly began to deploy.It was further reported that as the hcp was removing the stent system, the inner lining of the device separated from the device and stayed on the wire.Another stent was used to perform the procedure.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.There is no indication for a manufacturing-related failure.The evaluation of the returned device confirmed the reported inner catheter breakage.The inner catheter was found stuck on the returned guide wire.The stent had been released completely.On the basis of the condition of the returned device, the premature stent deployment could not be reproduced.An image showing the partially released stent was also returned.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may be associated with improper transportation or storage of the product.The event also may be related to inappropriate accessories used.Also insufficient flushing of the device may contribute to the reported event as this may cause increased friction in the guide wire lumen.Rough handling of the device may be another contributing factor to the reported event as this can lead to device damage and subsequent inner catheter breakage.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "visually inspect the bard lifestar biliary stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment." and "if the safety clip has been removed or becomes inadvertently detached from the grip, do not use the device." also the ifu states that the delivery system must be flushed prior to use.The reported application represents an off-label use of the device.The bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms.

• Brand Name: LIFESTAR 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: 5339661
• Report Number: 9681442-2016-00001
• Device Sequence Number: 16237885
• Product Code: FGE
• UDI-Device Identifier: 04049519005683
• UDI-Public: (01)04049519005683(17)180710(10)ANZG1272
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Followup
• Report Date (Section B): 12/03/2015

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: 07/10/2018
• Device Catalogue Number: VIUS14040
• Device Lot Number: ANZG1272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/01/2016
• Supplement Report FDA Received Date: 03/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 91