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

Catalog Number	VIUS10120
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2016
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 was unable to provide any patient details.
Event or Problem Description
It was reported that the biliary stent which was intended to be placed at the apex of a forearm graft, did not deploy simultaneously resulting in the stent to be elongated.The delivery system and stent graft were removed from the patient with no issues.No patient injury was reported.This is the same patient as reported in medwatch report # 9681442-2016-00073.
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 stent confirmed the reported stent elongation.The stent length (length between the radiopaque marker sections) was measured to 127 mm.Furthermore, deformations of the stent strut structure were found.As the delivery system was not provided for evaluation, the alleged correlation of the stent elongation and the delivery system could not be verified.Potential contributing factors to the reported event have been considered.As the reported event was found to be an isolated incident, no previous investigations of similar complaints could have been reviewed.A challenging stent placement site as well as tortuous or calcified vessels may contribute to an irregular stent placement.The reported application represents an off-label use of the device which is considered another contributing factor to the reported event.The event also may be associated with an unintended movement of the delivery system during deployment.Excessive compression of the outer catheter during deployment or incorrect holding may cause a change of the stent length.On the basis of the information available, a definitive root cause for the reported event could not be determined.The ifu supplied with this product sufficiently describes the correct application of the device.Furthermore, the ifu states: "should unusual resistance be felt at any time during the procedure, the entire system should be removed as a single unit." and "once the stent is partially or fully deployed, micro-adjustments are no longer possible and the stent should not be dragged or repositioned in the lumen." the ifu indicates that the lifestar biliary stent system is intended 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: 5492926
• Report Number: 9681442-2016-00074
• Device Sequence Number: 446068
• Product Code: FGE
• UDI-Device Identifier: 04049519005584
• UDI-Public: (01)04049519005584(17)180904(10)ANZI0776
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2016

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: 09/04/2018
• Device Catalogue Number: VIUS10120
• Device Lot Number: ANZI0776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2016
• Supplement Report FDA Received Date: 05/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1