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

Model Number	VIUS14060
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical images were provided to the manufacturer for review.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.
Event or Problem Description
It was reported that after successfully implanting the biliary stent to treat stenosis in a curved right innominate vein via access through a right brachiobasilic fistula and upon removal of the post dilatating pta balloon, the stent allegedly was pulled back with the balloon and collapsed.It was further reported that a stent graft was used to cover the collapsed stent and balloon dilatation was performed to apose the stents to the vessel wall.Another device was used to cover the target lesion and complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: 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 the specification prior to shipment.The review showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: based on images provided it could be confirmed that a stent was placed and that the position of the released stent changed during patient treatment.The image quality was poor so that a detailed description of the strut structure was not possible but the distal and proximal markers of the stent appeared clustered after dislocation.In combination with the event description it was concluded that the stent was entrapped during balloon catheter withdrawal.Based on the information available, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the current labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential factor of an irregular stent placement.The ifu states: "remove all slack from the catheter delivery system to avoid stent misplacement (.) do not hold the delivery system catheter during stent deployment (.) as with all self-expanding nitinol stents, careful attention during stent deployment is warranted to mitigate the potential for movement of the stent (.) to maximize stent placement accuracy, slowly and deliberately deploy the distal portion of the stent until you have visual confirmation of wall apposition before steadily deploying the remaining length of the stent.".Furthermore, 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.".In regards to pta the ifu states: "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician.", and "post-dilatation of the stent with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician." the bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms.In this case the delivery system was used for treatment of a stenosis in the brachiocephalic vein.H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that after successfully implanting the biliary stent to treat stenosis in a curved right innominate vein via access through a right brachiobasilic fistula and upon removal of the post dilatating pta balloon, the stent allegedly was pulled back with the balloon and collapsed 15cm from the target lesion.It was further reported that a stent graft was used to cover the collapsed stent and balloon dilatation was performed to apose the stents to the vessel wall.Another device was used to cover the target lesion and complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTARBILIARY STENT SYSTEM
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8351315
• Report Number: 9681442-2019-00022
• Device Sequence Number: 18883720
• Product Code: FGE
• UDI-Device Identifier: 04049519005690
• UDI-Public: (01)04049519005690
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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 Model Number: VIUS14060
• Device Catalogue Number: VIUS14060
• Device Lot Number: ANCU3823
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 78