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

Model Number	VIUL14040
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation to date.The investigation of the reported event is currently underway.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 during an attempt to advance the delivery system over the guidewire, the vascular stent allegedly started to deploy.It was further reported that the delivery system allegedly became stuck on the guidewire; therefore, everything had to be removed as one unit.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.No relevant manufacturing process changes were implemented that could have led to the event reported.This is the only complaint reported for this lot number and issue to date.Investigation summary: the catheter sample was not returned for evaluation.Medical records, images or photos were not provided.The alleged failure could not be re produced so, the investigation was closed with inconclusive results.The intended application represents an off label use of the device.Based on the information available and because the sample was not returned, a definite root caused could not be identified.Labeling review: the instructions for use (ifu) sufficiently describe the potential issue.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 (.) take care to avoid unnecessary handling, which may kink or damage the delivery system.', and 'should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit.' furthermore, the ifu demands for sufficient flushing of the delivery system through both luer lock adapters.In regards to guidewire, the ifu states: 'the bard® lifestar¿ biliary stent system is only compatible with a 0.035¿ (0.89 mm) guidewire'.The intended 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; the safety and effectiveness of this device for use in the vascular system have not been established.
Event or Problem Description
It was reported that during an attempt to advance the delivery system over the guidewire, the stent allegedly started to deploy.It was further reported that the delivery system allegedly became stuck on the guidewire; therefore, everything had to be removed as one unit.There was no reported patient injury.

• 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: 6832824
• Report Number: 9681442-2017-00252
• Device Sequence Number: 1460500
• Product Code: FGE
• UDI-Device Identifier: 04049519005195
• UDI-Public: (01)04049519005195
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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: 08/31/2017
• Device Model Number: VIUL14040
• Device Catalogue Number: VIUL14040
• Device Lot Number: ANYH0258
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1