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

Model Number	VIUS07040
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records review was completed.The device was returned to the manufacturer for evaluation.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 a biliary stent deployment procedure, the stent deployed but allegedly would not expand.Reportedly, another stent was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during a biliary stent deployment procedure, the stent deployed but allegedly would not expand.Reportedly, another stent was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: based on the lot history review the used product complied with all manufacturing specifications leading to final device release.In reviewing manufacturing and quality records, no relevant manufacturing process changes were implemented that could have led to the event reported.No manufacturing anomalies or deviations, which may have caused or contributed to the event reported, have been identified.Investigation summary: based on the investigation of the returned catheter sample a failure to expand could not be confirmed.The system was returned in used state including released and fully expanded stent.The radial stent strength was judged as being regular.A damage or any kind of conspicuity indicating a deployment or expansion issue could not be identified; residuals of blood could not be found even by means of microscope.Images have not been provided.The investigation will be closed with inconclusive result.An indication for a process related issue could not be found.Labeling review: based on the lot number reported the following ifu is supplied with this product: b05686, and b05685.Currently valid: b05686 rev.3/03-16 and b05685 vers.2/12-1.In reviewing the currently valid labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.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.' in regards to damage the ifu states: 'visually inspect the bard lifestar vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment.'.

• 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: 7522920
• Report Number: 9681442-2018-00065
• Device Sequence Number: 1224113
• Product Code: FGE
• UDI-Device Identifier: 04049519005331
• UDI-Public: (01)04049519005331
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: 12/16/2019
• Device Model Number: VIUS07040
• Device Catalogue Number: VIUS07040
• Device Lot Number: ANAZ2279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 118