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

Catalog Number	VIUS12120
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.There was no patient involvement.
Event or Problem Description
It was reported that during preparation of the delivery system, the biliary stent was found to be partially deployed.Reportedly, the safety clip was removed by the customer.Another stent was used to perform the procedure.There was no patient involvement and 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.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample was provided for evaluation.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.As reported, the safety clip was removed when the partial stent deployment occurred; the system was not loaded on the guide wire.As the subject device was not returned for evaluation, no further investigation could be performed and the reported event could not be reproduced or confirmed.The correct position of the stent within the sheath as well as the proper assembly of the safety clip is being checked during assembly of the delivery system prior to packaging.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "as a precaution against accidental stent deployment, the safety clip should not be removed until the stent is ready to be deployed.If the safety clip has been removed or becomes inadvertently detached from the grip, do not use the device." the ifu also 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." adverse event and/or product problem; type of reportable event: corrected data.The reported event is not mdr reportable and was reported to the fda by error.There is no reportable device malfunction.Updated 'eval code & desc - (b)(4) due to completion of evaluation.
Event or Problem Description
It was reported that during preparation of the delivery system, the biliary stent was found to be partially deployed.Reportedly, the safety clip was removed by the customer.Another stent was used to perform the procedure.There was no patient involvement and no reported patient injury.

• Brand Name: LIFESTAR BILIARY STENT SYSTEM
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6059803
• Report Number: 9681442-2016-00284
• Device Sequence Number: 13651507
• Product Code: FGE
• UDI-Device Identifier: 04049519005652
• UDI-Public: (01)04049519005652(17)190304(10)ANAQ0861
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/05/2016

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: 03/04/2019
• Device Catalogue Number: VIUS12120
• Device Lot Number: ANAQ0861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1