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

Catalog Number	VIUS12080
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2017
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 / reporter was unable to provide any further patient or procedural details to bard.
Event or Problem Description
It was reported that the biliary stent could not be deployed.Another stent of the same brand was used to complete the procedure successfully.There was no reported patient injury.
Additional Manufacturer Narrative
The lot history records have been reviewed with special attention to 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 or image 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.This kind of event may be associated with a difficult vessel anatomy or challenging stent placement site resulting in high friction during the attempt to release the stent.Insufficient flushing of the device may be another contributing factor to the reported event.In this case, neither any information regarding the vessel anatomy nor any procedural details were provided.On the basis of the information available and as no sample was returned for evaluation, a definite root cause for the reported event could not be determined.The ifu states: "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." and "do not hold the delivery systemcatheter during stent deployment." furthermore, the ifu states: "prior to inserting the delivery catheter over the guide wire, the system must be flushed with sterile saline at the two female luer ports until saline drips from the distal tip of the catheter.".
Event or Problem Description
It was reported that the biliary stent could not be deployed.Another stent of the same brand was used to complete the procedure successfully.There was no reported patient injury.
Additional Manufacturer Narrative
The lot history records have been reviewed with special attention to manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.On the basis of the evaluation of the returned device, the reported deployment failure could not be confirmed.The stent was found to be partially released upon sample receipt.During the performed function test, the stent could be deployed completely without issues.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.This kind of event may be associated with a difficult vessel anatomy or challenging stent placement site resulting in high friction during the attempt to release the stent.Insufficient flushing of the device may be another contributing factor to the reported event.In this case, neither any information regarding the vessel anatomy nor any procedural details were provided.In addition, the stent could be completely released during the performed function test.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be determined.The ifu states: "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." and "do not hold the delivery system catheter during stent deployment." furthermore, the ifu states: "prior to inserting the delivery catheter over the guide wire, the system must be flushed with sterile saline at the two female luer ports until saline drips from the distal tip of the catheter." updated 'event description' due receipt of additional information.Updated data due to sample receipt.Updated 'additional event information' due to sample receipt.
Event or Problem Description
It was reported that the biliary stent could not be deployed in the common bile duct.Another stent of the same brand was used to complete the procedure successfully.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: 6387678
• Report Number: 9681442-2017-00093
• Device Sequence Number: 16294586
• Product Code: FGE
• UDI-Device Identifier: 04049519005638
• UDI-Public: (01)04049519005638(17)191014(10)ANAX1523
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 05/03/2017

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: 10/14/2019
• Device Catalogue Number: VIUS12080
• Device Lot Number: ANAX1523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 04/03/2017; 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR