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

Catalog Number	VIUS14080
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
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 was unable to provide any further patient details to bard.
Event or Problem Description
It was reported that during a stenting procedure in the right iliac vein, the stent delivery system was advanced into the patient's body over a 0.035" guide wire.Amongst advancement inside the patient, the delivery system could not be advanced any further to the desired location as there was resistance between the guide wire and the inner lumen of the system.The device was removed and another stent of the same brand was used to finish the case.There was 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.There is no indication for a manufacturing-related failure.The evaluation of the returned device confirmed the reported event.A guide wire was found to be stuck in the delivery system and could not be removed during evaluation.The stent was found to be completely released which may be a consequence of additional manipulation of the system after the procedure during the attempt to remove the guide wire.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This kind of event may be associated with insufficient flushing of the delivery system resulting in insufficient lubrication which increases the friction inside the guide wire lumen.The event also may be related to the usage of an inappropriate or damaged guide wire.As reported, the system had been flushed and a 0.035" guide wire was used.Rough handling of the device also may be a contributing factor to the reported event as this may lead to device damage.On the basis of the information available and the evaluation of the sample, a definite root cause for the reported event could not be identified.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." 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 states that the device must be flushed through both luer lock adapters.The reported application represents an off-label use of the device.The ifu states that the bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms.
Event or Problem Description
It was reported that during a stenting procedure in the right iliac vein, the stent delivery system was advanced into the patient's body over a 0.035" guide wire.Amongst advancement inside the patient, the delivery system could not be advanced any further to the desired location as there was resistance between the guide wire and the inner lumen of the system.The device was removed and another stent of the same brand was used to finish the case.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: 6335910
• Report Number: 9681442-2017-00054
• Device Sequence Number: 13658631
• Product Code: FGE
• UDI-Device Identifier: 04049519005706
• UDI-Public: (01)04049519005706(17)190923(10)ANAW3474
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/16/2017

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: 09/23/2019
• Device Catalogue Number: VIUS14080
• Device Lot Number: ANAW3474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR