MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX BILIARY STENT

Catalog Number	ZBM12040
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that the white end piece of the delivery system allegedly broke before the stent was deployed in the left brachiocephalic vein via access through the left arm.Reportedly, the vessel had been pre-dilated and the user had difficulties in advancing the delivery system to the lesion site.The delivery system was removed without issue and another device 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 the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.The evaluation of the returned delivery system confirmed the detachment of the white conversion tab.The conversion tab was missing upon sample receipt and therefore, the reported breakage could not be confirmed.The proximal end of the delivery system was found to be detached from the grip which may have led to the reported deployment failure, however, the system was found to have been actively used and the stent was not part of the sample return so that a deployment failure could not be confirmed.The disposition of the stent is unknown.Potential contributing factors to the reported event have been evaluated.As the event was found to be an isolated incident, no previously reported similar complaints could have been reviewed.In this case, it was reported that the white end piece broke prior to stent deployment, and the white conversion tab as well as the proximal end of the delivery system was found to be detached from the grip during sample evaluation.This kind of event may be related to rough handling of the device during shipment, storage or preparation.Furthermore, a deployment failure was reported which is considered a subsequent event of the conversion tab detachment.A difficult vessel anatomy or insufficient flushing of the device also may be contributing factors to the reported deployment failure.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "visually inspect the bard e-luminexx biliary stent 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." the reported stent placement in the brachiocephalic vein represents an off-label use of the device.The ifu states that the device is indicated for the treatment of biliary strictures resulting from malignant neoplasms.Updated data due to sample receipt.Updated 'eval code & desc - conclusion1' due to completion of evaluation.
Event or Problem Description
It was reported that the white end piece of the delivery system allegedly broke before the stent was deployed in the left brachiocephalic vein via access through the left arm.Reportedly, the vessel had been pre-dilated and the user had difficulties in advancing the delivery system to the lesion site.The delivery system was removed without issue and another device was used to complete the procedure successfully.There was no reported patient injury.

• Brand Name: E-LUMINEXX BILIARY STENT
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6307042
• Report Number: 9681442-2017-00046
• Device Sequence Number: 1133636
• Product Code: FGE
• UDI-Device Identifier: 04049519010366
• UDI-Public: (01)04049519010366(17)190729(10)ANAU3829
• 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): 03/27/2017

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: 07/29/2019
• Device Catalogue Number: ZBM12040
• Device Lot Number: ANAU3829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 104