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

Model Number	ZBM14100
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	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: review of manufacturing records was not performed, as no additional complaint has been reported for this lot.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the investigation of the returned delivery system it could be confirmed that stent deployment using the trigger was impossible.The force transmitting interface between grip and catheter was found broken which led to detachment and subsequent deployment failure using the trigger.Therefore, the investigation will be closed as confirmed for broken component and subsequent failure of the trigger mechanism.An indication for a manufacturing related issue could not be found.Based on the information available a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding potential damages 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.'.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly failed to deploy.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: E-LUMINEXX 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: 9496587
• Report Number: 9681442-2019-00244
• Device Sequence Number: 13838395
• Product Code: FGE
• UDI-Device Identifier: 04049519010465
• UDI-Public: (01)04049519010465
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 08/24/2021
• Device Model Number: ZBM14100
• Device Catalogue Number: ZBM14100
• Device Lot Number: ANCV3410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1