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

Catalog Number	ZBM07060
Medical Device Problem Codes	Positioning Failure (1158); Sticking (1597); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2015
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 or further procedural details.
Event or Problem Description
It was reported that the stent got stuck in the sheath when being partially deployed and could not be deployed any further.Then the delivery system was disassembled in order to deploy the stent manually; however, without success.The stent which was still located inside the sheath partially could be removed without issue.No patient injury was reported.
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 or image was provided for evaluation.Therefore, the reported event could not be reproduced.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported event may be caused by the detachment of a deployment mechanism component caused by rough handling of the device during shipment, storage or preparation.Also a difficult vessel anatomy or insufficient flushing of the device may contribute to the reported event.In this case, no information regarding the vessel anatomy or the procedure was provided.The reported application represents an off-label use of the device and may be another contributing factor to the reported event.On the basis of the information available and as no sample was returned, a definite root cause for the reported event could not be determined.The ifu states: "visually inspect the bard e-luminexx vascular 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 should be removed as a single unit." the stent placement in the venous system represents an off-label use of the device; the ifu states that the device is intended for use in the treatment of iliac occlusive diseases or for the treatment of biliary strictures.

• Brand Name: E-LUMINEXX VASCULAR AND BILIARY STENT
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5367137
• Report Number: 9681442-2016-00015
• Device Sequence Number: 16337590
• Product Code: NIO
• UDI-Device Identifier: 04049519009322
• UDI-Public: (01)04049519009322(17)180227(10)ANZB3769
• Combination Product (Y/N): N
• PMA/510(K) Number: P080007/S020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Report Date (Section B): 11/10/2015

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: 02/27/2018
• Device Catalogue Number: ZBM07060
• Device Lot Number: ANZB3769
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1