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

Catalog Number ZBM07060

Device Problems Positioning Failure (1158); Sticking (1597); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

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 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.

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
• Type of Device: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5367137
• MDR Text Key: 36353833
• Report Number: 9681442-2016-00015
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 04049519009322
• UDI-Public: (01)04049519009322(17)180227(10)ANZB3769
• Combination Product (y/n): N
• PMA/PMN Number: P080007/S020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2018
• Device Catalogue Number: ZBM07060
• Device Lot Number: ANZB3769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1