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

Model Number ZBM08060

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2017

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 further procedural details to bard.

Event Description

It was reported that during advancement into the lesion in the right external iliac, resistance was felt and during an attempt to deploy the stent notch would not lock.It was attempted to manually deploy the stent with unsuccessful results; therefore, the delivery system was removed and upon removal the stent elongated.There was no reported patient injury.

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 sample was not available for return and no images were provided for evaluation.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.As reported, resistance was felt during system advancement to the lesion site and manual deployment was not possible.This kind of event may be related to a difficult vessel anatomy leading to increased friction during advancement and during deployment.In this case, only limited information was provided regarding the patient anatomy and the patient's condition.The reported elongation of the stent may have occurred as a consequence of the removal of the system with the partially deployed stent.On the basis of the information available and as no sample 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." furthermore, the ifu states: "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 Description

It was reported that during advancement of the delivery system to the lesion site in the right external iliac artery, resistance was felt and during the attempt to deploy the stent, the notch would not lock.An attempt to deploy the stent manually was unsuccessful, too.Therefore, the delivery system was removed.Upon removal of the system from the patient, the stent elongated.There was no reported patient injury.

• 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: 6622685
• MDR Text Key: 77011794
• Report Number: 9681442-2017-00193
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 04049519009384
• UDI-Public: (01)04049519009384(17)191110(10)ANAY1299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080007
• 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: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2019
• Device Model Number: ZBM08060
• Device Catalogue Number: ZBM08060
• Device Lot Number: ANAY1299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2016
• 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
• Patient Age: 70 YR