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

Catalog Number ZVL12100

Device Problems Positioning Failure (1158); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

The lot history records were 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 contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This type of event may be related to a difficult vessel anatomy or a challenging stent placement site.In this case, no procedural or anatomical details were provided.As reported, the device was removed from the patient with force which can be an indication for a difficult vessel anatomy.In addition, the stent was intended to be used for a tips procedure which represents an off-label use of the device and is considered a contributing factor to the reported deployment difficulties.The reported event also may be related to rough handling of the device during shipping, storage or preparation.On the basis of the limited 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 (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit." in addition, the ifu states that the e-luminexx vascular stent is indicated for use in the iliac and femoral arteries.Although this product is not sold in the u.S., this event is being reported under regulation 21cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under # p080007.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 or unwilling to provide any further procedural details to bard.

Event Description

It was reported that the vascular stent could not be released during a tips (transjugular intrahepatic portosystemic shunt) procedure.The device was removed from patient with force and another stent was placed successfully.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.There is no indication for a manufacturing-related failure.During the evaluation of the returned delivery system, the stent was found to be partially deployed and the distal end of the stent was found to be torn off.In addition, a stent strut was found to have perforated the outer sheath preventing the stent from complete deployment.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This type of event may be related to a difficult vessel anatomy or a challenging stent placement site.In this case, no procedural or anatomical details were provided.As reported, the device was removed from the patient with force which may be an indication for a difficult vessel anatomy.Additionally, the stent was intended to be used for a tips procedure which represents an off-label use of the device and is considered a contributing factor to the reported deployment difficulties.During sample evaluation, a stent strut was found to have perforated the outer sheath.This kind of damage may be caused by the contributing factors considered above, e.G., a tortuous tracking path or placement site in a kinked area may cause a damage to the tip of the outer sheath and subsequent perforation of the sheath material.The reported event also may be related to rough handling of the device during shipping, storage or preparation.On the basis of the information available and the evaluation of the sample, 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 (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit." in addition, the ifu states that the e-luminexx vascular stent is indicated for use in the iliac and femoral arteries.Updated data due to sample receipt.

Event Description

It was reported that the vascular stent could not be released during a tips (transjugular intrahepatic portosystemic shunt) procedure.The device was removed from patient with force and a another stent was placed successfully.There was no reported patient injury.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstr. 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6276335
• MDR Text Key: 65708960
• Report Number: 9681442-2017-00023
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: ZVL12100
• Device Lot Number: ANYA3313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2014
• 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: 58 YR
• Patient Weight: 75