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

Catalog Number ZVL06120

Device Problems Occlusion Within Device (1423); Insufficient Information (3190)

Patient Problems Occlusion (1984); Tissue Damage (2104); Stenosis (2263); Claudication (2550)

Event Date 06/19/2015

Event Type  Injury  

Event Description

It was reported two vascular stents were placed in an overlap of 1 cm in (b)(6) 2014 to treat a long occlusion of the right common femoral artery and right superficial femoral artery.The stent deployment was successful; angiography showed good patency and no residual stenosis.Six months post stent implantation, restenoses in both stents were found.In (b)(6) 2015, the patient's right leg was amputated.This file refers to the distal stent.This is the same patient as reported in medwatch report # 9681442-2015-00103.

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.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 to provide further patient details.

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 was returned.On the basis of the images provided, no indication for an irregular stent placement or stent defect was found.The images confirmed the re-occlusion of the vessel 6 months post stent implantation, however, no indication for a device-related vessel occlusion was found.Potential contributing factors have been evaluated.As the reported event was found to be an isolated incident, no previous investigations of similar complaints could have been reviewed.This type of event may be caused by various factors and is associated with the vessel anatomy and/or the individual physiological mechanisms.Although the overlapping stents had different diameters which contradicts the ifu, there is no evidence that the re-occlusion of the stented segment was caused by the overlapping stents of different diameters.Based on the information available and the images, a definite root cause for the event reported could not be determined.The ifu states: "potential adverse events associated with the use of the bard e-luminexx vascular stent include, but may not be limited to the usual complications reported for vascular procedures such as restenosis, recurrent narrowing or occlusion of stented segment, stent thrombosis / occlusion and vessel total occlusion." also the ifu states: "if placing two overlapping stents, both stents must have identical diameters.".

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR 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: 4937947
• MDR Text Key: 6035001
• Report Number: 9681442-2015-00102
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: ZVL06120
• Device Lot Number: ANXG3119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2013
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR