MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT - MT-6F-ZVL 12/100/135; E-LUMINEX STENT

Catalog Number ZVL12100

Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing related cause was considered; however, 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 the specification prior to shipment.Investigation summary: the sample was not available for evaluation.Images have been provided demonstrating the used sample after the event; the stent was visibly undeployed and the proximal luer adapter was found detached from the grip which made a successful deployment using the trigger impossible.It was not known when and how the conversion tab was removed from the grip.Based on photos provided the proximal luer adapter was found detached and the conversion tab was missing.This event may be related to inadequate handling during transport, storage, unpacking, or preparation (especially flushing).High release force or insertion force caused by difficult anatomy may be a contributing factor.It was not known when and how the conversion tab was removed.In this case the lesion was pre dilated and the product was used off label in the vena cava.Based on the information available the investigation is confirmed for luer adapter detachment and conversion tab missing.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use sufficiently address the potential risk: 'visually inspect the bard e-luminexx vascular stent system 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.' regarding conversion tab removal for not using the grip the ifu state: "do not remove the white conversion tab (m) unless you have selected 'the conventional method' for stent deployment." the intended use of the device for treatment of the vena cava represents an off label use of the device.Based on the ifu supplied with this product, the bard® e-luminexx® vascular stent is indicated for use in the iliac and femoral arteries.(expiration date: 12/2020).

Event Description

It was reported that during the stent placement through right jugular sector, the stent allegedly not released and detached.The procedure was completed using another stent.There was no reported patient injury.

• Brand Name: E-LUMINEXX VASCULAR STENT - MT-6F-ZVL 12/100/135
• Type of Device: E-LUMINEX STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10424750
• MDR Text Key: 204757209
• Report Number: 9681442-2020-00195
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146527
• UDI-Public: (01)00801741146527
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P08007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: ZVL12100
• Device Lot Number: ANBZ1041
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2018
• 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