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

Catalog Number UNK E-LUMINEXX VASCULAR STENT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Journal article review: the article is a retrospective review of 38 patients that underwent deep vein stenting of 44 limbs with history of venous ulcers.Lesions were considered to be post-thrombotic in 31 limbs and non-thrombotic iliac vein lesions in 13 limbs.There were no significant complications associated with the interventions.At a 15 month follow-up, primary and assisted primary patency rates were 94 to 97%.Sustained ulcer healing was achieved with 60% of the limbs, 20% of the ulcers were reduced in size.Recurrent ulcers develop and 13% of the limbs and half of these healed with interventions for newly developed incompetence of superficial veins.Stents used for these procedures were either a taewoong niti stent or bard e-luminexx stents.Outcomes: procedure related complications included extravasation or contrast due to venous perforation in three patients with venous occlusions.Follow up: venous doppler at six weeks demonstrated one stent occlusion.A 13 month follow-up one patient required intervention for a new ulcer with evidence of more caudal disease which was treated by placing an additional stent.George, r., verma, h., ram, b., & tripathi, r.(2014).The effect of deep venous stenting on healing of lower limb venous ulcers.European society for vascular surgery, 48(3), 330-336.Http://dx.Doi.Org/10/1016/j.Ejvs.2014.04.031.

Event Description

It was reported in an article in european society of vascular surgery titled 'the effect of deep venous stenting on healing of lower limb venous ulcers', that a retrospective review for 38 patients that underwent deep vein stenting of 44 limbs with history of venous ulcers.At a 15 month follow-up, primary and assisted primary patency rates were 94 to 97%.Sustained ulcer healing was achieved with 60% of the limbs, 20% of the ulcers were reduced in size.One procedure complication of venous perforation during stent deployment.

Manufacturer Narrative

H10: manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Journal article review: the article is a retrospective review of 38 patients that underwent deep vein stenting of 44 limbs with history of venous ulcers.Lesions were considered to be post-thrombotic in 31 limbs and non-thrombotic iliac vein lesions in 13 limbs.There were no significant complications associated with the interventions.At a 15 month follow-up, primary and assisted primary patency rates were 94 to 97%.Sustained ulcer healing was achieved with 60% of the limbs, 20% of the ulcers were reduced in size.Recurrent ulcers develop and 13% of the limbs and half of these healed with interventions for newly developed incompetence of superficial veins.Stents used for these procedures were either a taewoong niti stent or bard e-luminexx stents.Outcomes: procedure related complications included extravasation or contrast due to venous perforation in three patients with venous occlusions.Follow up: venous doppler at six weeks demonstrated one stent occlusion.A 13 month follow-up one patient required intervention for a new ulcer with evidence of more caudal disease which was treated by placing an additional stent.George, r., verma, h., ram, b., & tripathi, r.(2014).The effect of deep venous stenting on healing of lower limb venous ulcers.European society for vascular surgery, 48(3), 330-336.Http://dx.Doi.Org/10/1016/j.Ejvs.2014.04.031.Investigation summary: a physical sample was not available for evaluation.One x-ray image was part of the journal article demonstrating a lesion before and after stent placement.A device deficiency or vessel deformation related to the alleged perforation could not be identified on the image which led to an inconclusive evaluation result.Vessel perforation may be related to incorrect handling of the system during deployment.Difficult patient condition, challenging placement site, or tortuous anatomy may be contributing factors.In this case the stent was placed in the venous system, which represents an off label use.A manufacturing related issue was considered, however, a lot number was not reported so that a manufacturing review was not possible.Based on the information available a definite root cause for the event reported could not be identified.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed as the instructions for use (ifu) state: 'pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician.' regular deployment of the stent was found sufficiently described.Furthermore, 'hemorrhage, with or without transfusion', and 'vessel tear, dissection, perforation, or rupture' was mentioned as a potential adverse event that may occur.The reported application represented an off label use of the device.Based on the ifu supplied with this product, the device is intended for use in the iliac and femoral arteries.

Event Description

It was reported in an article in the european society of vascular surgery titled, ¿the effect of deep vein stenting on healing of lower limbs venous ulcers¿, that a retrospective review for 38 patients that underwent deep vein stenting of 44 limbs with history of venous ulcers.At a 15 month follow-up, primary and assisted primary patency rates were 94 to 97%.Sustained ulcer healing was achieved with 60% of the limbs, 20% of the ulcers were reduced in size.Procedure-related complications included extravasation of contrast due to presumed venous perforation in three patients with venous occlusions.None of these events were associated with hemodynamic instability, the need for blood transfusions, or other clinical consequences.

• 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
• MDR Report Key: 8157888
• MDR Text Key: 131377617
• Report Number: 9681442-2018-00215
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK E-LUMINEXX VASCULAR STENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1