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

Catalog Number UNK E-LUMINEXX VASCULAR STENT

Device Problems Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problems Occlusion (1984); Great Vessel Perforation (2152)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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): 330-6.Http://dx.Doi.Org/10/1016/j.Ejvs.2014.04.031.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.[(b)(4)].

Event Description

It was reported in an article in 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.One procedure complication of venous perforation during stent deployment and one stent occlusion post 13 month stent deployment.

Event Description

It was reported in an article in 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.One procedure complication of venous stent occlusion post 13 month stent deployment.

Manufacturer Narrative

H10: manufacturing review: no lot number was reported; a sample was not available.A review of manufacturing records was not performed, so that it was not known whether the reported issue was potentially related to production.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): 330-6.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 the lesion before and after stent placement.A device deficiency related to the alleged occlusion could not be identified on the image which led to an inconclusive evaluation result.In this case the stent was placed in the venous system, which represents an off label use.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.', and 'post-dilatation of the stent 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, 'stent thrombosis / occlusion' 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.

• 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: 7950011
• MDR Text Key: 123193965
• Report Number: 9681442-2018-00184
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• 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: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention