MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT

Catalog Number UNK FLUENCYPLUS VASC STNT GRFT

Device Problem Obstruction of Flow (2423)

Patient Problems Unspecified Infection (1930); Thrombosis (2100)

Event Date 04/15/2016

Event Type  Injury  

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 journal article was a prospective randomized study to include patients from the vascular access center at the general facility hospital in prague.The study of 46 patients with stenosis of venous anastomosis or outflow vein of the dialysis shunt with prosthesis from july 2013 through may 2015.The criteria for the patient¿s included: failing dialysis shunt with prosthesis, hemodynamically significant early restenosis of venous anastomosis and/or the outflow vein from elbow to auxiliary vein (restenosis repeated at least twice within one to three months, stenosis of 50% or more was considered significant), expected survival of more than a year.The stents used in the study were bard e-luminexx and bard fluency plus.Complications: a 12 month follow-up, six patients reported with recurrent thrombosis, one patient was reported with infection, and 14 patients had angioplasty post stent graft deployment.When patient experienced repeated thrombosis of this shunt, complicated by a stent fracture in the venous anastomosis during percutaneous thrombectomy.Consequently, the proximalization of the venous anastomosis was performed by a surgeon.One patient shunt completely closed at day 153 because of irresolvable shunt thrombosis due to a critical condition.The patient passed away due to a generalized bladder tumor at day 184 post stent deployment.Kavan, j., kudlicka, j., krivanek, j., forejtova, l., matras, p., padrta, t., slavikova, m.,.& malik, j.(2016).Comparison of one-year patency rate and cost-effectiveness of stent graft vs.Stent vs.Pta in dialysis av graft.Czech radiology, 70(2), 78-84.

Event Description

It was reported in the czech radiology in an article titled, ¿comparison of one-year patency rate and cost-effectiveness of the stent graft versus stent versus pta in dialysis av graft¿, that a retrospective randomized study from 2013 to 2015 included 46 patients with history of stenosis at the venous anastomosis.Complications reported at the 12 month follow-up included recurrent thrombosis, one patient reported with infection, and four patients had angioplasty.

Manufacturer Narrative

Manufacturing review: no specific lot number was reported.Therefore a detailed review of specific lot history records could not be performed to determine if any potential manufacturing related issues occurred, that could be related to the reported events.Investigation summary: as no x-rays images were available, the reported restenosis of stent grafts could not be verified.A possible correlation with a potential product deficiency cannot be confirmed.In this case no x-rays were provided to verify the reported issue and a possible correlation of the reported in-stent restenosis with a potential product deficiency.The investigation of the issues described in the article will be closed with inconclusive result.Based on the information available a definite root cause for the issues described could not be identified.Journal article review: the journal article was a prospective randomized study to include patients from the vascular access center at the general facility hospital in prague.The study of 46 patients with stenosis of venous anastomosis or outflow vein of the dialysis shunt with prosthesis from july 2013 through may 2015.The criteria for the patient¿s included: failing dialysis shunt with prosthesis, hemodynamically significant early restenosis of venous anastomosis and/or the outflow vein from elbow to auxiliary vein (restenosis repeated at least twice within one to three months, stenosis of 50% or more was considered significant), expected survival of more than a year.The stents used in the study were bard e-luminexx and bard fluency plus.Complications: a 12 month follow-up, six patients reported with recurrent thrombosis, one patient was reported with infection, and 14 patients had angioplasty post stent graft deployment.When patient experienced repeated thrombosis of this shunt, complicated by a stent fracture in the venous anastomosis during percutaneous thrombectomy.Consequently, the proximalization of the venous anastomosis was performed by a surgeon.One patient shunt completely closed at day 153 because of irresolvable shunt thrombosis due to a critical condition.The patient passed away due to a generalized bladder tumor at day 184 post stent deployment.Kavan, j., kudlicka, j., krivanek, j., forejtova, l., matras, p., padrta, t., slavikova, m.,.& malik, j.(2016).Comparison of one-year patency rate and cost-effectiveness of stent graft vs.Stent vs.Pta in dialysis av graft.Czech radiology, 70(2), 78-84.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed in the instructions for use (ifu).Potential complications such as thrombosis, early stent graft occlusion and restenosis were found to be addressed.The reported indication of treatment of a failing dialysis shunt with prosthesis represents an off label use of the device.Based on the ifu supplied with this product, the fluency® plus vascular stent graft is indicated to be used the in the iliac and femoral arteries.

Event Description

It was reported in an article in czech radiology titled, ¿comparison of one-year patency rate and cost-effectiveness of the stent graft versus stent versus pta in dialysis av graft¿, that a retrospective randomized study from 2013 to 2015 included 46 patients with history of stenosis at the venous anastomosis.Complications reported at the 12 month follow-up included recurrent thrombosis, one patient reported with infection, and four patients had angioplasty.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8053679
• MDR Text Key: 126638519
• Report Number: 9681442-2018-00197
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCYPLUS VASC STNT GRFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention