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

Catalog Number FEM10080

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.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.

Event Description

It was reported that the endovascular stent graft could not be deployed in the cephalic vein for treatment of a brachiocephalic fistula via access through the fistula.Reportedly, the tight stenosis had been pre-dilated with two balloons.There was no reported patient injury.This is the same patient as reported in medwatch report # 9681442-2016-00302.

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 or image was provided for evaluation.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This kind of event may be related to a difficult vessel anatomy or a challenging placement site.As reported, the stenosis was rather tight and a pre-dilation had been performed.Insufficient flushing of the device may be another contributing factor to this type of event.On the basis of the information available and as no sample was returned, a definite root cause for the reported event could not be determined.The ifu states that the device must be flushed with sterile saline.Also the ifu states: "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure" and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." furthermore, the ifu states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.".

Event Description

It was reported that the endovascular stent graft could not be deployed in the cephalic vein for treatment of a brachiocephalic fistula via access through the fistula.Reportedly, the tight stenosis had been pre-dilated with two balloons.There was no reported patient injury.This is the same patient as reported in medwatch report # 9681442-2016-00302.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• 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: 6124056
• MDR Text Key: 60755907
• Report Number: 9681442-2016-00301
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008608
• UDI-Public: (01)04049519008608(17)180820(10)ANZH1997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2018
• Device Catalogue Number: FEM10080
• Device Lot Number: ANZH1997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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): Required Intervention
• Patient Age: 81 YR