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

Catalog Number FEM14120

Device Problems Positioning Failure (1158); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during placement in the cannulation zone of an a/v graft, the endovascular stent graft could not be deployed any further after being partially released.Reportedly, some difficulties in advancing the delivery system to the target lesion were experienced.The delivery system was retracted without issue.No other device was used for completion of the procedure since another device was not available at that time.There was no reported patient injury.

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 was returned.On the basis of the images provided, the reported partial deployment of the stent graft could be confirmed.The reported difficulties in advancing the delivery system to the target lesion could not be reproduced on the basis of the images.Potential factors that could have led or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This type of event may be associated with a difficult vessel anatomy leading to increased friction and subsequent deployment failure.Insufficient flushing of the device may be another contributing factor to the reported event.No introducer sheath was used in this case which is considered another potential contributing factor to the reported 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 and recommends the use of an appropriately sized introducer sheath.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 stent graft end is positioned in a straight section of the lumen." 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." the reported application represents an off-label use of the device.The fluency plus endovascular stent graft is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft.The ifu states: "the effects of direct cannulation on the stent graft have not been evaluated in a clinical study.Notify the patient that the stent graft should not be cannulated and applying pressure to the implant area should be avoided.".

• 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: 5149446
• MDR Text Key: 28235315
• Report Number: 9681442-2015-00185
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008721
• UDI-Public: (01)04049519008721(17)180612(10)ANZF1450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2018
• Device Catalogue Number: FEM14120
• Device Lot Number: ANZF1450
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2015
• 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: 48 YR
• Patient Weight: 191