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

Catalog Number	FEM14120
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Vascular System (Circulation), Impaired (2572)
Date of Event	05/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that during stenting of a right upper arm fistula via upper arm access, the endovascular stent graft could not be deployed.The device was removed and three stent grafts of the same brand but smaller size were used instead to complete the procedure successfully.There was no reported patient injury.This is the same patient as reported in medwatch report # 9681442-2016-00172 and 9681442-2016-00173.
Additional 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.There is no indication for a manufacturing-related failure.The condition of the returned device confirmed the reported deployment failure.The stent graft was found to be partially released and the outer sheath was found to be elongated indicating that increased friction must have affected on the delivery system during the attempt to deploy the stent graft.Potential contributing factors 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 partial stent graft deployment.Insufficient flushing of the device may be another contributing factor to the reported event.On the basis of the information available, a definite root cause for the reported failure 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." the reported application represents an off-label use of the device which is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (a/v) fistula or a/v graft.The safety and effectiveness of the device for a treatment as described has not been evaluated.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5741803
• Report Number: 9681442-2016-00174
• Device Sequence Number: 10769067
• Product Code: PFV
• UDI-Device Identifier: 04049519008721
• UDI-Public: (01)04049519008721(17)181120(10)ANZK2847
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: S130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2018
• Device Catalogue Number: FEM14120
• Device Lot Number: ANZK2847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2016
• Supplement Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR