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

Catalog Number	FEM09040
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that during placement of the endovascular stent graft in the venous outflow of the basilic vein, the stent delivery system was advanced past the lesion site and then retracted to position the stent graft properly.Upon deployment, it was noticed that a majority of the stent graft had already been released.After completion of the deployment, it was noticed that the stent graft was improperly positioned.Another stent graft was used to complete the procedure.There was no reported patient injury.
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.On the basis of the condition of the returned delivery system, no device deficiency leading to any deployment difficulties and subsequent malposition of the stent graft was identified.As no images showing the location of the implanted stent graft were provided, the alleged malposition of the stent graft could not be reproduced.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaint have been reviewed.A difficult vessel anatomy may be a contributing factor to the reported event.Stent graft placement in tortuous or calcified vessels may lead to high friction and increased deployment forces resulting in an inaccurate stent graft deployment.Insufficient flushing of the device may be another contributing factor to the reported event.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be determined.The ifu states that the device must be flushed with sterile saline.The ifu states: "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated" and "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." furthermore, the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion." and "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." in addition, the ifu addresses the adverse event of a stent graft misplacement.
Event or Problem Description
It was reported that during placement of the endovascular stent graft in the venous outflow of the basilic vein, the stent delivery system was advanced past the lesion site and then retracted to position the stent graft properly.Upon deployment, it was noticed that a majority of the stent graft had already been released.After completion of the deployment, it was noticed that the stent graft was improperly positioned.Another stent graft was used to complete the procedure.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6475441
• Report Number: 9681442-2017-00133
• Device Sequence Number: 13545879
• Product Code: PFV
• UDI-Device Identifier: 04049519008530
• UDI-Public: (01)04049519008530(17)191110(10)ANAY1381
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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: 11/10/2019
• Device Catalogue Number: FEM09040
• Device Lot Number: ANAY1381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 05/25/2017
• 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: 63 YR
• Patient Weight: 64