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

Model Number	FEM08060
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional 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 any further patient details.
Event or Problem Description
It was reported that during a stenting procedure for treatment of a pseudoaneurysm in a right femoral dialysis graft (arterial side) via access through the left upper arm, the endovascular stent graft only partially deployed and did not fully release from the delivery system.Therefore, the device was removed without incident and another endovascular stent graft of larger size was used to complete the procedure successfully.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.The condition of the returned delivery system confirmed the reported event.The stent graft was found to be partially deployed upon sample receipt.During the performed function test, the stent graft could not be deployed any further.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 also may contribute to this type of event.In this case, no introducer sheath was used during the procedure which may be another contributing factor to the reported event.On the basis of the information available and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.The ifu supplied with this device states that both ports 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 indicates that an introducer sheath of appropriate inner diameter is required for the procedure.In addition, 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 ifu states that the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated.
Event or Problem Description
It was reported that during a stenting procedure for treatment of a pseudoaneurysm in a right femoral dialysis graft (arterial side) via access through the left upper arm, the endovascular stent graft only partially deployed and did not fully release from the delivery system.Therefore, the device was removed without incident and another endovascular stent graft of larger size was used to complete the procedure successfully.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: 6537157
• Report Number: 9681442-2017-00163
• Device Sequence Number: 13471445
• Product Code: PFV
• UDI-Device Identifier: 04049519008493
• UDI-Public: (01)04049519008493(17)190722(10)ANAU2983
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2019
• Device Model Number: FEM08060
• Device Catalogue Number: FEM08060
• Device Lot Number: ANAU2983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR