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

Catalog Number	FEM10080
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
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 a sheathless stent graft placement procedure for treatment of a pre-dilated left subclavian vein stenosis (the patient had a left upper arm graft), the endovascular stent graft could not be deployed.Reportedly, resistance was felt when trying to release the stent graft.The device was removed and another stent graft of the same brand 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.Based on the condition of the returned sample, the reported event was confirmed.The stent graft was found to be partially deployed upon sample receipt; the outer sheath of the delivery system was found to be fractured.The condition of the sample, in particular elongation and fracture of the outer sheath indicates that high friction forces occurred during the attempt to deploy the stent graft.Based on sample evaluation no indication was found that a manufacturing related issue may have caused this event.Previous investigations of similar complaints have been reviewed.The reported type of event may be associated with a difficult patient anatomy or a challenging placement site.Usage of inadequate accessories or insufficient flushing of the device prior to use may be contributing factors.On the basis of the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be identified.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." regarding preparation of the device the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment." regarding the anatomy of the placement site 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.¿ regarding use of accessories the ifu states: "material required for the fluency plus endovascular stent graft procedure (.) introducer sheath with appropriate inner diameter.".
Event or Problem Description
It was reported that during a sheathless stent graft placement procedure for treatment of a pre-dilated left subclavian vein stenosis (the patient had a left upper arm graft), the endovascular stent graft could not be deployed.Reportedly, resistance was felt when trying to release the stent graft.The device was removed and another stent graft of the same brand 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; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6022175
• Report Number: 9681442-2016-00266
• Device Sequence Number: 348086
• Product Code: PFV
• UDI-Device Identifier: 04049519008608
• UDI-Public: (01)04049519008608(17)190429(10)ANAR4165
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2016

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: 04/29/2019
• Device Catalogue Number: FEM10080
• Device Lot Number: ANAR4165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 77