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

Catalog Number	FEM06120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2016
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 further patient details.
Event or Problem Description
It was reported that during stenting of the radial artery via access through an upper arm fistula, the endovascular stent graft failed to deploy.It was further reported that a breakage of the delivery system sheath was noticed.The delivery system was removed and exchanged by a device of the same brand and size which also failed to deploy.Another stent was used to complete the procedure successfully.There was no reported patient injury.This is the same patient as reported in medwatch report # 9681442-2016-00142.
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 evaluation of the returned sample confirmed the reported event.The stent graft was found to be loaded in the delivery system and the outer sheath was found to be elongated and fractured 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 sheath fracture.Insufficient flushing of the device may be another contributing factor to the reported event.Reportedly, no introducer sheath was used during the procedure which can be another potential contributing factor.On the basis of the information available, a definite root cause for the reported event 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." the ifu indicates that an introducer sheath with appropriate inner diameter is required for the procedure.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." and "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed." the reported application represents an off-label use of the device which is indicated for use in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (a/v) fistula or a/v graft.

• 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: 5687642
• Report Number: 9681442-2016-00141
• Device Sequence Number: 18988189
• Product Code: PFV
• UDI-Device Identifier: 04049519008424
• UDI-Public: (01)04049519008424(17)170612(10)ANYF1712
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P130029/S001
• 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): 05/02/2016

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: 06/12/2017
• Device Catalogue Number: FEM06120
• Device Lot Number: ANYF1712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2016
• Supplement Report FDA Received Date: 06/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR