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

Catalog Number	FEM08120
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/15/2015
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 / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that a plastic piece just fell apart upon loosening the tuohy.As reported, this happened while the device was inserted into the patient.The device was taken out of the patient and the procedure was completed by using another device of the same brand and type.As reported the indication for the stent graft placement was a significant residual stenosis of a venous anastamosis of a left arm graft.The stent graft was not placed across a tight bend.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 delivery system was returned for evaluation.The stent graft was found to be still loaded in the system and the blue outer sheath was found to be fractured and elongated near the catheter reinforcement.As reported, a plastic piece fell apart upon loosening the tuohy; the condition of the sample indicates that this refers to the fractured blue outer sheath near the catheter reinforcement distal the tuohy borst adapter.The condition of the device indicates that high friction must have affected on the 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 deployment.Insufficient flushing of the device may be another 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." 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.".

• 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: 5480737
• Report Number: 9681442-2016-00066
• Device Sequence Number: 625157
• Product Code: PFV
• UDI-Device Identifier: 04049519008523
• UDI-Public: (01)04049519008523(17)180627(10)ANZF3013
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2015

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: 06/27/2018
• Device Catalogue Number: FEM08120
• Device Lot Number: ANZF3013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2016
• Supplement Report FDA Received Date: 04/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 128