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

Catalog Number	FEM08080
Medical Device Problem Codes	Positioning Failure (1158); Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2017
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 or procedural details to bard.
Event or Problem Description
It was reported that the endovascular stent graft could not be deployed.Reportedly, an undersized introducer sheath was used during the procedure resulting in the deployment failure.Another device 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.There is no indication for a manufacturing-related failure.The evaluation of the returned device revealed that the stent graft could not be fully deployed due to a stent graft strut perforating the distal outer sheath of the delivery system.The stent graft was found to be partially deployed.Furthermore, the outer sheath was found to be elongated 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.The event may be associated with a difficult vessel anatomy or a challenging stent placement site leading to increased friction and subsequent deployment difficulties.In this case, no information regarding the vessel anatomy and the stent placement site was provided.Not using an introducer sheath or the use of an inappropriate introducer sheath, or the usage of an improper guide wire also may contribute to tip damage and subsequent perforation.As reported, an undersized introducer sheath was used during the procedure.The size of the guide wire used is unknown.Insufficient flushing of the device prior to use may be another contributing factor to increased friction and subsequent damage to the device.On the basis of the information available and the evaluation of the sample, a definite root cause for the reported event could not be determined.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 of the same size." and "the safety and effectiveness of the device when placed across a tight bend including the terminal cephalic arch or across the elbow joint 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." also the ifu indicates that an introducer sheath with appropriate inner diameter and a 0.035" (0.89 mm) guide wire are required for the procedure, and that the device must be flushed with sterile saline.Furthermore, the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion." updated 'eval code & desc - conclusion' due to completion of evaluation.
Event or Problem Description
It was reported that the endovascular stent graft could not be deployed.Reportedly, an undersized introducer sheath was used during the procedure resulting in the deployment failure.Another device 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: 6314551
• Report Number: 9681442-2017-00052
• Device Sequence Number: 30373
• Product Code: PFV
• UDI-Device Identifier: 04049519008509
• UDI-Public: (01)04049519008509(17)190902(10)ANAW0481
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/04/2017

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: 09/02/2019
• Device Catalogue Number: FEM08080
• Device Lot Number: ANAW0481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1