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

Catalog Number	FEM08060
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 procedural details.
Event or Problem Description
It was reported that during a stent placement procedure, the endovascular stent graft would not disengage from the delivery system catheter during the attempt to deploy the stent graft.Another stent 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.On the basis of the evaluation of the returned device, the reported deployment failure could be confirmed.The stent graft was found to be partially released and the outer sheath was found to be perforated by a stent graft strut making successful stent graft deployment impossible.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The evaluation of the returned device revealed that the stent graft could not be fully deployed due to a stent strut perforating the distal outer sheath of the delivery system which may be associated with a difficult vessel anatomy or challenging placement site leading to increased friction and subsequent deployment difficulties.In this case, no information about the vessel anatomy was provided.Not using an introducer sheath or the use of an inappropriately sized guide wire also may contribute to tip damage and subsequent perforation.Insufficient flushing of the device may be another contributing factor to increased friction and subsequent device damage.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." 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.Also the ifu indicates 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.".
Event or Problem Description
It was reported that during a stent placement procedure, the endovascular stent graft would not disengage from the delivery system catheter during the attempt to deploy the stent graft.Another stent 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: 6135267
• Report Number: 9681442-2016-00313
• Device Sequence Number: 16181383
• Product Code: PFV
• UDI-Device Identifier: 04049519008493
• UDI-Public: (01)04049519008493(17)190722(10)ANAU2962
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/04/2016

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: 07/22/2019
• Device Catalogue Number: FEM08060
• Device Lot Number: ANAU2962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 66