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

Catalog Number	FEM08060
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2015
Type of Reportable Event	Serious Injury
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 immediately post deployment of the endovascular stent graft in a basilic vein fistula, the stent graft jumped 2 - 3 cm.An additional stent graft was placed to cover the original intended location completely.No patient injury was reported.
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.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample was returned.On the basis of the images provided, the reported stent graft malposition more distal than intended could be confirmed.An additional stent graft was placed in overlap to cover the lesion completely.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaint have been reviewed.A difficult vessel anatomy may contribute to the reported malposition of the stent graft.Stent graft placement in tortuous or calcified vessels may lead to high friction and increased deployment forces causing an inaccurate deployment.In this case, the lesion was reported to be tight.As the deployment process is not visible on the images, it could not be verified whether the stent graft deployment was difficult.Also an inappropriately sized stent graft may be a contributing factor to this type of event.As reported, the stent graft diameter corresponds to the reference size of the vessel.On the basis of the information available and the evaluation of the images, a definitive root cause for the reported event could not be determined.The ifu states: "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated." and "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: 5393926
• Report Number: 9681442-2016-00027
• Device Sequence Number: 471495
• Product Code: PFV
• UDI-Device Identifier: 04049519008493
• UDI-Public: (01)04049519008493(17)180921(10)ANZI2733
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130029/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2018
• Device Catalogue Number: FEM08060
• Device Lot Number: ANZI2733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2016
• Supplement Report FDA Received Date: 04/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR