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

Model Number	FEM08060
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot 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 to bard.
Event or Problem Description
It was reported that during a stenting procedure of the middle basilic vein via access through an upper arm fistula, the endovascular stent graft was found to be incompletely expanded post deployment.Therefore, an additional stent was placed inside the endovascular stent graft to expand it and maintain it open.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.No sample was returned.On the basis of the images provided, the reported event could be confirmed.The image shows the proximal 1/3 of the stent graft to be incompletely expanded compared to the distal part.Another stent graft was implanted for treatment of the not fully expanded stent graft segment.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may be associated with a difficult or challenging stent placement site.In this case, no difficulties were experienced during stent deployment and pre- and post-dilation was performed.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be determined.The ifu supplied with this product states that both ports of the device must be flushed with sterile saline.The ifu states: "pre-dilate the lesion and confirm that the stenosed lumen can be dilated to the desired diameter." and "post-dilate the stent graft with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel." in addition, the ifu indicates that an introducer sheath of appropriate inner diameter is required for the procedure as well as a balloon angioplasty catheter for pre and/or post dilation." also the ifu states that careful attention should be paid to ensure that the device is appropriately sized to the achievable lumen, taking into account any change to the stated treatment area diameter that may have resulted from previous interventions.
Event or Problem Description
It was reported that during a sheathless stenting procedure of a pre-dilated lesion in the middle basilic vein via access through an upper arm fistula, the endovascular stent graft was found to be incompletely expanded post deployment.Post-dilation with several balloons was unsuccessful to open the not fully expanded stent graft segment.Therefore, an additional stent was placed inside the endovascular stent graft to expand it and maintain it open.The diameter of the lesion was reported to be 8 mm and neither the tracking anatomy nor the target lesion was reported to be tortuous or calcified.The user had no difficulties in advancing the delivery system to the target site.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: 6569290
• Report Number: 9681442-2017-00181
• Device Sequence Number: 10950122
• Product Code: PFV
• UDI-Device Identifier: 04049519008493
• UDI-Public: (01)04049519008493(17)190930(10)ANAW4207
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

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: 09/30/2019
• Device Model Number: FEM08060
• Device Catalogue Number: FEM08060
• Device Lot Number: ANAW4207
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 07/28/2017
• 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: 81 YR
• Patient Weight: 59