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

Catalog Number FVL08060

Device Problems Positioning Failure (1158); Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus endovascular stent graft products are identified in common name & product code and pma/510(k) number.As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that during a stent graft deployment procedure for an indirect portal venography via a right femoral vein approach, the outer catheter allegedly became stuck which led to the stent graft failing to deploy.It was further reported that the delivery system was retracted from the patient.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during a stent graft deployment procedure for an indirect portal venography via a right femoral vein approach, the outer catheter allegedly became stuck which led to the stent graft failing to deploy.It was further reported that the delivery system was difficult to advance as well as difficult to remove.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

This supplemental mdr is being submitted to report this event is no longer reportable as there was no break on the handle and no outer catheter fracture identified during evaluation of the device.The event is not mdr reportable.Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: the stent graft was returned for evaluation; the stent graft delivery system was not returned.Based on the returned stent graft, the reported issue could not be reproduced so the investigation will be closed with inconclusive result.A manufacturing related issue could not be identified.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks; the ifu states: 'prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' the ifu states: 'prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy.' regarding the use of accessories the ifu states 'a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure.' and also 'if resistance is felt in passing the introducer sheath, the flexible deployment system should be removed together with the introducer sheath.' the reported indication represents an off label use of the device.Based on the ifu supplied with this product the fluency plus vascular stent graft is intended for use in the iliac and femoral arteries.(device code & description 2, method 1, results 1).Section a through f - 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.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7985913
• MDR Text Key: 124832320
• Report Number: 9681442-2018-00187
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145100
• UDI-Public: (01)00801741145100
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: FVL08060
• Device Lot Number: ANBR3635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR