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

Catalog Number FVL14100

Device Problems Positioning Failure (1158); Fracture (1260); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer; however a photo was provided and a photo review will be performed.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation to date.The investigation of the reported event is currently underway.The catalog number identified in section 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.Accordingly, this event has been determined to be mdr reportable.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.

Event Description

It was reported that during a two-stent graft deployment procedure intended for the iliac arteries by overlapping a previously placed stent graft with access through the left brachial artery, the outer sheath of the delivery system allegedly fractured and the stent allegedly partially deployed by one centimeter.Reportedly, the tracking anatomy of the vessel was tortuous and excessive force was necessary to start stent graft deployment.Furthermore, the device was removed as one unit with no issue and another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during a two-stent graft deployment procedure intended for the iliac arteries by overlapping a previously placed stent graft with access through the left brachial artery, the outer sheath of the delivery system allegedly fractured and the stent allegedly partially deployed by one centimeter.Reportedly, the tracking anatomy of the vessel was tortuous and excessive force was necessary to start stent graft deployment.Furthermore, the device was removed as one unit with no issue and another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.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: stent graft delivery system was not returned for evaluation.However, two photos of the device take in the operating room were provided by the customer.Based on the photos partial deployment of the stent graft as well as elongation of the outer sheath could be confirmed elongation of the outer sheath may be an indication for increased deployment forces during the attempt to deploy the stent graft.Based on photos provided, no indication for a manufacturing related cause could be identified.Potential factors which may have caused or contributed to the reported issue have been considered.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The intended treatment of an aneurysm represents an off label use of the device.However, based on the information available and the photos provided, 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.Regarding preparation of the device the ifu states that "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." regarding the anatomy of the placement site 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." the intended treatment of an aneurysm represents an off label use of the device.Based on the ifu provided with this product, the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.

• 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: 7143357
• MDR Text Key: 95803313
• Report Number: 9681442-2017-00314
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145360
• UDI-Public: (01)00801741145360
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: FVL14100
• Device Lot Number: ANAY1413
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR