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

Catalog Number FEM12080

Device Problems Positioning Failure (1158); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure to treat an iliac artery aneurysm, the outer sheath of the delivery system began to stretch and the stent graft could not be deployed.The delivery system was removed over the guide wire without difficulty.Another stent graft was used to complete the procedure successfully.There is no reported patient injury.

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 patient details.

Manufacturer Narrative

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.Based on the sample evaluation, the reported failure to deploy the stent graft could be confirmed.The stent graft was found still completely loaded in the system.Furthermore, the outer sheath was found to be elongated, which indicates that increased friction affected the delivery system during attempt of stent graft deployment.As part of the sample evaluation the stent graft could be deployed.No indication was found for manufacturing related issues.Potential factors which may have contributed to the reported issue have been considered.Therefore previous investigations of similar complaints have been reviewed.This type of event may be associated with a difficult patient anatomy, which led to increased friction and the subsequent failure to deploy the stent graft.Based on the information available and the evaluation of the sample returned a definite root cause for the reported failure could not be determined.The instructions for use (ifu) which are applicable for this product were reviewed and it was found that the potential risks were sufficiently addressed.The ifu states: "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." according to the instruction for use supplied with this product, the product is indicated for treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft.The safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated.The reported application represents an off-label use of the device.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 ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4859182
• MDR Text Key: 5875724
• Report Number: 9681442-2015-00072
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2017
• Device Catalogue Number: FEM12080
• Device Lot Number: ANYL2771
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1