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

Catalog Number FEM10100

Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the endovascular stent graft could not be deployed during the procedure.There was 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 or unwilling to provide any patient or procedural details to date.

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 condition the reported failure could be confirmed.The stent graft was found completely loaded in system and could not be deployed during stent graft deployment test.Furthermore, the inner catheter was found to be detached; however, further information regarding the detachment was not provided.No indication was found for manufacturing related issue.Potential factors which may have contributed to the reported issue have been considered.Therefore previous investigations of similar complaints have been reviewed.It was reported that the stent graft failed to deploy and also the inner catheter was found to be detached upon sample evaluation.This type of event may be associated with a difficult patient anatomy, which led to increased friction during stent graft deployment and alleged removal difficulties.Insufficient flushing of the device could be another contributing factor.In this case no procedural information was provided.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported failure could not be determined.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 endovascular 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: "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.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." regarding possible retraction difficulty the ifu states: "if resistance is encountered removing the delivery system, it is recommended to remove the delivery system, introducer and guidewire as a single unit.After removing the delivery system, visually confirm that the complete system has been removed.(.) (a) inner catheter with distal flared end (.)".In this case no procedural information was provided.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: daneila mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4867997
• MDR Text Key: 5860151
• Report Number: 9681442-2015-00080
• 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: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2017
• Device Catalogue Number: FEM10100
• Device Lot Number: ANYL1851
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2015
• 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