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

Catalog Number FEM12060

Device Problems Positioning Failure (1158); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.

Event Description

It was reported that during a stenting procedure, the endovascular stent graft could not be deployed.There was no reported patient injury.

Manufacturer Narrative

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 could be confirmed.The stent graft was found partially released and the outer sheath was found elongated, which indicates that increased released force was present during attempt of deployment.Furthermore, the outer sheath was found perforated by two stent graft struts, which made a stent graft deployment impossible.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.The evaluation of the sample returned showed that the stent graft could not be deployed due to stent graft struts perforating the distal outer sheath of the delivery system.This may have been associated with difficult anatomic conditions or challenging placement site, which led to increased friction and subsequent to damage of the outer sheath.Not using an introducer sheath or the use of an inappropriate guide wire may be contributing factors for an alleged damage of the tip of the delivery system and a subsequent perforation.In this case no details regarding the anatomy or accessories used were provided.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.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 of the same size." regarding the anatomy of the placement site the ifu states: "the safety and effectiveness of the device when placed across a tight bend including the terminal cephalic arch or across the elbow joint 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." regarding the use of accessories the ifu states: "the use of an appropriately sized introducer sheath is recommended.Prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location." furthermore, the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion.".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
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 4918733
• MDR Text Key: 22442451
• Report Number: 9681442-2015-00099
• 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
• Reporter Occupation: Physician
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2017
• Device Catalogue Number: FEM12060
• Device Lot Number: ANYG2454
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2014
• 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