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

Model Number FEM10060

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 stent graft deployment procedure intended for the stenosis at the junction of the right subclavian vein and the brachial cephalic vein with access through the fistula, the stent graft allegedly partially deployed about five millimeters and the outer sheath of the delivery system fractured.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

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.No indication was found for a manufacturing related issue.No additional complaint has been reported for this lot number previously.Based on the condition of the returned sample the reported issue could be confirmed.The stent graft was found partially deployed and the outer sheath was found elongated which indicates that increased friction affected the delivery system during attempt of stent graft deployment and finally led to the fracture of the outer sheath.This fracture makes a stent graft deployment impossible.Potential factors which may have caused or contributed to the reported issue have been considered.However, based on the information available and the evaluation of the sample returned, a definite root cause for the reported event 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.".

Event Description

It was reported that during a stent graft deployment procedure intended for the stenosis at the junction of the right subclavian vein and the brachial cephalic vein with access through the fistula, the stent graft allegedly partially deployed about five millimeters and the outer sheath of the delivery system fractured.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

• 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; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7073322
• MDR Text Key: 93728306
• Report Number: 2020394-2017-01676
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008592
• UDI-Public: (01)04049519008592
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2020
• Device Model Number: FEM10060
• Device Catalogue Number: FEM10060
• Device Lot Number: ANBT0867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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
• Patient Age: 59 YR
• Patient Weight: 77