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

Catalog Number FVL06120

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation 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 the vascular stent graft allegedly failed to deploy from the delivery system during treatment in the renal artery via the right and left axillary artery access.It was further reported that resistance was felt during an attempt to deploy the stent that it catheter sheath allegedly fractured.Reportedly, the device was removed without incident and four smaller in size stents were used instead of two long stents to complete the procedure resulting in a prolongation of the procedure and patient exposure under anesthesia.There was no reported patient injury.

Manufacturer Narrative

As the sample was not returned a manufacturing related cause could not be verified.The lot history 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.There was no relevant manufacturing process changes that could have led to the reported event.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case no sample and no images were provided for evaluation.Therefore, the reported problem could not be reproduced and the investigation was closed with inconclusive results.The reported application presents an off label use of the device.However, based on the available information and as no sample was 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 factors for the reported failure to deploy.The ifu states: "prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline.Flushing these lumens will also facilitate stent graft deployment." regarding difficult anatomy the ifu states: "prior to stent graft deployment in tortuous anatomy, 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 reported application presents an off label use of the device.Based on the ifu supplied with this product the fluency plus vascular stent graft is indicated for use in the femoral and iliac arteries.

Event Description

It was reported that the vascular stent graft allegedly failed to deploy from the delivery system during treatment in the renal artery via the right and left axillary artery access.It was further reported that resistance was felt during an attempt to deploy the stent causing an alleged catheter fracture.Reportedly, the device was removed without incident and four smaller in size stents were used instead of two long stents to complete the procedure resulting in prolongation of the procedure and patient exposure under anesthesia.There was no reported patient injury.

• Brand Name: FLUENCY PLUS STENT GRAFT
• Type of Device: VASCULAR 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: 7079716
• MDR Text Key: 93824525
• Report Number: 9681442-2017-00303
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741144998
• UDI-Public: (01)00801741144998
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2018
• Device Catalogue Number: FVL06120
• Device Lot Number: ANZI2764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2015
• 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