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

Catalog Number FVL14100

Device Problems Positioning Failure (1158); Fracture (1260); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2017

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 catalog number identified in section has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus vascular stent graft products are identified.Accordingly, this event has been determined to be mdr reportable.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 placement procedure intended for the aneurysm in the iliac artery with access through the femoral artery, an increase of force was necessary to start the stent graft deployment, however, the stent allegedly failed to deploy.Reportedly.There was difficulty retracting the delivery system from the patient yet, the device was removed from the patient's body.Furthermore, it was observed that the stent has been stuck and after several attempts, the stent had deployed outside of the patient.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 additional complaint has been previously reported for this lot number.Based on the investigation of the returned catheter sample it could be confirmed that the outer sheath was fractured.The stent graft was returned as a separate piece as it reportedly was deployed after the event outside patient; a deployment failure was therefore not confirmed.Elongation was found on the outer sheath which led to the conclusion that a high release force had been exerted on the system before the outer sheath broke.It was not known whether the outer sheath fractured during use on patient or during several release attempts outside patient.The investigation will be closed as confirmed for sheath fracture.Potential factors which may have caused or contributed to the reported issue have been considered.The reported application presents an off label use of the device.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; the ifu states: 'prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline.Flushing these lumens will also facilitate stent graft deployment.' the ifu states: 'prior to stent graft deployment, 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.' furthermore, the ifu states: 'the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.'.

Event Description

It was reported that during a stent graft placement procedure intended for an aneurysm in the iliac artery with access through the femoral artery, an increase of force was necessary to start the stent graft deployment, however, the stent allegedly failed to deploy.Reportedly.There was difficulty retracting the delivery system from the patient yet, the device was removed from the patient's body.Furthermore, it was observed that the stent had been stuck and after several attempts, the stent had deployed outside of the patient.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: FLUENCY PLUS VASCULAR 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: 7051324
• MDR Text Key: 93048038
• Report Number: 9681442-2017-00300
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145360
• UDI-Public: (01)00801741145360
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2019
• Device Catalogue Number: FVL14100
• Device Lot Number: ANAQ1566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• 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