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

Catalog Number FVL14120

Device Problems Fracture (1260); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or 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 not been returned to the manufacturer for evaluation to date.The investigation of the reported event is currently underway.The product catalog number identified has not been cleared in the u.S, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.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 to cover the external iliac artery, with access through the right femoral artery, and overlapping a competitor's device, the outer sheath of the stent graft allegedly fractured.Reportedly, the anatomy of the tracking vessel was severely calcified, there was difficulty advancing the delivery system to the target lesion, and there was resistance during the deployment attempt.Therefore, the device was removed out of the patient and 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 incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.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 images and no physical sample were provided for evaluation.Potential factors which may have caused or contributed to the reported issue have been considered.As a result of the investigation performed and as no sample was returned the complaint is inconclusive.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 the preparation the ifu states: "prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment." regarding the placement site 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.".

Event Description

It was reported that during a stent graft placement procedure to cover the external iliac artery, with access through the right femoral artery, and overlapping a competitor's device, the outer sheath of the stent graft allegedly fractured.Reportedly, the anatomy of the tracking vessel was severely calcified, there was difficulty advancing the delivery system to the target lesion, and there was resistance during the deployment attempt.Therefore, the device was removed out of the patient and 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: 6991031
• MDR Text Key: 91209370
• Report Number: 9681442-2017-00289
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145377
• UDI-Public: (01)00801741145377
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: FVL14120
• Device Lot Number: ANAT3232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2016
• 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
• Patient Age: 78 YR
• Patient Weight: 68