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

Catalog Number FVM10080

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

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 product catalog number identified 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 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, the outer sheath of the delivery system allegedly fractured from the proximal end, outside the patient.It was further reported that the stent was unable to be deployed.There was no patient injury.

Manufacturer Narrative

Manufacturing review: 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.The review showed that no remarkable incidents occurred during the manufacturing process.No additional complaints have been previously reported for this lot number.Investigation summary: 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 complaint was closed with inconclusive results.Based on the available information and as no sample was returned, a definite root cause for the reported event could not be determined.Labeling review: 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 vascular 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: "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.".

Event Description

It was reported that during a stent graft deployment procedure, the outer sheath of the delivery system allegedly fractured from the proximal end, outside the patient.It was further reported that the stent was unable to be deployed.There was no patient injury.

Manufacturer Narrative

Manufacturing review: 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.The review showed that no remarkable incidents occurred during the manufacturing process.No additional complaints have been previously reported for this lot number.The catalog number identified has not been cleared in the u.S.But, it is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510k number and pro code for the fluency plus endovascular stent graft products are identified respectively.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the user could not deploy the stent graft.The outer sheath was found elongated and fractured which indicated that excessive release force was present when the user unsuccessfully tried to release the stent.An indication for a process related issue could not be found.Therefore, based on information available the investigation of the reported issue was closed with confirmed result.However, a definite root cause for the reported event could not be determined.Labeling review: 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 vascular 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: "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." (b)(4).

Event Description

It was reported that during a stent graft deployment procedure, the outer sheath of the delivery system allegedly fractured from the proximal end, outside the patient.It was further reported that the stent was unable to be deployed.There was no 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6885047
• MDR Text Key: 87875947
• Report Number: 9681442-2017-00271
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2020

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: 04/30/2020
• Device Catalogue Number: FVM10080
• Device Lot Number: ANBR4003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 11/03/2017; 03/10/2020
• Supplement Dates FDA Received: 11/10/2017; 03/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2017
• 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