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

Catalog Number FEM10120

Device Problems Positioning Failure (1158); Fracture (1260); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

As the lot number of the subject device has not been provided, a device history record review could not be performed to date.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient, product, or procedural details.

Event Description

It was reported that the endovascular stent graft failed to deploy in the basilic vein via access through a forearm graft due to the separation of the shaft of the delivery system.The device was removed from the patient without any issues.Another device was used to complete the procedure successfully.There was no reported patient injury.

Manufacturer Narrative

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 all specifications prior to shipment.On the basis of the evaluation of the returned delivery system it could be confirmed that the stent graft could not be deployed and that the outer sheath was fractured.No indication was found for manufacturing related issues.Potential factors which may have contributed to the reported issue have been considered.Previous investigations of similar complaints have been reviewed.The event may have been associated with difficult anatomic conditions, which led to increased friction during deployment.Also, insufficient flushing of the device could be another contributing factor for the event.As reported no introducer sheath was used, which could be also a potential contributing factor.Based on the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.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 of the same size.¿ and ¿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.¿ furthermore, the ifu states: ¿do not kink the delivery catheter or use excessive force during delivery to the target lesion.¿ and ¿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.¿ additionally, the ifu states that the materials required for the fluency plus endovascular stent graft procedure are ¿(.) introducer sheath with appropriate inner diameter (.)¿.

Event Description

It was reported that the endovascular stent graft failed to deploy in the basilic vein via access through a forearm graft due to the separation of the shaft of the delivery system.The device was removed from the patient without any issues.Another device was used to complete the procedure successfully.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 -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: fatma demiral ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5784832
• MDR Text Key: 49290616
• Report Number: 9681442-2016-00198
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

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: 07/17/2017
• Device Catalogue Number: FEM10120
• Device Lot Number: ANZG1824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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