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

Catalog Number FEM14060

Device Problems Positioning Failure (1158); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.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 patient details to date.

Event Description

It was reported that during a central subclavian stenting procedure via access through a brachiocephalic fistula, the endovascular stent graft could not be deployed.Reportedly, the y-injection adapter was pulled a few times unsuccessfully.The lesion had been pre-dilated and the tracking anatomy was slightly tortuous.The delivery system was removed without any issue and another stent graft of the same brand was used to complete the procedure successfully.There was no reported patient injury.

Manufacturer Narrative

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 all specifications prior to shipment.Based on the investigation of the returned sample it was confirmed that the stent graft could only be partially deployed.The deployment system was found in used condition and two distal stent struts were found perforating the distal catheter tip which led to increased release force, sheath fracture and which made a successful stent graft deployment impossible.No indication was found for a process related event.Previous investigations of similar complaints have been reviewed.The evaluation of the returned sample revealed that the stent graft could not be deployed because stent graft struts were perforating the outer sheath of the delivery system.This may have been associated with difficult anatomic conditions or challenging placement site leading to increased friction and subsequent damage of the outer sheath.Insufficient flushing of the device prior to use may have been another contributing factor to increased friction and subsequent damage.On the basis of the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be identified.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.¿ regarding the anatomy of the placement site the ifu states: ¿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.¿.

Event Description

It was reported that during a central subclavian stenting procedure via access through a brachiocephalic fistula, the endovascular stent graft could not be deployed.Reportedly, the y-injection adapter was pulled a few times unsuccessfully.The lesion had been pre-dilated and the tracking anatomy was slightly tortuous.The delivery system was removed without any issue and another stent graft of the same brand 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: 6050145
• MDR Text Key: 58132624
• Report Number: 9681442-2016-00270
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008691
• UDI-Public: (01)04049519008691(17)190219(10)ANAP2856
• 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: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2019
• Device Catalogue Number: FEM14060
• Device Lot Number: ANAP2856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• 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