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

Catalog Number FEM14120

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that during placement of the endovascular stent graft in overlapping technique for treatment of a brachiocephalic fistula, the stent graft could not be deployed any further after being released 2 cm and the shaft of the delivery system broke.The entire device was retracted and another stent graft was used to complete the procedure successfully.No patient injury was reported.

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 or unwilling to provide any patient or procedural details to date.

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.There is no indication for a manufacturing-related failure.The evaluation of the returned sample confirmed the event information received.The stent graft was found to be partially deployed and the outer sheath was found to be torn off and elongated distal to the handle.The condition of the sample indicates that increased friction affected the delivery system during the attempt to deploy the stent graft and finally resulted in an outer sheath fracture.No indication was found that a manufacturing related issue may have caused the reported problem.Potential contributing factors to the reported event 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 and subsequent sheath fracture.Furthermore, the delivery system catheter should be held in a straight position without slack.A not correctly held delivery system could be a contributing factor for the reported event.In this case it was reported that there was a 90 degree bend in the catheter part outside the patient during the attempt to deploy the stent graft.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.The ifu states "ensure slack is removed from the endovascular system" and "ensure the delivery catheter is straight (.)" in this case it was reported that there was a 90 degree bend in the stent shaft outside the sheath during deployment.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" and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." furthermore, 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" and "precautions: the device has not been tested for use in an overlapped condition with another fluency plus stent graft." 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.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 4902405
• MDR Text Key: 6018038
• Report Number: 9681442-2015-00095
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2017
• Device Catalogue Number: FEM14120
• Device Lot Number: ANYI0821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• 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