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

Catalog Number FEM08080

Device Problems Positioning Failure (1158); Device Difficult to Setup or Prepare (1487); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.

Event Description

It was reported that the delivery system was difficult to load onto the guide wire.After being advanced to the treatment site in the arterial limb of a forearm loop graft, the endovascular stent graft could not be deployed.The device was retracted without issue and another stent was used to complete the procedure successfully.No patient injury was reported.

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 the specification prior to shipment.There is no indication for a manufacturing-related failure.Based on the sample evaluation, the reported failure to deploy the stent graft could be confirmed.The condition of the device indicates that increased friction must have affected on the delivery system during the attempt to deploy the stent graft.A patency test with a device compatible guide wire could be performed successfully.Potential contributing factors have been considered.Previous investigations of similar complaints have been reviewed.This type of event may be associated with a difficult patient anatomy leading to increased friction.A damaged or wrong sized guide wire as well as insufficient flushing of the device also may be contributing factors to the reported event.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline." the ifu recommends the use of a 0.035" guide wire.Also the ifu states: "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated." 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." the reported application represents an off-label use of the device.As per ifu, the product is indicated for treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft.

• 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: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5006635
• MDR Text Key: 24440842
• Report Number: 9681442-2015-00125
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2017
• Device Catalogue Number: FEM08080
• Device Lot Number: ANYJ1342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2014
• 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
• Patient Age: 87 YR
• Patient Weight: 53