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

Catalog Number FEM08080

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Difficult to Remove (1528); Stretched (1601); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during placement of the endovascular stent graft in the cephalic vein via access through a left upper arm a/v graft for treatment of a reoccurring lesion with a 30 % residual stenosis after balloon dilation, the stent graft could not be deployed.Reportedly, the anatomy of the tracking vessel was tortuous and the proximal end of the stent graft was placed in a corner.During retraction of the delivery system, difficulties occurred and the shaft appeared to be stretching.Reportedly, the entire system was removed.No other stent was placed this day.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.There is no indication for a manufacturing-related failure.The condition of the returned device confirmed the reported deployment difficulties.The outer sheath was found to be elongated which indicates that increased friction must have affected on the delivery system during the attempt to release the stent graft.Reportedly, the stent graft could be successfully implanted after the initial deployment failure and was not returned.The reported difficulties in removing the delivery system could not be reproduced.Except for the elongation of the outer sheath, the delivery system was found to be in good condition and a patency test with a device compatible 0.035"' guide wire could be performed successfully.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The event may be associated with difficult anatomic conditions leading to increased friction during deployment.Reportedly, the anatomy of the tracking vessel was tortuous and the proximal end of the stent graft was placed in a corner.Insufficient flushing of the device may be another contributing factor 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: "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." the ifu indicates that the device must be flushed with sterile saline.

• 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: 5665291
• MDR Text Key: 45473201
• Report Number: 9681442-2016-00134
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008509
• UDI-Public: (01)04049519008509(17)180723(10)ANZG2625
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029/S002
• 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: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2018
• Device Catalogue Number: FEM08080
• Device Lot Number: ANZG2625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 64