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

Catalog Number FEM12100

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

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

Event Date 08/13/2015

Event Type  Injury  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.Not returned.

Event Description

It was reported that an endovascular stent graft which was deployed in an arm vein appeared to have a eptfe layer removed from the bare metal of the stent graft.An intervention was performed on a separate day to deploy a second stent within the first one to hold it open.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 all specifications prior to shipment.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample was returned.On the basis of the evaluation of the images provided, the alleged delamination of the stent graft covering could not be confirmed since the covering was not visible under x-ray.The stent strut pattern did not appear inhomogeneous and no deficiency could be identified.Potential contributing factors to the reported event have been considered.As the reported event was found to be an isolated incident, no similar investigations of previous complaints could have been reviewed.The reported event may be related to a difficult vessel anatomy or improper balloon dilation.In this case, reportedly the lesion was difficult to pre-dilate.On the information available, the reported event could not be reproduced and a definite root cause could not be determined.The ifu states: "pre-dilate the stented restenotic lumen with a balloon diameter no larger than the previously placed bare metal stent (.).Do not use the device in patients where full expansion of an appropriately sized angioplasty balloon could not be achieved during pre-dilation (.).Post-dilation of the stent graft must be performed with a pta balloon catheter no larger than the previously placed bare metal stent.The stent graft implant cannot be expanded with an angioplasty balloon beyond its stated diameter." also the ifu states: "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed.".

• 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: 5078016
• MDR Text Key: 25825795
• Report Number: 9681442-2015-00157
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2017
• Device Catalogue Number: FEM12100
• Device Lot Number: ANYG2195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 113