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

Catalog Number FEM08060

Device Problems Break (1069); Difficult to Advance (2920); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a sheathless stenting procedure for treatment of a pre-dilated stenosis of the left antecubital area in the forearm near an arterial anastomosis via access through the brachial artery, the stent delivery system was difficult to insert through the access site.Upon withdrawal of the system after stent graft placement, a piece of the delivery system was allegedly left hanging out of the hole in the arm.The delivery system was removed without any issues.As reported, the distal end of the stent graft did not fully expand upon post-dilation; however, as this was only 1 mm or less there was no need for any further treatment and the procedure was completed.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 evaluation of the returned delivery system confirmed the breakage of the inner catheter.All parts of the device could be removed from the patient.The reported insertion difficulties could not be reproduced; no defect of the distal tip of the outer sheath leading to the reported difficulty could be identified.On the basis of the images provided, it could be confirmed that the distal end of the implanted stent graft was marginally less expanded than the proximal part, however, the blood flow through the stent graft was good.As reported, no further treatment was necessary.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported insertion difficulties and subsequent inner catheter breakage may be associated with not using an introducer sheath, as reported by the customer.The reported failure to expand as well as the difficult advancement and inner catheter breakage also may be associated with a challenging stent placement site.In this case, it was reported that the tracking path was not tortuous or calcified and the proximal end of the stent graft was placed in a straight section of the lumen prior to stent graft deployment.Furthermore, pre- and post-dilation was performed.In this case, the failure of an incomplete stent graft expansion did not have any clinical influence and no further treatment was necessary.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be determined.The ifu states that an introducer sheath of appropriate inner diameter is required for the procedure.Furthermore, the ifu states: "after removing the delivery system, visually confirm that the complete system has been removed.Inner catheter with distal flared end.".

Event Description

It was reported that during a sheathless stenting procedure for treatment of a pre-dilated stenosis of the left antecubital area in the forearm near an arterial anastomosis via access through the brachial artery, the stent delivery system was difficult to insert through the access site.Upon withdrawal of the system after stent graft placement, a piece of the delivery system was allegedly left hanging out of the hole in the arm.The delivery system was removed without any issues.As reported, the distal end of the stent graft did not fully expand upon post-dilation; however, as this was only 1 mm or less there was no need for any further treatment and the procedure was completed.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: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6406706
• MDR Text Key: 70093619
• Report Number: 9681442-2017-00108
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008493
• UDI-Public: (01)04049519008493(17)190722(10)ANAU2983
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2019
• Device Catalogue Number: FEM08060
• Device Lot Number: ANAU2983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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
• Patient Age: 54 YR
• Patient Weight: 84