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

Catalog Number FVL10060

Device Problems Misfire (2532); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.

Event Description

It was reported that during treatment for an abdominal aneurysm through a femoral artery approach the stent graft allegedly partially deployed 2cm.Therefore, the delivery system was removed from the patient without incident.It was further alleged the delivery system was checked outside of the patient and two kinks were identified in the shaft.Reportedly, another delivery system was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: no physical sample and no images were returned.Therefore, the reported failure could not be reproduced and the investigation will be closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that 'prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' regarding the anatomy of the placement site the ifu states: 'prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus vascular stent graft products are identified in d2 and g5.

Event Description

It was reported that during treatment for an abdominal aneurysm through a femoral artery approach the stent graft allegedly partially deployed 2cm in the iliac artery.Therefore, the delivery system was removed from the patient without incident.It was further alleged the delivery system was checked outside of the patient and two kinks were identified in the shaft.Reportedly, another delivery system was used to complete the procedure.There was no reported patient injury.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8269041
• MDR Text Key: 133846432
• Report Number: 9681442-2018-00240
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145223
• UDI-Public: (01)00801741145223
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

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: 07/31/2020
• Device Catalogue Number: FVL10060
• Device Lot Number: ANBU2369
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 55