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

Catalog Number FEM09040

Device Problem Migration or Expulsion of Device (1395)

Patient Problems No Consequences Or Impact To Patient (2199); Vascular System (Circulation), Impaired (2572)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the stent graft migrated into the axilliary vein resulting in a second stent graft deployment in an overlapping manner to prevent further movement.Another stent graft was placed into the venous anastomosis to complete the procedure.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.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 or image was provided for evaluation.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.This type of event may be associated with a difficult vessel anatomy leading to an inaccurate stent graft deployment and subsequent migration.The use of a stent graft of inappropriate diameter may be another contributing factor to the reported event.In this case, no information regarding the vessel anatomy was provided.Also a too fast stent graft deployment may cause insufficient wall apposition and subsequent stent graft migration.On the basis of the limited information provided and as no sample or imgage was provided for evaluation, a definitive root cause for the reported event could not be determined.The ifu states: "careful attention of the operator is warranted to mitigate the possibility of distal (central venous system) migration of the stent graft during deployment.After deployment of approximately 15 mm of the stent graft, wait for the distal end the stent graft to fully expand." and "special care must be taken to ensure that the appropriate size fluency plus endovascular stent graft is selected prior to introduction.In order to ensure sufficient wall apposition, it is recommended to oversize the stent graft relative to the healthy (non-diseased) portion of the vessel." also the ifu states "careful attention should be paid to ensure the device is appropriately sized to the achievable lumen, taking into account any change to the stated treatment area diameter that may have resulted from previous interventions.Under-sizing the device may result in device migration." and "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.".

Event Description

It was reported that the stent graft migrated into the axilliary vein resulting in a second stent graft deployment in an overlapping manner to prevent further movement.Another stent graft was placed into the venous anastomosis to complete the procedure.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: 6221054
• MDR Text Key: 63802075
• Report Number: 9681442-2017-00002
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008530
• UDI-Public: (01)04049519008530(17)190708(10)ANAU1246
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2019
• Device Catalogue Number: FEM09040
• Device Lot Number: ANAU1246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 95