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

Catalog Number FEM08040

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  Injury  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide further patient details.

Event Description

It was reported that the endovascular stent graft was used to cover a stenosis in the femoral vein in the outflow of a leg graft as a previously placed stent graft had migrated to the outflow vein.Reportedly, difficulties were experienced during deployment of the endovascular stent graft.Subsequently, a pta balloon was used for post-dilation and the tip of the balloon caused the endovascular stent graft to move forward.An angioplasty was performed by using the same pta balloon to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

The lot 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.No sample was returned.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.Potential factors which may have caused or contributed to the reported issue have been considered.As this reported event is an isolated incident no previous investigations of similar complaints could be reviewed.The reported difficult stent graft deployment as well as the reported entrapment of the balloon tip which led to stent graft movement may be associated with a difficult patient anatomy.A manufacturing related cause has also been considered.In this case no sample and no images were provided for evaluation and therefore, no deficiency could be determined which may have led to the reported event.On the basis of the information available and as no sample was returned, 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." regarding the anatomy of the placement site the ifu states: "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: "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.".

Event Description

It was reported that the endovascular stent graft was used to cover a stenosis in the femoral vein in the outflow of a leg graft as a previously placed stent graft had migrated to the outflow vein.Reportedly, difficulties were experienced during deployment of the endovascular stent graft.Subsequently, a pta balloon was used for post-dilation and the tip of the balloon caused the endovascular stent graft to move forward.An angioplasty was performed by using the same pta balloon 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: fatma demiral ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5878282
• MDR Text Key: 52173398
• Report Number: 9681442-2016-00226
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008486
• UDI-Public: (01)04049519008486(17)190108(10)ANAN0555
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2019
• Device Catalogue Number: FEM08040
• Device Lot Number: ANAN0555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• 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: 56 YR