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

Catalog Number	FEL07080
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional 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 any patient or procedural details to date.
Event or Problem Description
It was reported that the endovascular stent graft could not be deployed.There was no reported patient injury.
Additional 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.For this reason, the reported event could not be reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This kind of event may be related to a difficult vessel anatomy or challenging stent placement site.Insufficient flushing of the device may be another contributing factor to increased release force.The use of inappropriate accessories also may contribute to this type of event.Reportedly, the lesion had been pre-dilated but the vessel was resistant to pta.On the basis of the information available and as no sample was returned for evaluation, a definite root cause for the reported event could not be determined.The ifu states that the device must be flushed with sterile saline.Also 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." and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." in addition, 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.".
Event or Problem Description
It was reported that the endovascular stent graft could not be deployed inside an a/v graft in the basilic vein.The device was removed and another stent graft was used for treatment.Reportedly, the lesion had been pre-dilated but the vessel was resistant to pta.There was no reported patient injury.
Additional 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 device confirmed the active use of the deployment mechanism and the partial release of the stent graft.The delivery system was found to be contaminated with coagulated blood.Due to these blood residues, flushing and stent release testing could not be performed successfully during sample evaluation.Increased friction is considered the reason for increased release force and subsequent deployment failure.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.Increased friction and subsequent deployment failure may be related to a difficult vessel anatomy or challenging stent placement site.Insufficient flushing of the device may be another contributing factor to increased release force.Reportedly, the lesion had been pre-dilated but the vessel was resistant to pta.On the basis of the information available and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.The ifu indicates that the device must be flushed with sterile saline.Also 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." and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." in addition, 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.".
Event or Problem Description
It was reported that the endovascular stent graft could not be deployed inside an a/v graft in the basilic vein.The device was removed and another stent graft was used for treatment.Reportedly, the lesion had been pre-dilated but the vessel was resistant to pta.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 5980135
• Report Number: 9681442-2016-00251
• Device Sequence Number: 18975107
• Product Code: PFV
• UDI-Device Identifier: 04049519008103
• UDI-Public: (01)04049519008103(17)190129(10)ANAN3496
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2019
• Device Catalogue Number: FEL07080
• Device Lot Number: ANAN3496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 10/19/2016; 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 88