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

Model Number	FEM14120
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2017
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 further patient or procedural details to bard.
Event or Problem Description
It was reported that the endovascular stent graft could not be deployed in the left upper arm and that excessive force was used in an unsuccessful attempt to deploy the stent graft resulting in the fracture of the outer catheter.There was no reported difficulty in retracting the delivery system from the patient.Another device was used for successful completion of the procedure.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.On the basis of the evaluation of the returned delivery system, the reported event could be confirmed.The stent graft was found to be completely loaded in the system upon sample receipt.The outer sheath was found to be heavily elongated and fractured indicating that increased friction must have affected on the delivery system during the attempt to deploy the stent graft.The fracture of the outer sheath made a successful stent graft release impossible.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may be associated with a difficult vessel anatomy leading to increased friction and subsequent sheath fracture.Insufficient flushing of the device may be another contributing factor to the reported event.On the basis of the information available and the evaluation of the sample, 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." furthermore, the ifu indicates that an introducer sheath with appropriate inner diameter is required for the procedure.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 in the left upper arm and that excessive force was used in an unsuccessful attempt to deploy the stent graft resulting in the fracture of the outer catheter.There was no reported difficulty in retracting the delivery system from the patient.Another device was used for successful completion of the procedure.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; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6559626
• Report Number: 9681442-2017-00174
• Device Sequence Number: 18852487
• Product Code: PFV
• UDI-Device Identifier: 04049519008721
• UDI-Public: (01)04049519008721(17)190324(10)ANAQ3433
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 07/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2019
• Device Model Number: FEM14120
• Device Catalogue Number: FEM14120
• Device Lot Number: ANAQ3433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR