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

Catalog Number	FEM08060
Medical Device Problem Codes	Fracture (1260); Material Perforation (2205)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The investigation is currently ongoing.
Event or Problem Description
It was reported that during placement of the endovascular stent graft in the basilic vein, the outer catheter of the delivery system broke and the stent graft could not be deployed.The device was retracted without issue and another stent graft was used to complete the procedure successfully.There was no reported patient injury.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 that the stent graft could not be fully deployed.A strut of the stent graft was found breaking through the tip which led to increased release force and subsequent outer sheath elongation and fracture.The stent graft was found to be partially deployed 1 mm but not flowered.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The evaluation of the returned device showed that the stent graft could not be deployed due to a stent strut perforating the distal outer sheath of the delivery system.This may be associated with difficult anatomic conditions or a challenging placement site leading to increased friction and subsequent deployment difficulties.Not using an introducer sheath may be another contributing factor to tip damage and subsequent perforation.Insufficient flushing of the device also may contribute to increased friction and subsequent device damage.In this case, no introducer sheath was used during the procedure.On the basis of the information available, 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." and "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." also the ifu states that an introducer sheath with appropriate inner diameter is required for the procedure and that the device must be flushed with sterile saline.Furthermore, the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion.".

• 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: 5703532
• Report Number: 9681442-2016-00154
• Device Sequence Number: 10918198
• Product Code: PFV
• UDI-Device Identifier: 04049519008493
• UDI-Public: (01)04049519008493(17)190205(10)ANAP0851
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130029/S001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2016

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: 02/05/2019
• Device Catalogue Number: FEM08060
• Device Lot Number: ANAP0851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 07/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 102