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

Catalog Number	FEM08040
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 further procedural details.
Event or Problem Description
It was reported that the endovascular stent graft got stuck after an attempt to be deployed in an upper arm dialysis graft.Another endovascular 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.On the basis of the condition of the returned device, a deployment failure could not be confirmed as no attempt to deploy the stent graft had been made.The stent graft was found to be completely loaded in the system and the safety clip was found properly attached.The outer sheath did not show any signs of the impact of deployment force.The distal tip of the delivery system was found significantly deformed.Reportedly, a 7 f introducer sheath was used during the procedure.During the performed patency test, the delivery system got stuck inside a 7 f introducer sheath.Potential contributing factors to the reported event have been considered.Based on the evaluation results, no deployment failure could be identified but a failure to advance the device through an introducer sheath of inappropriate size could be confirmed.As this was found to be an isolated incident, no previous investigations of similar complaints could have been reviewed.As per the product labeling information, the device requires a minimum introducer sheath size of 9 f.The ifu states: "materials required for the fluency plus endovascular stent graft procedure: introducer sheath with appropriate inner diameter." the product labeling on the packaging indicates that a minimum introducer size of 9 f should be used.

• 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: 5534889
• Report Number: 9681442-2016-00092
• Device Sequence Number: 279433
• Product Code: PFV
• UDI-Device Identifier: 04049519008486
• UDI-Public: (01)04049519008486(17)180910(10)ANZI1312
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P130029/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2016

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: 09/10/2018
• Device Catalogue Number: FEM08040
• Device Lot Number: ANZI1312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2016
• Supplement Report FDA Received Date: 06/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1