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

Catalog Number	FEM07100
Medical Device Problem Codes	Material Invagination (1336); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem Description
It was reported that the endovascular stent graft should be placed in the upper arm during a fistulogram procedure.During sheathless insertion of the stent delivery system, resistance was felt and the device could not be advanced over the guide wire to the lesion site through the tracking anatomy.Another stent graft of the same brand 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.During the evaluation of the returned delivery system, the distal tip was found to be invaginated; may be as a consequence of the reported difficulties in inserting the device into the patient's body.During the performed patency test, a device compatible 0.035" guide wire could be inserted into and advanced through the delivery system without issue.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This type of event may be associated with insufficient flushing of the device.Not using an introducer sheath may be another contributing factor to the reported insertion difficulties finally resulting in the deformation of the tip.In this case, no introducer sheath was used.Rough handling of the device during unpacking or preparation also may contribute 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: "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." also the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline." furthermore, the ifu indicates that an introducer sheath of appropriate inner diameter is required for the procedure.Updated 'eval code & desc - conclusion' due to completion of evaluation.
Event or Problem Description
It was reported that the endovascular stent graft should be placed in the upper arm during a fistulogram procedure.During sheathless insertion of the stent delivery system, resistance was felt and the device could not be advanced over the guide wire to the lesion site through the tracking anatomy.Another stent graft of the same brand was used to complete the procedure successfully.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: 6311862
• Report Number: 9681442-2017-00049
• Device Sequence Number: 16538238
• Product Code: PFV
• UDI-Device Identifier: 04049519008462
• UDI-Public: (01)04049519008462(17)190513(10)ANAS1266
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/03/2017

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: 05/13/2019
• Device Catalogue Number: FEM07100
• Device Lot Number: ANAS1266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 101