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

Model Number FEM12040

Device Problems Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2017

Event Type  malfunction  

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 Description

It was reported that during treatment of a de novo lesion in a fistula in the cephalic arch, resistance was felt during insertion of the endovascular stent graft delivery system.The access was gained in a right upper arm brachiocephalic fistula.The delivery system was removed and the distal tip was allegedly found to be deformed.Another device was used to finish the procedure successfully.There was no reported patient injury.

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 device, the reported deformation of the distal tip of the delivery system could be confirmed.The tip of the inner catheter was found to be invaginated, however, during the performed patency test a device compatible guide wire could be advanced through the entire system.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.In this case, the tip of the inner catheter was found to be invaginated.This may have occurred during advancement of the delivery system over a guide wire as well as during the attempt to insert the device into the patient without using an introducer sheath.Also insufficient flushing of the device may result in increased friction and subsequent invagination.Reportedly, no introducer sheath was used during the procedure.On the basis of the information available and the evaluation of the returned device, 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 that prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline.In addition, the ifu indicates that a 0.035" (0.89 mm) guide wire as well as an introducer sheath of appropriate inner diameter are required for the procedure.The reported application represents an off-label use of the device.The ifu states that the fluency plus endovascular stent graft is indicated for use in the treatment of in-stent restenosis and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an av graft.

Event Description

It was reported that during treatment of a de novo lesion in a fistula in the cephalic arch, resistance was felt during insertion of the endovascular stent graft delivery system.The access was gained in a right upper arm brachiocephalic fistula.The delivery system was removed and the distal tip was allegedly found to be deformed.Another device was used to finish the procedure successfully.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstr. 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6618252
• MDR Text Key: 76862458
• Report Number: 9681442-2017-00191
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008639
• UDI-Public: (01)04049519008639(17)191223(10)ANAZ3527
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2019
• Device Model Number: FEM12040
• Device Catalogue Number: FEM12040
• Device Lot Number: ANAZ3527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1