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

Catalog Number FVL10120

Device Problems Break (1069); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the two complaints, both devices returned to bd.The device history records have been reviewed and both lots met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Potential factors which may have caused or contributed to the reported issue have been considered.Therefore, previous investigations of similar complaints have been reviewed.Reportedly, the guidewire got caught after deployment, and the user alleged that the system may have damaged the guidewire coating.Guidewire friction may increase if the lumen is not properly flushed; a hydrophil coating may even lead to sticky surface if not sufficiently hydrogenated; therefore, the event may be related to insufficient flushing before use.Increased friction between guidewire and guidewire lumen may be caused by damage during transportation, storage, or unpacking.Difficult patient anatomy, challenging placement site, or force increase during deployment may be contributing factors for deformation and subsequent friction increase.In this case the stent graft could be released without issue, and the system was reportedly well flushed before use; system compatible 9f introducer and 0.035" guidewire were being used.The user considered a packaging related shape set as a potential root cause; inside packaging the product is in a bent configuration which leads to a minor shape set after extraction from the tray, however, during design verification and validation testing the packaging was successfully tested.The system getting stuck in the introducer sheath after the guide wire had been stuck was considered a subsequent event caused by deformation and friction increase.Based on the information available a definite root cause for the reported event could not be determined.(b)(4).

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model fvl10120.Vascular stent graft allegedly experienced break, difficult to remove, retraction problem and device-device incompatibility.These reports were received from various sources.Of the two events, both involved patients with no patient consequences.Age, weight, and gender were not provided for both patients.

Manufacturer Narrative

For the two complaints, both devices returned to bd.The device history records have been reviewed and both lots met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Potential factors which may have caused or contributed to the reported issue have been considered.Therefore, previous investigations of similar complaints have been reviewed.Reportedly, the guidewire got caught after deployment, and the user alleged that the system may have damaged the guidewire coating.Guidewire friction may increase if the lumen is not properly flushed; a hydrophil coating may even lead to sticky surface if not sufficiently hydrogenated; therefore, the event may be related to insufficient flushing before use.Increased friction between guidewire and guidewire lumen may be caused by damage during transportation, storage, or unpacking.Difficult patient anatomy, challenging placement site, or force increase during deployment may be contributing factors for deformation and subsequent friction increase.In this case the stent graft could be released without issue, and the system was reportedly well flushed before use; system compatible 9f introducer and 0.035" guidewire were being used.The user considered a packaging related shape set as a potential root cause; inside packaging the product is in a bent configuration which leads to a minor shape set after extraction from the tray, however, during design verification and validation testing the packaging was successfully tested.The system getting stuck in the introducer sheath after the guide wire had been stuck was considered a subsequent event caused by deformation and friction increase.Based on the information available a definite root cause for the reported event could not be determined.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model fvl10120.Vascular stent graft allegedly experienced break, difficult to remove, retraction problem and device-device incompatibility.These reports were received from various sources.Of the two events, both involved patients with no patient consequences.Age, weight, and gender were not provided for both patients.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8794794
• MDR Text Key: 151286163
• Report Number: 9681442-2019-00103
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: No Information
• Device Catalogue Number: FVL10120
• Device Lot Number: ANBU2936, ANBQ0442
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/14/2019
• Patient Sequence Number: 1