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

Model Number FEM10120

Device Problems Difficult to Remove (1528); Misfire (2532)

Patient Problem Injury (2348)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.

Event Description

It was reported that during a stent graft placement in the cephalic vein with sheathless percutaneous access via a/v fistula the delivery system allegedly froze and the stent graft partially deployed.Reportedly, resistance was felt during the deployment attempt.It was further reported that there were difficulties retrieving the delivery system from the patient and the access site enlarged.The delivery system was removed manually and a new system was used to complete the procedure.There was no reported patient injury post procedure.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the investigation of the returned catheter sample it could be confirmed that the user could only partially deploy the stent graft.The outer sheath was found with elongation which indicated that high release force / friction was present when the user tried to release the stent graft.An indication for a process related issue could not be found.Based on information available, the investigation is closed with confirmed result.A definite root cause could not be identified.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu state: '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.', and '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.' (.) 'prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.' in regards to introducer the ifu state: 'the use of an appropriately sized introducer sheath is recommended.'.

Event Description

It was reported that during a stent graft placement in the cephalic vein with sheathless percutaneous access via a/v fistula the delivery system allegedly froze and the stent graft partially deployed.Reportedly, resistance was felt during the deployment attempt.It was further reported that there were difficulties retrieving the delivery system from the patient and the access site enlarged.The delivery system was removed manually and a new system was used to complete the procedure.There was no reported patient injury post procedure.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8937474
• MDR Text Key: 155779494
• Report Number: 2020394-2019-02981
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008622
• UDI-Public: (01)04049519008622
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: FEM10120
• Device Catalogue Number: FEM10120
• Device Lot Number: ANDR0773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention