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

Catalog Number FEL14060

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2016

Event Type  Injury  

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 details.

Event Description

It was reported that during a sheathless stent placement procedure for treatment of a stenosis in the left subclavian vein via access through the cephalic vein, the radiopaque marker of the stent delivery system became detached.Reportedly, the radiopaque marker pinched the stent graft closed on the distal end.A snare device was unsuccessfully used to capture and retrieve the marker.A second stent graft was deployed to fix the radiopaque marker against the vessel wall.There was no reported patient injury.

Manufacturer Narrative

The lot 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 on the basis of the condition of the delivery system returned it could be confirmed that the radiopaque marker band detached from the distal tip of the outer sheath.Furthermore, the condition of the sample returned leads to conclude that increased friction affected the delivery system during stent graft deployment as the outer sheath of the system was found to be elongated and separated.Furthermore, based on the images provided the constriction of the stent graft by the detached radiopaque maker band could be confirmed.Potential factors that could have led or contributed to the event reported have been evaluated.Previous investigations of similar complaints have been reviewed.A difficult or challenging placement site or tortuous tracking anatomy may be contributing factors to the reported event.However, the proximal end of the stent graft was placed in a not exactly straight section of the lumen prior to stent graft deployment.Not using an introducer sheath could be a contributing factor for a tip damage and subsequent marker band detachment.In this case, no introducer was used.The sample evaluation revealed a damaged tip but based on the condition of the stent it could not be reproduced when this damage occurred exactly during the procedure.On the basis of the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.The ifu states: "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." furthermore, the ifu states: "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.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" and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." regarding the use of accessories the ifu states that the use of an appropriately sized introducer sheath is recommended and that prior to loading the endovascular system over a guide wire, both ports must be flushed (.); flushing these lumens will also facilitate stent graft deployment.

Event Description

It was reported that during a sheathless stent placement procedure for treatment of a stenosis in the left subclavian vein via access through the cephalic vein, the radiopaque marker of the stent delivery system became detached.Reportedly, the radiopaque marker pinched the stent graft closed on the distal end.A snare device was unsuccessfully used to capture and retrieve the marker.A second stent graft was deployed to fix the radiopaque marker against the vessel wall.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; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: fatma demiral ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5767932
• MDR Text Key: 48714923
• Report Number: 9681442-2016-00179
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008349
• UDI-Public: (01)04049519008349(17)180723(10)ANZG2608
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2018
• Device Catalogue Number: FEL14060
• Device Lot Number: ANZG2608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• 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
• Patient Outcome(s): Disability