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

Catalog Number FEM14060

Device Problems Break (1069); Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.

Event Description

It was reported that during a sheathless stenting procedure of the innominate vein, after deployment of the endovascular stent graft it was noticed that the distal stent end had not expanded.In an effort to open the distal stent end, the delivery system catheter was advanced through the stent, which was successful.Upon removal, the radiopaque marker was found to be detached from the delivery system and floating over the guide wire.A snare was used to retrieve the guide wire with the radiopaque marker as a single unite.As reported, there was no harm to the patient and the result of the stent placement procedure was satisfactorily.No patient injury was reported.

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.The evaluation of the returned device confirmed the breakage of the distal tip of the outer sheath including the radiopaque marker band.The condition of the sample indicates that increased friction must have affected on the delivery system during stent graft deployment as the system was found to be bent and kinked.The outer sheath was found to be elongated indicating the presence of increased resistance during stent graft deployment.As no images of the implanted stent graft were provided, the reported failure to fully expand the stent graft could not be confirmed.Potential contributing factors to the event reported have been evaluated.Previous investigations of similar complaints have been reviewed.A challenging placement site or tortuous tracking anatomy may be contributing factors to the reported event.Also not using an introducer sheath may contribute to a damage to the tip of the delivery system and subsequent breakage.In this case, no introducer sheath was used during the procedure.Insufficient flushing of the device may be another contributing factor to increased friction and subsequent device damage.Reportedly, high force was required during stent graft deployment and one end of the stent graft was found not completely expanded after deployment but could be opened finally.On the basis of the information available, 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." and "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".Also the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion." the ifu indicates that the use of an appropriately sized introducer sheath is recommended and that the device must be flushed with sterile saline.

• 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: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5700828
• MDR Text Key: 46608337
• Report Number: 9681442-2016-00151
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008691
• UDI-Public: (01)04049519008691(17)190129(10)ANAN3569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029/S001
• 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: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2019
• Device Catalogue Number: FEM14060
• Device Lot Number: ANAN3569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 58