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

Catalog Number FEM12060

Device Problems Positioning Failure (1158); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2015

Event Type  malfunction  

Event Description

It was reported that a stent graft allegedly would not deploy in the upper arm.It was further reported that the physician used an 8 f sheath and inserted the stent delivery system and advanced it to the target lesion without difficulty.Reportedly, the stent delivery system was retracted without difficulty and another stent was used to complete the procedure.There was no reported patient injury.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.The evaluation of the returned sample confirmed the reported failure to deploy the stent graft.A stent graft strut was found to have become stuck in the radiopaque marker band which caused the deployment failure.Potential factors which could have led or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may be associated with difficult anatomic conditions or a challenging placement site leading to increased friction and subsequent damage of the distal part of the delivery system.Also the use of a wrong sized introducer sheath may be a contributing factor to a damage of the delivery system tip and subsequent jamming of the stent graft.In this case, an introducer sheath of a smaller size than recommended in the ifu was used.Insufficient flushing of the device prior to use may be another contributing factor to increased friction and subsequent device damage.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 of the same size." also the ifu states: "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." 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: 5070026
• MDR Text Key: 26065213
• Report Number: 9681442-2015-00154
• Device Sequence Number: 1
• Product Code: PFV
• 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: Followup
• Report Date: 08/17/2015

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: 07/17/2017
• Device Catalogue Number: FEM12060
• Device Lot Number: ANYG2192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• 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