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

Catalog Number FEM12040

Device Problem Positioning Failure (1158)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the endovascular stent graft could not be deployed in an a/v fistula.Another stent was used to complete the procedure successfully.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 revealed that the stent graft was still loaded in the delivery system.The outer sheath was found to be perforated by a stent graft strut making stent graft deployment impossible.Potential contributing factors 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 which can lead to increased friction and subsequent damage to the outer sheath.Not using an introducer sheath or the use of an inappropriate guide wire also may contribute to a damage of the delivery system tip and subsequent perforation.In this case, no introducer sheath was used.Insufficient flushing of the device may be another contributing factor.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: "the safety and effectiveness of the device when placed across a tight bend including the terminal cephalic arch or across the elbow joint 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." furthermore, the ifu states that a 0.035" (0.89 mm) guide wire as well as an introducer sheath with appropriate inner diameter are required for the procedure and that the device must be flushed.Furthermore, the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion.".

• 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: 5260074
• MDR Text Key: 32781071
• Report Number: 9681442-2015-00237
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008639
• UDI-Public: (01)04049519008639(17)170717(10)ANYG2189
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029/S003
• 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: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• 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: FEM12040
• Device Lot Number: ANYG2189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2016
• 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
• Patient Age: 55 YR
• Patient Weight: 65