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

Catalog Number FEM12040

Device Problems Positioning Failure (1158); Material Perforation (2205)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

It was reported that an endovascular stent graft could not be deployed in a left subclavian vein, therefore, the endovascular stent was exchanged over a guide wire for a new endovascular stent graft that was deployed successfully.There is no reported patient injury.New information rec'd: based on the eval of the sample returned, struts of the stent graft were found to protrude the distal tip of the delivery system.

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 / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

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 eval of the returned device confirmed the reported deployment failure.The stent graft was loaded in the system upon sample receipt.Two stent struts were found to have perforated the distal outer sheath which made stent graft deployment impossible.Potential factors that may have caused or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.A challenging placement site, a tortuous tracking anatomy, not using an introducer sheath or the use of an inappropriate guide wire may be contributing factors to a damage to the delivery system tip and subsequent perforation.Also, insufficient flushing of the device prior to use may contribute to increased friction force and subsequent device damage in this case, it is unk whether an appropriate introducer sheath was used.Based on the info available, a definite root cause cannot be determined.

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 reported deployment failure.The stent graft was loaded in the system upon sample receipt.Two stent struts were found to have perforated the distal outer sheath which made stent graft deployment impossible.Potential factors that may have caused or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.A challenging placement site, a tortuous tracking anatomy, not using an introducer sheath or the use of an inappropriate guide wire may be contributing factors to a damage to the delivery system tip and subsequent perforation.In this case, the procedure was performed sheathless.Also insufficient flushing of the device prior to use may contribute to increased friction force and subsequent device damage.Based on the information available, a definite root cause 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 that the use of an appropriately sized introducer sheath and a stiff 0.035" guide wire is recommended.Furthermore, the ifu states: "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (.).".Deleted 'in this case, it is unknown whether an appropriate introducer sheath was used.' and replaced with 'in this case, the procedure was performed sheathless.'.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: frank kirchner ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4821049
• MDR Text Key: 18031283
• Report Number: 9681442-2015-00058
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2017
• Device Catalogue Number: FEM12040
• Device Lot Number: ANYD2721
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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