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

Catalog Number FEL10080

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); 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.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 or further procedural details.

Event Description

It was reported that the sheath of the endovascular stent graft delivery system broke during deployment.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.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample or image was provided for evaluation.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This type of event may be associated with a difficult vessel anatomy leading to increased friction and subsequent sheath fracture.In this case, no information regarding the anatomy of the tracking vessel and the target site was provided.Insufficient flushing of the device might be another contributing factor.It is unknown whether the system had been flushed prior to use.On the basis of the information available and as no sample was returned, a definite root cause for the reported event could not be determined.The ifu states that the device must be flushed with sterile saline.Also 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." furthermore, 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.".

• 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: 5700829
• MDR Text Key: 47852990
• Report Number: 9681442-2016-00152
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008257
• UDI-Public: (01)04049519008257(17)180723(10)ANZG2606
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

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: 07/23/2018
• Device Catalogue Number: FEL10080
• Device Lot Number: ANZG2606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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