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

Catalog Number FEL10080

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.The information provided represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient details.

Event Description

It was reported that the endovascular stent graft could not be deployed during the stenting procedure.The delivery system was removed from the patient and an angioplasty was performed because no other stent was available at hospital.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.The evaluation of the returned device confirmed the reported event.The stent graft was found to be released upon sample receipt but was not returned; the disposition is unknown.No deficiency of the returned device was found which may have led to the reported failure to deploy the stent graft.For this reason, the reported event could not reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This kind of event may be related to a difficult vessel anatomy or challenging placement site.In this case, no information regarding the vessel anatomy was provided.Insufficient flushing of the device may be another contributing factor to the reported event.On the basis of the information available, 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." evaluation was completed.

Event Description

It was reported that during deployment, the endovascular stent graft allegedly would not disengage from the catheter.Reportedly, the device was removed from the patient without any issues and the procedure was completed by performing an angioplasty using a pta balloon.Allegedly, a stent placement was not necessary anymore.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.During the evaluation of the returned device, the reported event could not be confirmed.The stent graft was found to be released upon sample receipt but not returned; the disposition is unknown.No deficiency of the returned device was found which may have led to the reported failure to deploy the stent graft.For this reason, the reported event could not reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This kind of event may be related to a difficult vessel anatomy or challenging placement site.In this case, no information regarding the vessel anatomy was provided.Insufficient flushing of the device may be another contributing factor to the reported event.On the basis of the information available, 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.".

Event Description

It was reported that during deployment, the endovascular stent graft allegedly would not disengage from the catheter.Reportedly, the device was removed from the patient without any issues and the procedure was completed by performing an angioplasty using a pta balloon.Allegedly, a stent placement was not necessary anymore.There was no reported patient injury.

• 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: 5856552
• MDR Text Key: 51475771
• Report Number: 9681442-2016-00218
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008257
• UDI-Public: (01)04049519008257(17)181113(10)ANZK1499
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2018
• Device Catalogue Number: FEL10080
• Device Lot Number: ANZK1499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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