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

Catalog Number FVL06060

Device Problems Positioning Failure (1158); Fracture (1260); Retraction Problem (1536); Misfire (2532); Positioning Problem (3009)

Patient Problems Necrosis (1971); No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(b)(4).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.

Event Description

It was reported that during a stent graft deployment procedure for treatment of a tortuous path in the left renal artery, the stent graft allegedly partially deployed from the delivery system; therefore, an attempt was made to remove the device.It was further reported that the delivery system became stuck and was unable to be removed.Reportedly, surgical intervention was required to remove the stent graft.Patient was reportedly stable at the conclusion of the procedure.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been reported for this lot number previously.Investigation summary: the stent graft delivery system was returned for evaluation.Based on sample evaluation, the reported partial stent graft deployment could be confirmed.The stent graft was found to be partially released and the outer sheath was found to be fractured and elongated.In addition a 0.035 inch guide wire was found to be stuck inside the delivery system and could not be removed during evaluation.The condition of the outer sheath indicates that a increased deployment force occurred during the attempt to deploy the stent graft; the guide wire may become stuck due to deformation of the sheath material as well as due to coagulated blood inside the guide wire lumen.Potential factors which may have caused or contributed to the reported issue have been considered.The reported indication represents an off label use of the device.Based on the investigation performed the reported partial stent graft deployment and the impossibility to deploy the stent graft were confirmed.However, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding the anatomy of the placement site the ifu states: "prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy." furthermore, the ifu states: "prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline (.) flushing these lumens will also facilitate stent graft deployment." the reported application of stent graft placement during aaa procedure represents an of label use of the device.Base on the ifu supplied with this product fluency plus vascular stent graft is indicated for use in the iliac and femoral arteries.(b)(4).

Event Description

It was reported that during a stent graft deployment procedure for treatment of a tortuous path in the left renal artery, the stent graft allegedly partially deployed from the delivery system; therefore, an attempt was made to remove the device.It was further reported that the delivery system became stuck and was unable to be removed.Finally, the whole system and guidewire were removed together.However, reportedly the left kidney would necrose.Patient was reportedly stable at the conclusion of the procedure.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6916352
• MDR Text Key: 88249565
• Report Number: 9681442-2017-00277
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: FVL06060
• Device Lot Number: ANAU3701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 01/12/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2016
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 60