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

Model Number FEM10100

Device Problems Fracture (1260); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

Event Type  malfunction  

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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 at the venous anastomosis on leg graft, the stent graft was allegedly difficult to advance into the sheath.Reportedly, after the stent graft was deployed, the delivery system was difficult to remove out of the sheath.There was no reported patient injury.

Manufacturer Narrative

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 remarkable 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: based on the sample evaluation a sheath fracture could be confirmed.The stent graft was released and the outer sheath was found elongated which indicates that increased friction affected the whole system and subsequently resulted in an outer sheath fracture.However, based on event information provided and as the stent graft was not loaded inside the sheath, is considered that the stent graft was successfully placed at the target lesion.Based on patency test performed during sample evaluation, the reported difficulties to advance as well as during removal could not be reproduced.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu recommends the use of an introducer sheath with appropriate inner diameter.In this case a 9f introducer sheath was used.The ifu states: "if resistance is encountered removing the delivery system, it is recommended to remove the delivery system, introducer and guidewire as a single unit." regarding the anatomy of the placement site 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.".

Event Description

It was reported that during a stent graft deployment procedure at the venous anastomosis on leg graft, the stent graft was allegedly difficult to advance into the sheath.Reportedly, after the stent graft was deployed, the delivery system was difficult to remove out of the sheath.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; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6925829
• MDR Text Key: 89735169
• Report Number: 2020394-2017-01294
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008615
• UDI-Public: (01)04049519008615
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

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: 09/06/2020
• Device Model Number: FEM10100
• Device Catalogue Number: FEM10100
• Device Lot Number: ANBT0872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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: 70 YR
• Patient Weight: 151