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

Catalog Number FVL09060

Device Problems Positioning Failure (1158); Misfire (2532); Malposition of Device (2616); Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The catalog number identified has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified, respectively.

Event Description

It was reported that during a stent graft deployment procedure, the stent graft allegedly was not deployed in proper position.It was further reported during repositioning the stent graft, the stent did not allegedly expand and allegedly detached within the sheath.Reportedly, the stent was removed and another stent was deployed.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.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.Investigation summary: a stent graft delivery system was returned.Based on the evaluation of the returned sample a partially deployed stent graft could be confirmed.Upon sample receipt the stent graft was found partially deployed and during evaluation testing the stent graft could not be deployed as the outer sheath elongated.A misplacement of the stent graft could not be confirmed because images have not been provided.A manufacturing related issue could not be identified.Based on the evaluation of the returned sample the investigation will be confirmed for a partially deployed stent graft.The reported application represents an off label use of the device.A definite root cause for the reported event could not be determined.Labeling review:in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment." regarding the use of accessories the ifu states: "the catheter tip is tapered to accommodate a 0.035 in.Guide wire." and "an appropriate guide wire is required before introduction of the stent graft delivery system into the body." in this case a 0.038" guide wire was used.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." holding the delivery system and stent graft deployment were found sufficiently described in the ifu.In addition, the fluency plus vascular stent graft is intended for use in the iliac and femoral arteries.The ifu states: "the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have bot been established." (device code: 1528-difficult to remove ).

Event Description

It was reported that during a stent graft deployment procedure, the stent graft allegedly was not deployed in proper position.It was further reported during repositioning the stent graft, the stent did not allegedly completely deploy and deployed in the sheath.Reportedly, the delivery system was removed and another device was used.There was no reported patient injury.

• 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
• MDR Report Key: 8043263
• MDR Text Key: 127068782
• Report Number: 9681442-2018-00196
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145162
• UDI-Public: (01)00801741145162
• 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
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

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: 08/31/2020
• Device Catalogue Number: FVL09060
• Device Lot Number: ANBV0669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60