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

Catalog Number FVL09040

Device Problems Material Invagination (1336); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2017

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.(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 to treat an aneurysm in the right common iliac, proximal to bifurcation via an ipsilateral approach through the right common femoral, the vascular stent graft jumped during deployment as excessive force was needed to deploy the stent graft from the delivery system.Therefore, the delivery system was removed from the patient without incident.Reportedly, the tracking path was mildly calcified.In addition, the delivery system was flushed prior to use and the proximal end of the stent graft was placed in a straight section prior to deployment.Another device was used and was successfully deployed, using the overlapping technique, and completing the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: 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 the specification prior to shipment.No manufacturing anomalies or changes which may have caused or contributed to the reported event have been identified.No additional complaint has been reported for this lot number previously.Investigation summary: a stent graft delivery system was received for evaluation.The safety clip was found to be removed and missing; the 2-way stopcock was found opened and the tuohy-borst valve was found closed.The outer sheath was found to be in a good condition.The stent graft was released and not returned.The inner catheter and the pusher protruded the distal tip.The distance between the y-injection adapter and the handle was 126mm.A flushing test and a guidewire patency was successfully performed.As no images/ x-rays of the location of the implanted stent graft was provided for evaluation the result of the investigation performed was inconclusive.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 labeling supplied with 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 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 not been established.".

Event Description

It was reported that during a stent graft deployment procedure to treat an aneurysm in the right common iliac, proximal to bifurcation via an ipsilateral approach through the right common femoral, the vascular stent graft jumped during deployment as excessive force was needed to deploy the stent graft from the delivery system.Therefore, the delivery system was removed from the patient without incident.Reportedly, the tracking path was mildly calcified.In addition, the delivery system was flushed prior to use and the proximal end of the stent graft was placed in a straight section prior to deployment.An additional device was used and was successfully deployed, using the overlapping technique, and completing the procedure.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
• 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: 6858164
• MDR Text Key: 85787358
• Report Number: 9681442-2017-00264
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: FVL09040
• Device Lot Number: ANZL0461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• 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 Age: 62 YR
• Patient Weight: 65