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

Catalog Number FVM14120

Device Problems Positioning Failure (1158); Fracture (1260); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2017

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 product 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.

Event Description

It was reported that the vascular stent allegedly partially deployed; therefore, a second device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

New information provided revealed that the reported date of awareness was incorrect.The event information was reported to the dealer/distributor (a non-bard entity) on (b)(6) 2017; however, the dealer/distributor did not report the event to a bard employee until (b)(6) 2017.Therefore, the date of awareness and the emdr date of awareness were updated to (b)(6) 2017.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.The review showed that no remarkable incidents occurred during the manufacturing process.No additional complaint has been reported for this lot number previously investigation summary: on the basis of the returned stent graft delivery system, the alleged deployment failure could be confirmed.The stent graft was found to be partially released.The outer sheath was found to be elongated over the entire length, which indicated that a high deployment force was present during the deployment attempt which subsequently resulted in an outer sheath fracture.As a result of the investigation performed the complaint was confirmed.Based on the available information and the evaluation of the returned sample, 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 and the patient anatomy 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." and "predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician." 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: "the sterile packaging and devices should be inspected prior to use.Verify that the packaging and the device are undamaged and that the sterile barrier is intact.If damaged, do not use.".

Event Description

It was reported that a vascular stent allegedly partially deployed so, a second device was used and this device also partially deployed.Therefore, a third device was used in order to complete the procedure.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 the specification prior to shipment.The review showed that no remarkable incidents occurred during the manufacturing process.No additional complaint has been reported for this lot number previously on the basis of the returned stent graft delivery system, the alleged deployment failure could be confirmed.The stent graft was found to be partially released.The outer sheath was found to be elongated over the entire length, which indicated that a high deployment force was present during the deployment attempt which subsequently resulted in an outer sheath fracture.As a result of the investigation performed the complaint was confirmed.Based on the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.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 and the patient anatomy 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." and "predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician." 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: "the sterile packaging and devices should be inspected prior to use.Verify that the packaging and the device are undamaged and that the sterile barrier is intact.If damaged, do not use." (date of awareness changed on new information received: (b)(6) 2017).

Event Description

It was reported that a vascular stent allegedly partially deployed so, a second device was used and this device also partially deployed.Therefore, a third device was used in order to complete 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: 6885046
• MDR Text Key: 88230322
• Report Number: 9681442-2017-00269
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: FVM14120
• Device Lot Number: ANZK3854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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