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

Catalog Number FVM07100

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

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 placement procedure intended for the right renal artery by access through the left armpit, the sheath of the delivery system allegedly tore off.The procedure was finished by using another stent graft.There is no reported patient injury.

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 remarkable incidents occurred during the manufacturing process.No indication was found for a manufacturing related issue.No additional complaint has been previously reported for this lot number.Investigation summary: on the basis of the returned stent graft delivery system, the alleged outer sheath fracture could be confirmed.The distal tantalum markers of the stent graft were found to be released and the outer sheath was found to be elongated, which indicated that a high deployment force was present during the deployment attempt which subsequently resulted in an outer sheath fracture.The reported application presents an off label use of the device.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 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." 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 fluency plus vascular stent graft is indicated for use in the iliac and femoral arteries.

Event Description

It was reported that during a stent graft placement procedure intended for the right renal artery by access through the left armpit, the sheath of the delivery system allegedly tore off.The procedure was finished by using another stent graft.There is no reported patient injury.

Manufacturer Narrative

The previously submitted emdr inaccurately reported the date.The date should have been reported as (b)(6) 2017.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 remarkable incidents occurred during the manufacturing process.No indication was found for a manufacturing related issue.No additional complaint has been previously reported for this lot number.Investigation summary: on the basis of the returned stent graft delivery system, the alleged outer sheath fracture could be confirmed.The distal tantalum markers of the stent graft were found to be released and the outer sheath was found to be elongated, which indicated that a high deployment force was present during the deployment attempt which subsequently resulted in an outer sheath fracture.The reported application presents an off label use of the device.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 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." 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 fluency plus vascular stent graft is indicated for use in the iliac and femoral arteries.

Event Description

It was reported that during a stent graft placement procedure intended for the right renal artery by access through the left armpit, the sheath of the delivery system allegedly tore off.The procedure was finished by using another stent graft.There is 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: 6899208
• MDR Text Key: 87630019
• Report Number: 9681442-2017-00272
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: FVM07100
• Device Lot Number: ANBT0227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• 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