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

Catalog Number FVL06080

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure to treat an occlusion in the iliac artery, the stent allegedly failed to deploy.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

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.Manufacturing review: the lot history record of this lot was 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.Investigation summary: the sample was returned to the manufacturer for evaluation.Based on the photos provided and analysis of the returned sample, the stent graft was still loaded in the sheath and the delivery catheter was fractured.The fractured outer sheath indicated high release force was used.Therefore, the investigation is confirmed for the reported fracture and identified failure to deploy issues.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use 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.Continue until saline drips from the distal end of the delivery system".Regarding the anatomy of the placement site the instructions for use 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".Regarding accessories the instructions for use states: "a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure; the packaging pictograms indicate an introducer size of 8f and a 0.035" guidewire.Predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician'.(expiry date: 09/2022).

Manufacturer Narrative

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.Manufacturing review: the lot history record of this lot was 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.Investigation summary: the sample was returned to the manufacturer for evaluation.Based on the photos provided and analysis of the returned sample, the stent graft was still loaded in the sheath and the delivery catheter was fractured.The fractured outer sheath indicated high release force was used.Therefore, the investigation is confirmed for the reported fracture and identified failure to deploy issues.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use 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.Continue until saline drips from the distal end of the delivery system".Regarding the anatomy of the placement site the instructions for use 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".Regarding accessories the instructions for use states: "a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure; the packaging pictograms indicate an introducer size of 8f and a 0.035" guidewire.Predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician'.(expiry date: 09/2022).

Event Description

It was reported that during a stent placement procedure to treat an occlusion in the iliac artery, the stent allegedly failed to deploy.It was further reported that another device was used 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; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13576903
• MDR Text Key: 286146566
• Report Number: 9681442-2022-00043
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741144974
• UDI-Public: (01)00801741144974
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2022

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 Catalogue Number: FVL06080
• Device Lot Number: ANDW1387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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