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

Catalog Number FVL14120

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

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure via right femoral vein, the sheath was allegedly unable to be released when pushing the stent.It was further reported that, after multiple attempts were made, it was found that the delivery system had a problem.Reportedly, after removal out of the body, the stent was allegedly still unable to be released.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 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 in d2 and g4.H10: manufacturing review: the lot history records of this lot were 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent graft delivery system was returned for evaluation.As the stent graft was found partially deployed upon sample receipt, it is confirmed that the stent graft could not be deployed in the patient.The outer sheath of the delivery system was fractured, which is considered being a result of increased forces during deployment.It was reported that a 10f introducer sheath and 0.035" guidewire were used for access, which meets the recommendations of the instruction for use.Based on evaluation of the device sample returned it is confirmed that the stent graft could not be deployed in the patient.The stent graft was found partially deployed upon sample receipt and the outer sheath of the delivery system was found fractured.Based on information available a definite root cause for the reported issue could not be determined.However, the intended use of the device in the superior vena cava represents an off-label use.Labeling review: relevant labeling supplied with this product was reviewed.The instruction for use was found to sufficiently address the potential risks.Regarding preparation of the device the instruction for use states: "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 instruction 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 instruction for use states: " 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 10f and a 0.035" guidewire.The intended use of the device in the superior vena cava represents an off-label use.Based on the instruction for use supplied with this product the fluency plus vascular stent graft is indicated for use in the iliac and femoral arteries.H10: (expiry date: 08/2024).H11: section a through f - the information provided by bd 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 bd.H3 other text : see h10.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17717996
• MDR Text Key: 323044642
• Report Number: 9681442-2023-00320
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145377
• UDI-Public: (01)00801741145377
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL14120
• Device Lot Number: ANFV0119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• 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