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

Catalog Number FVM14100

Device Problem Misfire (2532)

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

Event Date 02/20/2024

Event Type  malfunction  

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 that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2025) h11: section a through f ¿ the information provided by bd represents all 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 : device pending return.

Event Description

It was reported that during a stent graft placement procedure in right iliac aneurysm via homolateral femoral access, weaning the ring, flushing the sheath, closing the valve, raising the stent and then as the ring was loosed, the stent allegedly failed to deploy beyond one centimeter.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 that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.H10: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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.Investigation summary: the delivery system sample was returned for evaluation with the stent graft completely deployed.The outer sheath was elongated; however, no damages of the device were found that may be related to the reported incomplete stent graft deployment.It was reported that an 11f introducer and a 0.035inch guide wire were used for access, the tracking vessel was neither tortuous nor calcified, the lesion was not predilated and the device was flushed prior to use.Based on available information and the evaluation of the returned sample, the investigation is closed with inconclusive results for partial deployment.A definite root cause for the reported event could not be determined.The intended placement of this device to treat an aneurysm represents an off-label use.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding anatomy the instruction for use states "if excessive force is felt during stent graft deployment, do not force the delivery system.Remove the delivery system and replace with a new unit".Regarding preparation of the device the instruction for use states: the instruction for use states: "prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment.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 10f and a 0.035" guidewire.The instruction for use states that, the fluency plus vascular stent graft is indicated for the treatment of atherosclerotic lesions in the iliac arteries.The safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.H10: d4 (expiration date: 07/2025).H11: section a through f ¿ the information provided by bd represents all 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.

Event Description

It was reported that during a stent graft placement procedure in right iliac aneurysm via homolateral femoral access, weaning the ring, flushing the sheath, closing the valve, raising the stent and then as the ring was loosed, the stent allegedly failed to deploy beyond one centimeter.The procedure was completed using another device.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18924438
• MDR Text Key: 337911482
• Report Number: 9681442-2024-00050
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145889
• UDI-Public: (01)00801741145889
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVM14100
• Device Lot Number: ANGU3138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• 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
• Patient Age: 68 YR
• Patient Sex: Male