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

Catalog Number FVL14120

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

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

Event Date 02/15/2024

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 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: thre delivery systems was returned for evaluation.The delivery system was found with the stent graft partially deployed and the outer sheath elongated.An attempt to deploy the stent graft was unsuccessful.In addition, the lumen of the delivery system could not be flushed, and a device compatible guidewire could not be advanced through the delivery system; the inner catheter was found protruding out of the proximal end of the system.There was visible contamination with clotted blood within the catheter.As there were no patency issues reported by the customer, it is reasonably suggested that the condition of the delivery system regarding impossibility to flush and to advance a guidewire occurred after the actual event due to coagulated blood.Photos of the device have been provided previously; however, as the delivery system were returned to investigation site, these photos did not provide and relevant information.It was reported that a 12f introducer / 0.035" guidewire were used for access, the tracking vessel was not heavily curved but a little calcified, the lesion was pre-dilated, and the device was flushed before use.Based on available information and evaluation of the returned sample, the investigation is closed with confirmed results for partial deployment.A definite root cause for the reported event could not be determined.The intended use of this device in the right superficial femoral artery 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 instructions 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 instructions for use states: the instructions 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 9f and a 0.035" guidewire.The fluency plus vascular stent graft is indicated for the treatment of atherosclerotic lesions in the iliac arteries.The intended use of this device in the right superficial femoral artery represents an off-label use.H10: d4 (expiration date: 09/2026) 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, the device allegedly did not deploy.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: 18938550
• MDR Text Key: 338681540
• Report Number: 9681442-2024-00053
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145377
• UDI-Public: (01)00801741145377
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: ANHW1959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• 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