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

Catalog Number FVL14120

Device Problem Misfire (2532)

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

Event Date 12/21/2023

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: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently h10: d4: (expiry date: 03/2026).H11: section a through f: the information provide 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 via the transfemoral approach, the stent was allegedly released for one third and could not be fully released.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent graft placement procedure via the transfemoral approach, the stent was allegedly released for one third and could not be fully 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: 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: no stent delivery system was returned for evaluation.However, photos of the devices were provided.Even though device with a partially deployed stent graft could be identified, assignment regarding stent size or lot number is not possible.In addition x-ray video files were provided are showing the aortic bifurcation of the patient, with an aortic graft and multiple stents of another manufacturer extending into the iliac arteries.Based on photos and video files no device deficiency could be identified.The stent grafts were intended during treatment of bilateral iliac aneurysms.It was reported that there were no tracking issues and device compatible accessories were used.Based on information available and as the sample was not returned for evaluation, the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.The intended treatment of aneurysms represents an off label use of the device.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.The instructions for use state: "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".There was no report of tracking/ insertion difficulty.Regarding preparation of the device the instructions for use state 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".Regarding accessories the instructions for use states: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended".The instructions for use states "pre-dilatation of the stenotic lesion may be performed prior to stent graft deployment at the discretion of the treating physician".With regards to precautions, the instructions for use states "the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established".H10: d4 (expiry date: 03/2026), g3 h11: h6 (method, result, conclusion) h11: section a through f: the information provide 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.

• 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: 18515780
• MDR Text Key: 333547599
• Report Number: 9681442-2023-00425
• 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: K133948
• 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,Followup
• Report Date: 02/09/2024
• 2 Devices were Involved in the Event: 1 2

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: FVL14120
• Device Lot Number: ANHQ2213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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