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

Catalog Number FVM14040

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Malposition of Device (2616); Material Deformation (2976)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure, the stent allegedly failed to deploy.It was further reported that the sheath was allegedly damaged.There was no reported patient injury.

Manufacturer Narrative

The catalog number 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 common device name and pma/510k.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 02/2025.

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: 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 delivery system was returned with the stent graft completely deployed.No defect of the delivery system or any indication for a device deficiency could be determined.The spring coil element alleged to be kinked was found to meet its specification.The submitted image shows an x-ray of the distal end of the delivery system in the target vessel during the stent graft deployment process.The gap respectively the in the spring coil element that an arrow points at, is a part of the design of the delivery system.The target vessel in this case was reportedly torturous.The system was flushed, and device compatible accessories were reported to be used.Based on the evaluation of the sample returned and the information provided, no defect and indication for a device failure could be determined and the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.The reported use of the device in the pulmonary artery 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.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 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 10f and a 0.035" guidewire.The reported use of the device in the pulmonary artery represents an off label use of the device.Based on the labeling supplied with this product, the fluency plus vascular stent graft is indicated for the use in the iliac and femoral arteries.H10: d4 (expiry date: 02/2025), g3.H11: b3, b5, h6 (device, result, conclusion).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.

Event Description

It was reported that during a stent graft placement procedure, the sheath was allegedly damaged at the beginning of the procedure before any deployment maneuver.It was further reported that the device allegedly had difficulty in deployment and positioning of the stent, too distal, responsible for immediate occlusion.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: 16467091
• MDR Text Key: 310515083
• Report Number: 9681442-2023-00056
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145858
• UDI-Public: (01)00801741145858
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVM14040
• Device Lot Number: ANGP1683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• 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