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

Catalog Number FVL09120

Device Problems Positioning Failure (1158); Fracture (1260); Misfire (2532); Material Deformation (2976)

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

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified 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.Manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 sample was returned to the manufacturer for evaluation.Based on the investigation of the returned catheter sample, it is confirmed that the user could only partially deploy the stent graft.The outer sheath was found fractured which made a successful deployment impossible.The outer sheath was found twisted and deformed and it is not known when and how this was caused.The forces applied during deployment would not have caused this issue because the deployment notion creates no rotation, however, it is considered as part of the investigation.Thus, the partial deployment of the stent graft and the deformation of the outer sheath are confirmed as being cascading events of the fracture of the outer sheath.In this case, the proximal end of the stent graft was placed in a straight section of the lumen, and resistance was felt during deployment attempt.Therefore, the investigation is confirmed for the 'fracture' as the main issue and 'misfire' and 'material deformation' as the cascading events.A definite root cause for the reported event could not be determined.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 9f and a 0.035" guidewire.Expiry date: 03/2023.

Event Description

It was reported that during a stent placement procedure in the right external iliac artery to treat an occlusion, the stent allegedly failed to deploy.The procedure was completed by 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13059823
• MDR Text Key: 283088176
• Report Number: 9681442-2021-00637
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145193
• UDI-Public: (01)00801741145193
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVL09120
• Device Lot Number: ANEQ0823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• 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