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

Catalog Number FVM08060

Device Problem Obstruction of Flow (2423)

Patient Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the fluency plus vascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus vascular stent graft are identified in.As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 08/2022).

Event Description

It was reported that one year post stent placement in the main portal vein, patient experienced portal hypertension, splenic varices, and gastroscopy showed a positive red line sign for esophageal veins.It was further reported that upon surgery, it was identified that filling defect is seen in the lower part of the original covered stent.Reportedly the patient was diagnosed with portal hypertension, gastric fundus-esophageal varices after tips, intrahepatic stent thrombosis, stenosis and recurrence after gastric coronary vein thrombosis.The current status of the patient is unknown.

• 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: 12947647
• MDR Text Key: 281835370
• Report Number: 9681442-2021-00616
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145629
• UDI-Public: (01)00801741145629
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVM08060
• Device Lot Number: ANDV1161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Male