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

Catalog Number UNK FLUENCYPLUS VASC STNT GRFT

Device Problem Obstruction of Flow (2423)

Patient Problems Occlusion (1984); Stenosis (2263); Blood Loss (2597)

Event Date 09/24/2017

Event Type  Injury  

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 510 k number and pro code for the fluency plus endovascular stent graft products are identified.As the lot number for the device was not provided, a manufacturing review could not 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.(b)(4).Journal article citation: wan, y.-m., li, y.-h., xu, y., wu, h.-m., li, y.-c., wu, x.-n., & yang, j.-h.(2018).Predictors of shunt dysfunction and overall survival in patients with variceal bleeding treated with transjugular portosystemic shunt creation using the fluency stent graft.Academic radiology, 25(7), 925¿934.Doi: 10.1016/j.Acra.2017.11.020.

Event Description

It was reported in an article from the journal of academic radiology titled " predictors of shunt dysfunction and overall survival in patients with variceal bleeding treated with transjugular portosystemic shunt creation using the fluency stent graft " that periprocedural complications were observed in 53 patients: nausea and vomiting (25), bleeding from the puncture site at the neck (16), transient respiratory distress and tachycardia (7), and hepatic capsular puncture leading to intraabdominal bleeding (5), which were successfully managed by conservative treatment.Stent dysfunction was identified in 63 patients; 30 had shunt stenosis and 33 had shunt occlusion.62 underwent transjugular intrahepatic portosystemic shunt (tips) revisions, including balloon angioplasty, thrombectomy, thromboaspiration, and thrombolysis combined and insertion of one or two new stent grafts.The status of the patients was not provided.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9344739
• MDR Text Key: 168102048
• Report Number: 9681442-2019-00229
• Device Sequence Number: 1
• Product Code: PFV
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCYPLUS VASC STNT GRFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• 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): Other; Required Intervention