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

Catalog Number UNK FLUENCYPLUS VASC STNT GRFT

Device Problem Obstruction of Flow (2423)

Patient Problems Occlusion (1984); Stenosis (2263)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

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.Journal article citation: li, y.-h., xu, z.-y., wu, h.-m., yang, l.-h., xu, y., wu, x.-n., & wan, y.-m.(2018).Long-term shunt patency and overall survival of transjugular intrahepatic portosystemic shunt placement using covered stents with bare stents versus covered stents alone.Clinical radiology, 73(6), 580¿587.Doi: 10.1016/j.Crad.2018.01.014.[(b)(4)].

Event Description

It was reported in an article from the journal of clinical radiology titled " long-term shunt patency and overall survival of transjugular intrahepatic portosystemic shunt placement using covered stents with bare stents versus covered stents alone " that shunt dysfunction occurred in 63 patients.Among them, 11 patients in group a and 19 in group b developed shunt stenosis, while 17 patients in group a and 16 in group b had shunt occlusion.Overall, 62 patients with shunt dysfunction received tips revisions, including balloon angioplasty thrombectomy, thromboaspiration, and thrombolysis combined with balloon angioplasty and deployment of one or two new stents combined with balloon angioplasty.Thirteen patients received repeated tips revisions resulting in 27 revisions.Tips revisions were unsuccessful in three patients who had a thrombosis that was impermeable to the needle.The status of the patients was not provided.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR 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: 9316487
• MDR Text Key: 166208890
• Report Number: 9681442-2019-00212
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 10/17/2019
• 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