MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number UNK481

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Literature citation: endovascular stenting in the management of malignant superior vena cava obstruction: comparing safety, effectiveness, and outcomes between primary stenting and salvage stenting, hong kong med j , volume 21 number 5, october 2015.The device was not received for analysis.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

Reported via journal article that within this study, it was reported that a hematoma occurred.Wallstent endoprostheses were used in all patients in this study to compare the safety, effectiveness, and outcomes of primary stenting and salvage stenting for malignant superior vena cava obstruction.Intravenous heparin was administered before stent placement.Pre-procedure superior vena cavograms were performed for assessment of site, length, degree of stenosis, and planning of stent placement.The stenoses were first negotiated with a guidewire.Placements of wallstents across the stenoses were then performed.Balloon angioplasty was performed before and/or after stent placement if considered necessary by the performing interventional radiologist.Stent position and patency were confirmed by post-procedural superior vena cavogram.Procedure-related complications included haemopericardium, acute pulmonary oedema and bleeding- related complications, groin haematoma, arterial.One periprocedural death occurred due to fatal haemopericardium.

• Brand Name: WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7184258
• MDR Text Key: 97055760
• Report Number: 2134265-2017-13128
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K992510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2017
• 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