MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET; CATHETER, CORONARY, ATHERECTOMY

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

Patient Problems Encephalopathy (1833); Hematoma (1884); Hematuria (2558)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: event date approximated based on first date listed in journal.Journal citation: li, z., zhang, w., jiao, d.-c., zhou, x., zhou, p., si, g., & han, x.(2021).Clinical study of transjugular intrahepatic portosystemic shunt combined with angiojet thrombectomy for acute portal vein thrombosis in non-cirrhosis.Medicine, 100:6.Retrieved from https://journals.Lww.Com/md-journal/fulltext/2021/02120/clinical_study_of_transjugular_intrahepatic.33.Aspx.

Event Description

It was reported via journal article that within a study, patients experienced hematoma, hematuria and hepatic encephalopathy after treatment.Twenty-three patients were enrolled in this study to evaluate the clinical efficacy of transjugular intrahepatic portosystemic shunt (tips) combined with sequential thrombectomy using the angiojet device in the treatment of patients with non-cirrhotic acute portal vein thrombosis (apvt).A transjugular approach was used in all patients and the transhepatic puncture was performed under ultrasound guidance.A non-boston scientific hydrophilic guidewire was treated through the puncture cannula and a 5-fr non-boston scientific vertebral catheter was advanced into the portal vein (pv).Mechanical thrombectomy was then performed on the pv and superior mesenteric vein (smv) by a guidewire placed in a non-boston scientific thrombus aspiration catheter.The patient was treated with urokinase 300,000 u (dissolved into 100ml of normal saline) and the aspiration catheter was subjected to thrombus aspiration at a rate of 1mm/s along the guidewire.Despite the significant reduction in thrombus burden, venous blood flow has not been fully restored, so we inserted a porous infusion catheter along the smv and performed 24-hour thrombolytic therapy with a high dose of urokinase (100,000 units/hr).In addition, 5000 iu of low molecular weight heparin (lmwh) was injected twice a day, and warfarin was administered after treatment at an initial dose of 5mg.Thrombolysis time depended on the improvement of patients clinical symptoms, decrease in d-dimer, and imaging data.The lmwh was discontinued when the international normalized ratio was maintained at 2.0 to 3.0, and warfarin therapy for at least six months followed by 100 mg/d aspirin monotherapy for a lifetime.All patients were followed up at twelve months after treatment.Laboratory testing (coagulation function, routine blood test) and cta/doppler ultrasound were performed at each arranged follow-up visit, or whenever clinically required (eg, for ascites, black stools, or abdominal pain).During follow-up, no blind method was adopted for patients taking warfarin.The patients were followed up for an average of 12 months.Twenty-four hours after combined treatment, pv thrombosis grade was improved significantly.The one-year overall survival rate was 100% (23/23).Minor complications included hematoma, hematuria, and hepatic encephalopathy.After one week of treatment, ct scan revealed 8.7% (2/23) cases of hepatic envelope hematoma (thickness less than 2cm).Hemoglobinuria occurred in 18/23 (78.3%) patients after treatment and returned to normal within 1 to 2 days.Two patients 2/23 (8.7%) had transient grade i encephalopathy after tips, and all of them were relieved after medical combination therapy.

• Brand Name: ANGIOJET
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11790490
• MDR Text Key: 249471656
• Report Number: 2134265-2021-05864
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other