MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

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

Patient Problems Bradycardia (1751); Hematoma (1884); Hemorrhage/Bleeding (1888); Thromboembolism (2654); Ischemia Stroke (4418); Thrombocytopenia (4431)

Event Date 06/28/2021

Event Type  Injury  

Event Description

It was reported via a journal article that hospitalization occurred after treatment with ultrasound-assisted thrombolysis.Abstract.Objectives the aim of this trial was to determine whether ultrasound-assisted thrombolysis (usat) is superior to standard catheter-directed thrombolysis (scdt) in pulmonary arterial thrombus reduction for patients with submassive pulmonary embolism (spe).Background catheter-directed therapy has been increasingly used in spe and massive pulmonary embolism as a decompensation prevention and potentially lifesaving procedure.It is unproved whether usat is superior to scdt using traditional multiple side hole catheters in the treatment of patients with pulmonary embolism.Methods adults with spe were enrolled.Participants were randomized 1:1 to usat or scdt.The primary outcome was 48-hour clearance of pulmonary thrombus assessed by pre- and postprocedural computed tomographic angiography using a refined miller score.Secondary outcomes included improvement in right ventricular to left ventricular ratio, intensive care unit and hospital stay, bleeding, and adverse events up to 90 days.Results eighty-one patients with acute spe were randomized and were available for analysis.The mean total dose of alteplase for usat was 19 7 mg and for scdt was 18 7 mg infused over 14 6 and 14 5 hours, respectively.In the usat group, the mean raw pulmonary arterial thrombus score was reduced from 31 4 at baseline to 22 7.In the scdt group, the score was reduced from 33 4 to 23 7.There was no significant difference in mean thrombus score reduction between the 2 groups.The mean reduction in right ventricular/left ventricular ratio from baseline (1.54 0.30 for usat, 1.69 0.44 for scdt) to 48 hours was 0.37 0.34 in the usat group and 0.59 0.42 in the scdt group.Major bleeding (1 stroke and 1 vaginal bleed requiring transfusion) occurred in 2 patients, both in the usat group.Conclusions in the sunset spe (standard vs.Ultrasound-assisted catheter thrombolysis for submassive pulmonary embolism) trial, patients undergoing usat had similar pulmonary arterial thrombus reduction compared with those undergoing scdt, using comparable mean lytic doses and durations of lysis.

Manufacturer Narrative

Date of event: publication of literature article used as event date.(b)(6).Avgerinos, efthymios d., et al."randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism: the sunset spe trial." jacc: cardiovascular interventions 14.12 (2021): 1364-1373.

• Brand Name: EKOSONIC KIT 106CM 12CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12941332
• MDR Text Key: 281844278
• Report Number: 2134265-2021-14691
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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
• Date Manufacturer Received: 11/15/2021
• 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