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

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

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Renal Failure (2041); Vomiting (2144)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated to (b)(6) 2020, the first published date of the article.Article source: turk, t., blaskovic, d., smiljanic, r., & vidjak, v.(2020).Acute kidney injury following percutaneous mechanical thrombectomy of subclavian artery stent graft thrombosis: a case report.Cvir endovascular.Volume 3 (issue 27).

Event Description

It was reported that dialysis-requiring acute kidney injury occurred.A patient was evaluated for subclavian artery aneurysm causing distal embolization and hand ischemia.A computed tomography angiography showed aneurysm of extrathoracic segment of left subclavian artery.A 10x150 mm non-bsc stent graft was placed via a left brachial approach.Post procedure, patient had a good clinical outcome and was recommended to take dual antiplatelet therapy medication for six months, and one-month post procedure showed good graft patency.The patient returned three months later with sudden onset of left arm pain and pallor.Ultrasound showed graft thrombosis and patient confirmed that she was not taking antiplatelet therapy regularly.Angiojet percutaneous mechanical thrombectomy (pmt) was performed after thrombus lacing with 10 mg of t-pa with a total aspiration time of 180 seconds.Postinterventional angiography showed good graft patency.A total amount of 60 ml of nonionic contrast media was used.At the end of the procedure, the patient became agitated, with blood pressure 230/120 mmhg, chest pain and vomiting, they were transferred to intensive unit where myocardial infarction was excluded.The patient became oliguric with elevated serum creatinine of 285 umol/l (prepocedural serum creatinine was 120 umol/l, egfr 41 ml/min/1.73m2).Blood tests at 48 h postprocedure showed significant drop in hematocrit (0,433 l/l to 0,284 l/l) as a marker of intravascular hemolysis as well as elevated ldh (1521 u/l), ast (303 u/l) and alt (165 u/l).Due to acute kidney injury (aki) and continuous rise in serum creatinine, urgent renal replacement therapy was initiated.The peak value of serum creatinine was 827 umol/l on 7th postprocedural day.After 4 session of haemodialysis within 2 weeks, the patient's renal function entered a polyuric phase and subsequent recovery without further need for hemodyalisis.Renal duplex sonography showed normal renal vasculature.Urine tests showed no signs of nephritis, no co-medication or concomitant disease was identified as a probable cause of renal failure.On final discharge, the patient was anticoagulated with clopidogrel.During the 12-month follow ups, the left subclavian and axillary artery remained patent.Unfortunately, the patient died 12 months after pmt therapy due to traumatic incident.

• 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: 10374871
• MDR Text Key: 201935762
• Report Number: 2134265-2020-10563
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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: 08/06/2020

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: 07/28/2020
• Initial Date FDA Received: 08/06/2020
• 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): Required Intervention
• Patient Age: 66 YR