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

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

Patient Problems Bradycardia (1751); Hemolysis (1886); Renal Failure (2041); Vomiting (2144); Swelling/ Edema (4577)

Event Date 02/10/2021

Event Type  Injury  

Event Description

It was reported via a journal article that an acute kidney injury occurred following treatment with an angiojet thrombectomy catheter for an occluded femoral vein stent.A 29 ear old caucasian male with a known left flank symptomatic venous malformation (vm) was admitted with a 2-day history of left leg pain, swelling and discolouration secondary to dvt.There was no history of chest pain, shortness of breath or palpitations.A year prior he had undergone left common-iliac vein stenting for a non-thrombotic iliac vein lesion, to redirect venous return away from the vm.As he remained symptomatic following this procedure, elective surgical excision-and-tie of the main feeder vessel to the vm was performed three weeks prior to this presentation.Bleeding at the time of this operation led to apixaban, that he was previously on, to be stopped.He had no other past medical history, including no known history of renal impairment, and no family history of renal disease.At the time of presentation cardiorespiratory examination was unremarkable.Examination of the abdomen revealed a firm, palpable mass in the left abdominal wall, consistent with the known vm.The left upper leg was swollen with mottling of the skin, but otherwise soft and non-tender, and peripheral pulses were intact.7500 units twice daily of low molecular weight heparin (lmwh) were commenced at the time of presentation.Following ct venography and duplex ultrasonography, that identified an occluded venous stent, angiojet thrombectomy and venoplasty were performed under general anaesthetic by the vascular surgical team.Pre-operative clotting markers were all within normal limits (inr 1.1, aptr 1.1).Intraoperatively, 8000 units of unfractionated heparin were administered, followed by 15000 units of lmwh one hour post-procedure.Successful recanalisation of the thrombosed stent was achieved.In the postoperative period he developed bradycardia and vomiting, and was treated with antiemetic and intravenous fluids.Vomiting settled after 36 hours.He remained haemodynamically stable throughout.Following surgical intervention a continuous intravenous heparin infusion was commenced, to prevent re-occlusion of the stent.His renal function was noted to decline immediately postop, from a baseline serum creatinine of 77 micromole/liter to 168 micromole/liter.The patient passed dark red urine, which on urine dipstick tested positive for blood.Renal function continued to decline over the coming 48 hours.Laboratory investigations demonstrated serum lactate dehydrogenase (ldh) to be elevated at 1148 u/l and haptoglobin level low at 0.3 g/l, haemoglobin fell post-procedure from 145 to 86 g/l.Direct antiglobulin test was negative.Blood tests performed pre-procedure and within 72 hours post-procedure are shown in table 1.Acute renal screen blood tests and virology were all negative.An ultrasound of the kidneys and urinary tract demonstrated normal sized (right 12.5 cm, left 11.9 cm), unobstructed kidneys bilaterally, with a diffuse increase in renal echogenicity and loss of corticomedullary differentiation.Incidentally the spleen was noted to be enlarged at 13 cm.A duplex ultrasound confirmed patent renal vasculature, and good perfusion of both kidneys.The patient was transferred to the renal ward 72 h postprocedure due to an ongoing decline in renal function and fall in urine output.He was initially managed with intravenous 1.26% sodium bicarbonate and 0.9% sodium chloride solutions, to maintain a positive fluid balance.However, urine output continued to fall and he started to develop evidence of fluid overload.After a further 48 hours, intermittent haemodialysis (hd) was commenced via a right internal jugular vein vascath.Four sessions of hd were completed in total.He subsequently started to show signs of renal recovery with polyuria, passing over 3 litre of clear urine per day.A decision was made not to perform a renal biopsy in view of the high risk of bleeding given the concomitant heparin infusion.He was discharged with a falling creatinine and once loaded on warfarin.At the time of writing the patients renal function had improved to near baseline, with a serum creatinine of 90 micromole/liter.

Manufacturer Narrative

Initial reporter facility name: (b)(6).Journal article citation: roper, tayeba, et al."unclogging the effects of the angiojet thrombectomy system on kidney function: a case report." journal of medical case reports 15.1 (2021): 1-6.

• 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: 14682523
• MDR Text Key: 294028396
• Report Number: 2134265-2022-06566
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2022

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
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/13/2022
• 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: 29 YR
• Patient Sex: Male
• Patient Race: White