MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY

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

Patient Problems Abdominal Pain (1685); Pseudoaneurysm (2605)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

Yu, zuanbiao, jiangnan hu, and dehai lang."pseudoaneurysm as a rare complication in the treatment of superior mesenteric artery embolism via percutaneous mechanical thrombectomy: a case report." journal of international medical research 49.6 (2021): 03000605211022941.

Event Description

It was reported via journal article that a pseudoaneurysm occurred.A (b)(6) man presented to a general practitioner because of an 8-hour history of sudden-onset acute pain around the umbilicus.Ten days before the symptoms occurred, he had been diagnosed with infective endocarditis, and a blood culture revealed hemolytic streptococcus during hospitalization.A complete antibiotic treatment course was completed before the patient presented to our center (hwa mei hospital, university of chinese academy of sciences).After treatment, no bacterial growth was found in a late blood culture, and cardiac color ultrasound revealed no mitral valve or aortic valve vegetations.In addition, the patient had no other pertinent medical history, such as a connective tissue disorder.During this period, he developed no signs of peritoneal irritation or symptoms of intestinal necrosis, such as black stool.A blood panel showed a white blood cell count of 6.4109/l.The patient maintained consciousness, and his blood pressure was within the normal range.Computed tomography (ct) angiography of the abdominal region showed superior mesenteric artery embolization.Considering that the patient had no signs of intestinal necrosis, emergency surgery was performed in the digital subtraction angiography catheter room after the patient had provided written informed consent.During the operation, the right femoral artery was punctured, and a 6-fr angiojet thrombectomy catheter (solent omni, boston scientific, marlborough, ma, usa) was used to achieve the thrombectomy.We operated the angiojet catheter five times, and the total duration of the aspirations was 150 s.Subsequent imaging showed that the blood flow of the distal main artery was significantly improved without obvious contrast agent extravasation.The patient's symptoms improved after the thrombectomy, and no liver or kidney damage was detected after the surgery.However, 7 days after the endovascular procedure, the patient developed recurrent acute abdominal pain accompanied by abdominal muscle tension.Ct angiography of the superior mesenteric artery indicated the presence of a pseudoaneurysm in middle part of the distal superior mesenteric artery with active extravasation.The patient was immediately scheduled for abdominal surgery under general anesthesia.During laparotomy, we found that the blood supply of the bowel was acceptable, no intestinal necrosis was found.The pseudoaneurysm was carefully resected, and some of the thrombus was further removed by a 3-fr fogarty catheter.No infected vegetation was detected during the whole process.Furthermore, we repaired the superior mesenteric artery, which contained two holes with rupture-induced hemorrhage (22 mm).For this procedure, we did not use patches because of the small diameter of the superior mesenteric artery.After the operation, the blood flow normalized and the peritoneal cavity was surgically closed.Two weeks postoperatively, the patient recovered without complications and was discharged with a prescription of oral aspirin.The patient provided written consent for publication of this case report.We performed follow-up by telephone, and no symptoms or complaints were reported 1 month postoperatively.Percutaneous mechanical thrombectomy is a safe and effective treatment for addressing thrombosis in various embolic diseases.In recent years, this approach has also been actively applied in the management of acute embolic occlusion of the superior mesenteric artery.A pseudoaneurysm as a complication of this operation is remarkably rare.This is the first case report of the diagnosis and treatment of a pseudoaneurysm that developed as a complication after the application of percutaneous mechanical thrombectomy via an angiojet device for thrombolysis in the superior mesenteric artery.

• Brand Name: ANGIOJET SOLENT OMNI
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12616223
• MDR Text Key: 275921616
• Report Number: 2134265-2021-12632
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2021

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: 09/30/2021
• Initial Date FDA Received: 10/12/2021
• 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): Required Intervention
• Patient Age: 37 YR