MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZELANTEDVT CLOTHUNTER; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	45027
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Anemia (1706); Hemorrhage/Blood Loss/Bleeding (1888); Nausea (1970); Vomiting (2144); Hematuria (2558); Pancreatitis (4481); High White Blood Cell Count (4594)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via journal article, a rare case acute pancreatitis following percutaneous mechanical thrombectomy of left common iliac vein.This angiojet zelante dvt clothunter was chosen as treatment for left common iliac vein balloon venoplasty with denali ivc filter insertion for pulmonary embolism prevention.The patient tolerated the procedure without immediate complication and was discharged home.Unfortunately, over the course of the evening the patient developed acute onset upper abdominal discomfort that radiated to her back.The symptoms were associated with severe nausea, multiple episodes of bloody non-bilious vomiting and dark cola-colored urine.On presentation, the patient was hemodynamically stable.Physical examination was notable for a soft and non-distended abdomen with active bowel sounds, but diffuse tenderness to palpation, most pronounced in right upper quadrant, without peritoneal signs.Initial laboratory analysis revealed an elevated white blood cell count (18.9 k/ul), blood urea nitrogen (34 mg/dl), creatinine (1.80 mg/dl), high-sensitivity troponin (11,711 ng/l), lactic acid (5.6 mmol/l), and lipase (1538 units/l).Lipid panel was obtained for rule out hypertriglyceridemia for a possible cause of pancreatitis, that was within normal.Urinalysis showed dark yellow urine positive for blood, bilirubin, and urobilinogen.Initial electrocardiogram revealed no ischemic changes.Computed tomography (ct) gastrointestinal bleed protocol showed fatty infiltration of the pancreatic head with concerns for necrotizing pancreatitis with no presence of cholelithiasis.The patient was admitted to the intensive care unit and ceftriaxone, metoclopramide, zofran, morphine, and fluids were initiated.Heparin drip was also started given the associated troponin elevation and concern for non-st elevation myocardial infarction (nstemi).The hospital course initially complicated by hematemesis and melena with a marked hemoglobin decline (15.4 g/dl to 7.0 g/dl), requiring transfusion of two units of packed red blood cells and heparin discontinuation.With continued conservative management, her abdominal pain and vomiting gradually resolved, but she remained unable to tolerate oral intake, necessitating fluoroscopy guided nasojejunal tube (nj) tube placement and tube feedings.No evidence of obstruction was appreciated on ct or abdominal radiographs.Over the course of the next five days she demonstrated gradual symptomatic improvement, was challenged with heparin without complication, and transitioned to xarelto on discharge.In conclusion, pancreatitis secondary to percutaneous mechanical thrombolysis is a relatively rare phenomenon dependent not only on predisposing patient factors (renal function), but also upon target factors (clot size, clot location, local blood flow) and technician dependent factors (catheter saline jets).Further studies evaluating these factors may help in determining the risk of post-procedure pancreatitis as a function of hemolysis and free heme release.Pokharel, ashik; tu, xinhang; naqvi, haider a.; raza, rafi; and haas, christopher j.(2023) "acute pancreatitis following percutaneous mechanical thrombectomy of left common iliac vein," journal of community hospital internal medicine perspectives: vol.13: iss.3, article 18.Doi: 10.55729/2000-9666.1186.

• Brand Name: ZELANTEDVT CLOTHUNTER
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18676189
• Report Number: 2124215-2024-07372
• Device Sequence Number: 17946292
• Product Code: QEW
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K151313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female