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

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

Patient Problems Hematoma (1884); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Renal Failure (2041); Hematuria (2558); Insufficient Information (4580)

Event Date 03/06/2021

Event Type  Injury  

Event Description

It was reported via journal article that patient complications occurred following treatment for acute pulmonary embolisim (pe) using angiojet rheolytic thrombectomy (art)with an angiojet catheter.A total of 56 patients with pe with ihr or hr status were treated with art.Patient characteristics, comorbidities, and treatment patterns are presented in table 1.Baseline risk statuses were ihr or hr in 78.6% and 21.4% of the patients, respectively.The median time delays from symptoms to art treatment and from art to post-procedural ct acquisition were 3.5 (2 to 5.25) and 5 (4 to 6) days, respectively.Moreover, art was performed after the failure of systemic t-pa or ultrasound-assisted thrombolysis in 5 patients, and ct measures obtained after termination of t-pa infusion were used as baseline reference for assessing the efficacy of art in these cases.Absolute or relative contraindications for t-pa, including active bleeding from esophageal varices, recent or active major bleeding, in-hospital pe immediately after major surgery, and intracranial metastasis or bleeding were noted in 10 (83.3%) patients at hr and in 20 (45.4%) patients at ihr (table 1).The system catheters were successfully placed in all the patients.Unilateral and bilateral art treatments were needed in 22 (39.3%), and 34 (60.7%) patients, respectively.Bilateral art treatments were needed in 33.3% of the patients at high-risk and 68.2% of the patients at intermediate-high risk.Overall, the art activation duration was 304 (246 to 468) seconds.Adjuvant t-pa was used in 19 (33.9%) patients, and the lytic dosage was 15 mg (10 to 20).The tpa was given intravenously to 9 patients; the median intravenous dose was 27.5 mg for both groups, and the median infusion duration was 6 hours for ihr and 2 hours for hr patients.Mechanical ventilation and extracorporeal membrane oxygenation (ecmo) were needed in 5 and 2 patients, respectively (table 1).Treatment characteristics were comparable between patients at hr and ihr.All the clinical, echo, and ct measures of rv systolic strain and dysfunction, qs, and pa pressure estimates were significantly improved after art (fig.1, table 2).Comparison of improvements in these measures between hr versus ihr subgroups, and older versus younger age groups according to the cut-off limit of 65 years is given in table 3.Transient bradyarrhythmias spontaneously terminating immediately after deactivation of art were noted in 18 (32.1%) of patients and were comparable between risk groups (table 4).Gross hemoglobinuria following art was uniformly observed.However, hemoglobinuria recovered within 24 hours in all the patients with saline over hydration.Transient renal failure was noted in 22 (39.3%) patients regardless of the risk groups (table 4).Penalized logistic regression revealed that age was the only independent predictor of post-procedural nephropathy [age 50 to 73, odds ratio (or) 2.12 (1.05 to 4.24), 95% confidence interval (ci) 1.05 to 4.24, p=0.034] (table 5).During a hospital stay of a median of 13 (iqr 9 to17) days, 5 (8.9%) patients died; and intracranial and unresolved severe pe were associated with mortality in 1 (1.8%) and 4 (7.1%) patients, respectively (table 4).Ecmo was needed in 2 of the 4 of these mortal cases.Non-fatal major bleeding was documented in 4 (7.1%) patients and included intracranial, hemoptysis, and gastrointestinal bleeding in 1, 1, and 2 episodes, respectively.Minor bleeding events were noted in 7 (12.5%) patients; and groin hematoma, hemoptysis, hematuria, hemorrhoidal, and menstrual bleeding were observed in 1, 3, 1, 1, and 1 episode, respectively.Hr versus ihr statuses were associated with higher in-hospital mortality (33.3% versus 2.3%, p=0.006), whereas major or minor bleeding rates were comparable (p=0.999 and p=0.325, respectively) (table 4).

Manufacturer Narrative

Date of event: no date provided, used the acceptance date of the article.Initial reporter facility name: departments of cardiology, and anesthesiology, hamidiye faculty of medicine, university of health sciences turkey,kosuyolu heart training and research hospital akbal, o.Y., keskin, b., tokgoz, h.C., hakgor, a., karagoz, a., tanyeri, s.,.& kaymaz, c.(2021).A seven-year single-center experience on angiojet rheolytic thrombectomy in patients with pulmonary embolism at high risk and intermediate-high risk.Anatolian journal of cardiology, 25(12), 902-11.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14787025
• MDR Text Key: 295027184
• Report Number: 2134265-2022-06817
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/23/2022
• 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): Other; Hospitalization