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

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

Patient Problem Ischemia Stroke (4418)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Date of event estimated using date journal article was first published.Aasen, m., & blecha, m.(2021).Percutaneous revascularization for covid-19 induced spontaneous arterial thrombosis.Vascular and endovascular surgery, 55(7), 781 through 786.Https://doi.Org/10.1177/15385744211010445.

Event Description

It was reported via journal article that a patient experienced an ischemic stroke following an angiojet procedure.A patient who had been admitted to the hospital for 7 days with covid pneumonia developed the acute onset of right foot pain and numbness.The patient was non-ventilated but did require supplemental oxygen.Vascular surgery consult was obtained and emergent heparinization and angiography were undertaken.Angiogram revealed complete thrombosis of the right superficial femoral artery (sfa), popliteal, and all 3 tibial arteries.Angiojet percutaneous mechanical thrombectomy (pmt) of the sfa, popliteal and posterior tibial arteries was performed.A flow channel was achieved through the level of the knee, but the tibial arteries remained thrombosed.Tpa drip via lytic catheter was therefore initiated.That evening, the patient developed bilateral acute ischemic strokes with a small area of hemorrhagic conversion.Anticoagulation and tpa were thus urgently discontinued, but by that time the patient had developed an outstanding posterior tibial artery doppler tone.D-dimer level was noted to peak at 25,020 ng/ml.Despite significant neurological compromise from the stroke, the right leg remained well perfused with normal ck levels and biphasic doppler waveforms at last examination at the time of discharge to nursing facility 4 weeks after admission.

• 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: 14738484
• MDR Text Key: 294542010
• Report Number: 2134265-2022-07009
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2022

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: 05/24/2022
• Initial Date FDA Received: 06/17/2022
• 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): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male