FDA Adverse Event Death Summary report: N

FLOW TRIEVER INARI MEDICAL

MDR report key: 12770527 · Received November 8, 2021

Report

Report Number
MW5105146
Event Type
Death
Date Received
November 8, 2021
Date of Event
October 27, 2021
Report Date
November 1, 2021
Manufacturer
INARI MEDICAL - OAK CANYON
Product Code
DXE
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

COVID-19 VACCINE: DOSE 3 GIVEN (B)(6) 2021, REFER TO GUIDELINES. CARE TEAM: NO PCP. COVERAGE: (B)(6). ALLERGIES: (4), HT: 1.575 M (5' 2"); BMI: 32.67 KG/M2. THIS WAS AN (B)(6) YEARS OLD FEMALE WITH PMHX OF HTN, DEPRESSION, KYPHOSCOLIOSIS, OA, GLAUCOMA PRESENTED WITH EXERTIONAL DYSPNEA , PRESENTED TO EMERGENCY ROOM AND FOUND TO HAVE ELEVATED TROPONIN TO >500 & BNP 186, INITIALLY THOUGH TO HAVE NSTEMI BUT ON SAME ADMISSION DAY EVENING NSTEMI DIAGNOSIS RULED OUT AS SHE WAS DIAGNOSED WITH PE WHICH EXPLAINED HER TROPONIN ELEVATION. CTA REPORT SHOWED (ACUTE PULMONARY ARTERY THROMBOEMBOLISM IDENTIFIED IN THE PROXIMAL RIGHT MAIN PULMONARY ARTERY BEGINNING AT THE LEVEL OF THE LEFT AND RIGHT MAIN PULMONARY ARTERY BIFURCATION EXTENDING INTO THE TRUNCUS ANTERIOR AND INTERLOBAR ARTERY AND INTO THE SEGMENTAL BRANCHES OF THE RIGHT UPPER AND MIDDLE LOBES, AND POSTERIOR BASAL SEGMENTS OF THE RIGHT LOWER LOBE. ACUTE PULMONARY ARTERIAL THROMBUS EMBOLISM IDENTIFIED IN THE DISTAL LEFT MAIN PULMONARY ARTERY EXTENDING INTO THE LEFT UPPER LOBE AND LINGULAR BRANCHES AND A LEFT LOWER LOBE BASAL SEGMENTAL ARTERY. PATIENT WENT TO INTERVENTIONAL RADIOLOGY DEPARTMENT FOR THE PROCEDURE (B)(6) 2021 , UNFORTUNATELY DEVELOPED ACUTE PULMONARY HEMORRHAGE INTRA-PROCEDURE AND LOST BP AND PULSE, CODE BLUE CALLED DURING CODE BLUE PATIENT WAS GIVEN MULTIPLE BLOOD TRANSFUSIONS AND OTHER MEDS, SHE WAS INTUBATED, HAD CPR, HAD EMERGENT THORACOTOMY BY THORACIC SURGERY IN IR DEPARTMENT IN ATTEMPT TO CONTROL HER PULMONARY HEMORRHAGE, YET ALL ATTEMPTS FAILED TO ACHIEVE RETURN OF SPONTANEOUS CIRCULATION (ROSC). CODE BLUE ENDED PER ICU INTENSIVIST WHO PRONOUNCED PATIENT DEAD AT 1:25 PM ON (B)(6) 2021.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1667228 FLOW TRIEVER INARI MEDICAL CATHETER, EMBOLECTOMY DXE INARI MEDICAL - OAK CANYON CATH FLOWTRIEVER ASP GUIDE 20F

Patients

Seq Age Sex Outcome Treatment
1 87 YR Female Death