Triever20 21-101 (UDI 00850291007079)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00850291007079), received between Aug 19, 2017 and Feb 13, 2025 — classified as 8 deaths, 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Entrapment of Device; Difficult to Remove; Material Separation; Difficult to Advance; Entrapment of Device; Difficult to Remove; Material Separation; Difficult to Advance

  ON (B)(6) 2025, A 47-YEAR-OLD FEMALE UNDERWENT A DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A PREEXISTING INFERIOR VENA CAVA (IVC) FILTER. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 100 DAYS. DURING THE THROMBECTOMY, THE TREIVER20 CATHETER (T20) WAS ADVANCED WITHOUT AN INTRODUCER SHEATH INTO THE RIGHT POPLITEAL VEIN TO TARGET CLOT IN THE RIGHT FEMORAL VEIN. WHILE TRYING TO MOVE THE CATHETER WITHIN THE VESSEL, THE CATHETER BECAME STUCK AND WOULD NOT ADVANCE OR RETRACT. THE CATHETER THEN SEPARATED, LEAVING THE TWO HALVES CONNECTED BY THE INNER COIL. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER USING A MUSTANG BALLOON; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. AFTER TWO DOSES OF NITROGLYCERIN WERE ADMINISTERED, THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER IN FULL BY TWISTING IT CLOCKWISE. THERE WERE NO INJURIES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21380045 ↗
• InjuryDec 5, 2024Use of Device Problem; Use of Device Problem

  AN 82-YEAR-OLD FEMALE PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO ONGOING SHORTNESS OF BREATH. THE PATIENT HAD BEEN EXPERIENCING SYMPTOMS FOR MORE THAN 5 DAYS. IMAGING REVEALED LARGE CLOT BURDEN IN THE RIGHT ATRIUM (RA) WHICH WAS A CLOT-IN-TRANSIT (CIT). ADDITIONALLY, THE PATIENT HAD A SADDLE PULMONARY EMBOLISM (PE) IN THE MAIN PULMONARY ARTERY (MPA) AND BILATERAL PE IN THE RIGHT PULMONARY ARTERY (RPA) AND LEFT PULMONARY ARTERY (LPA). REMOVAL OF THE CIT WAS SUCCESSFUL. THE 1ST ASPIRATION YIELDED SUBSTANTIAL THROMBUS. THE PHYSICIAN INSERTED THE DILATOR AND ADVANCED THE TRIEVER24 (T24) TO ENGAGE WITH THE CLOT AND DID 2 ADDITIONAL PULLS, COMPLETELY REMOVING CLOT FROM THE RA. THE PHYSICIAN PROCEEDED TO CROSS THE RIGHT HEART AND TAKE PRESSURE MEASUREMENTS. DUE TO THE PATIENT'S PRESSURES, THERE WAS DISCUSSION ON ENDING THE CASE, BUT THE PHYSICIAN WANTED TO QUICKLY ADDRESS THE PULMONARY ARTERIES. WIRE POSITION WAS OBTAINED AND THE T24 WAS ADVANCED. THE T24 CAUSED THE WIRE TO PUSH OUT AND DUE TO THE HIGH PRESSURES, THE PHYSICIAN SWITCHED TO A TRIEVER20 (T20). THE T20 WAS ADVANCED INTO THE MPA, AND MULTIPLE ASPIRATIONS YIELDED ORGANIZED CLOT. THE PHYSICIAN THEN ADVANCED THE T20 WITHOUT THE

  Patient problems: Cardiogenic Shock; Extravasation; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 20858091 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 71-YEAR-OLD FEMALE PATIENT WITH ESOPHAGEAL CANCER WAS DIAGNOSED WITH BILATERAL PULMONARY EMBOLISM (PE) VIA COMPUTED TOMOGRAPHY ANGIOGRAPHY. THE PATIENT WAS SCHEDULED FOR THROMBECTOMY USING INARI DEVICES. THE CLOT AGE WAS ESTIMATED AT 7 DAYS. WIRE POSITIONING WAS OBTAINED WITHOUT ISSUE AND A TRIEVER20 (T20) CATHETER WAS ADVANCED INTO PLACE. AN ASPIRATION WAS PERFORMED IN THE RIGHT PULMONARY ARTERY WHICH DID NOT YIELD CLOT. THE T20 WAS ADVANCED AGAIN, AND A SECOND ASPIRATION WAS PERFORMED; HOWEVER, THE CLOT BECAME LODGED IN THE TIP OF THE T20. THE PHYSICIAN PROCEEDED TO REMOVE THE T20 CATHETER FROM THE PATIENT THROUGH THE INARI INTRI24 SHEATH. UPON INITIAL EXAMINATION, THERE WAS NO CLOT PRESENT IN THE LARGE BORE SYRINGE OR CATHETER. THE INTRI24 SHEATH WAS REMOVED UNDER PRESSURE AND FLUSHED, WHICH YIELDED A LARGE PORTION OF CLOT. THERE WAS ALSO A LARGE CLOT PRESENT AT THE ACCESS SITE WHICH WAS REMOVED MANUALLY. THE INTRI24 SHEATH AND T20 CATHETER WERE CLEANED AND ADVANCED BACK INTO PLACE WHEN THE PATIENT REPORTED EXPERIENCING DIPLOPIA IN THE LEFT EYE AND VERTIGO AND SHOWED SIGNS OF RESTLESSNESS. A RAPID RESPONSE WAS INITIATED; THE PATIENT RESPONDED TO VERBAL COMMANDS, BUT WAS UNABLE

  Patient problems: Anxiety; Stroke/CVA; Vertigo; Visual Disturbances

  MAUDE report 19169748 ↗
• InjuryFeb 1, 2024Material Fragmentation; Material Fragmentation

  A FEMALE PATIENT WITH LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) UNDERWENT A THROMBECTOMY ON (B)(6), 2024 USING THE INARI TRIEVER20 (T20). THE CLOT AGE WAS ESTIMATED AT 14 DAYS. THREE ACCESS POINTS WERE MADE IN THE RIGHT INTRAJUGULAR, LEFT POPLITEAL, AND RIGHT POPLITEAL. WIRE POSITIONING WAS OBTAINED WITHOUT ISSUE AND THE TRIEVER20 WAS ADVANCED WITHOUT AN INTRODUCER SHEATH. SEVERAL ASPIRATIONS WERE PERFORMED WHICH CLEARED THE ENTIRE CLOT FROM THE LEFT POPLITEAL VEIN. AS THE T20 CATHETER WAS BEING REMOVED, A PORTION DETACHED AND THE PHYSICIAN HALTED THE PROCEDURE TO PERFORM IMAGING. A VASCULAR SURGEON INTERVENED TO PERFORM A VENOUS CUT-DOWN TO REMOVE THE REMAINING PORTION OF THE CATHETER. ALL DEVICE FRAGMENTS WERE REMOVED SUCCESSFULLY; THE CUT-DOWN AND POPLITEAL VEINS WERE CLOSED AND A FINAL VENOGRAM WAS PERFORMED. ON (B)(6), 2024 FOLLOW-UP WAS REQUESTED FROM THE TREATING PHYSICIAN WHO REPORTED THE PATIENT WAS "DOING GREAT" POSTOPERATIVELY.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 18628534 ↗
• InjuryMar 17, 2023Retraction Problem; Activation, Positioning or Separation Problem; Retraction Problem; Activation, Positioning or Separation Problem

  A 56-YEAR-OLD FEMALE WITH DEEP VEIN THROMBOSIS (DVT) UNDERWENT A THROMBECTOMY IN THE LEFT LEG WITH THE INARI FLOWTRIEVER SYSTEM ON (B)(6) 2023. THE PATIENT ALSO HAD AN INFERIOR VENA CAVA (IVC) FILTER PLACED 90 DAYS PRIOR. THE TRIEVER20 (T20) WAS DEPLOYED AND 5 ASPIRATIONS WERE PERFORMED IN THE LEFT LEG WITH APPROXIMATELY 225 CC OF BLOOD RETURNED VIA THE INARI FLOWSAVER DEVICE TO THE RIGHT LEG (POPLITEAL ACCESS). A PENUMBRA INDIGO SYSTEM CAT 8 DEVICE WAS THEN USED TO CLEAR COLLATERAL THROMBUS. THE T20 WAS RE-INSERTED TO CLEAR THROMBUS FROM THE FEMORAL-POPLITEAL, COMMON FEMORAL, AND EXTERNAL ILIAC VEINS. HOWEVER, THE T20 BECAME CAUGHT IN THE VESSEL. THE SURGEON MADE VARIOUS ATTEMPTS TO REMOVE THE T20, INCLUDING USE OF VASODILATORS, LUBRICANTS, AND BALLOONING, BUT THE T20 WAS UNABLE TO BE REMOVED. BEFORE THE SECOND BALLOONING ATTEMPT, THE T20 SHEARED AT THE POPLITEAL ACCESS. EVENTUALLY, CARDIOTHORACIC SURGERY INTERVENED TO PERFORM A VENOUS CUTDOWN ON THE COMMON FEMORAL VEIN AND THE T20 WAS REMOVED. THE THROMBECTOMY WAS SUCCESSFUL IN REMOVING 90% OF THE CLOT BURDEN AND THE PATIENT MADE A FULL RECOVERY.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 16568390 ↗
• DeathApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR-OLD MALE PATIENT WITH A RARE BLOOD CLOTTING DISORDER PRESENTED TO THE EMERGENCY DEPARTMENT IN UNSTABLE CONDITION WITH CLOTTING ABOVE HIS EXISTING INFERIOR VENA CAVA (IVC) FILTER. THE PATIENT ALSO HAD BILATERAL DEEP VEIN THROMBOSIS (DVT) IN BOTH LEGS. THE IVC FILTER WAS PLACED 9 DAYS PRIOR AND THE PATIENT UNDERWENT SPINAL SURGERY 5 DAYS PRIOR. THE COMPUTERIZED TOMOGRAPHY (CT) SCAN DID NOT SHOW A PULMONARY EMBOLISM. ANTICOAGULANT MEDICATION HAD BEEN DISCONTINUED SINCE THE TIME OF IVC FILTER PLACEMENT AND WAS NOT REINITIATED. THE TREATMENT PLAN WAS TO USE THE INARI FLOWTRIEVER 20 (T20) TO ADDRESS CLOTTING ABOVE AND IN THE IVC FILTER AND THEN USE THE INARI CLOTTRIEVER TO ADDRESS THE DVTS IN THE LEGS. AN ECHOCARDIOGRAM WAS NOT PERFORMED PRIOR TO THE PROCEDURE. AN ACTIVATED CLOTTING TIME (ACT) TEST WAS RUN AND THE ADVISING NEUROSURGEON REQUESTED LIMITING ANTICOAGULANTS. THE PATIENT WAS INTUBATED AND PLACED ON VASOPRESSORS. A 22 FR GORE DRYSEAL SHEATH WAS PLACED IN THE NECK AND AN 8 FR SHEATH WAS PLACED IN THE LEFT POPLITEAL VEIN. TWO INTERVENTIONAL RADIOLOGISTS WERE PRESENT, THE PRIMARY PHYSICIAN WAS ASSIGNED TO TREAT THE IVC CLOT WITH THE T20 AND THE SECOND PHYSICIAN PROVI

  Patient problems: Bradycardia; Cardiac Arrest; Cardiogenic Shock; High Blood Pressure/ Hypertension; Low Oxygen Saturation

  MAUDE report 14115743 ↗
• DeathNov 24, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A (B)(6) FEMALE PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2021 WITH A BILATERAL PULMONARY EMBOLISM. THE PATIENT HAD A HISTORY OF A 3-VESSEL CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY, ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR, AND HYPERTENSION. THE PATIENT WAS ON A FLIGHT APPROXIMATELY 2.5 WEEKS PRIOR TO PRESENTING TO THE HOSPITAL; IMMEDIATELY AFTER THE INITIAL FLIGHT SHE EXPERIENCED RIGHT ANKLE EDEMA AND TENDERNESS, FOLLOWED BY SHORTNESS OF BREATH AND CHEST PAIN. THE PATIENT FLEW HOME APPROXIMATELY 7 DAYS PRIOR TO PRESENTING TO THE HOSPITAL AND SYMPTOMS HAD WORSENED. ON (B)(6) 2021 THE PATIENT UNDERWENT AN ATTEMPTED THROMBECTOMY WITH THE INARI TRIEVER20 (T20). THE SURGICAL PLAN WAS TO TREAT THE RIGHT PULMONARY ARTERY FIRST. INTERNAL JUGULAR ACCESS WAS OBTAINED VIA ULTRASOUND GUIDANCE WITH A MICRO PUNCTURE SHEATH; THE SHEATH WAS EXCHANGED WITH A STANDARD 6 FR SHEATH. THE PHYSICIAN CROSSED THE RIGHT HEART WITH A COBRA CATHETER AND A BENTSON WIRE GUIDE. WHEN CROSSING THE HEART, THE PHYSICIAN REPORTED THE COBRA CATHETER TOOK A SLIGHTLY DIFFERENT PATH THAN EXPECTED. GOOD DISTAL WIRE POSITION WAS ACHIEVED IN THE RIGHT LOWER PULMONARY ARTERY, BUT THE WIRE CONTINUED TO CREEP BACK DURI

  Patient problems: Cardiac Arrest; Cardiac Perforation; Hemoptysis; Intraoperative Pain; Loss of consciousness; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Perforation of Vessels; Pericardial Effusion; Pleural Effusion; Respiratory Arrest

  MAUDE report 12870662 ↗
• DeathApr 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AN (B)(6) YEAR-OLD MALE PATIENT WITH DIABETES AND RECENT PNEUMONIA PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2021 EXPERIENCING SHORTNESS OF BREATH FOR THE PAST 2-3 DAYS. THE PATIENT HAD SEVERE SEPSIS, HYPOXIA, HYPERTENSION, AND ELEVATED TROPONINS, AND HIS FAMILY STATED THAT THE PATIENT WAS "NOT LUCID" UPON ADMISSION. A CT SCAN REVEALED BILATERAL PULMONARY EMBOLISM (PE) THAT WAS CLASSIFIED AS HIGH-RISK SUBMASSIVE, WITH A RV/LV RATIO OF 1.2 AND CONCOMITANT DEEP VEIN THROMBOSIS (DVT) THAT DID NOT WARRANT INTERVENTION. ON (B)(6) 2021, THE INARI TRIEVER16 (T16) AND TRIEVER24 (T24) WERE USED TO ATTEMPT TO TREAT THE PE. THE PATIENT WAS PLACED ON A HEPARIN DRIP AT THE BEGINNING OF THE PROCEDURE. HIS HEART RATE WAS 84 BPM, BLOOD PRESSURE 113/66 MMHG, SPO2 98%, AND HEMOGLOBIN 13. HIS BASELINE ACT WAS 126, AND 5,000 UNITS OF HEPARIN WERE ADMINISTERED. AFTER ACCESS WAS GAINED, A SWAN-GANZ CATHETER WAS USED TO TAKE A PULMONARY ARTERY (PA) PRESSURE MEASUREMENT OF 66/26/40, INDICATING THE PATIENT HAD SEVERE PULMONARY HYPERTENSION. IMAGING CONFIRMED THE PRESENCE OF CLOT IN THE TRUNCUS ANTERIOR AND ON THE RIGHT. A 24F GORE DRYSEAL SHEATH WAS INSERTED INTO THE RIGHT COMMON FEMORAL VEIN, AND A

  Patient problems: Cardiac Arrest; Heart Failure/Congestive Heart Failure; Loss of consciousness; Low Blood Pressure/ Hypotension; Respiratory Arrest

  MAUDE report 11682925 ↗
• InjuryFeb 17, 2021Improper or Incorrect Procedure or Method

  A (B)(6) YEAR-OLD FEMALE PATIENT WITH CHRONIC PANCREATITIS PRESENTED TO THE EMERGENCY DEPARTMENT WITH HYPERTENSION AND SUSPECTED ACUTE MYOCARDIAL INFARCTION (MI). SHE WAS DIAGNOSED WITH A PULMONARY EMBOLISM (PE) AFTER UNDERGOING A RIGHT HEART CATHETERIZATION AND PULMONARY ANGIOGRAM (ACUTE MI WAS RULED OUT). ON (B)(6) 2021, THE INARI TRIEVER16 (T16), TRIEVER20 (T20), AND MEDIUM FLOWTRIEVER (FT) DISKS WERE USED TO ATTEMPT TO TREAT THE PE. THE PATIENT REMAINED HYPERTENSIVE AND TACHYCARDIC THROUGHOUT THE MECHANICAL THROMBECTOMY, WITH MARKEDLY ELEVATED RIGHT-SIDED PULMONARY AND ATRIAL PRESSURES. THE CLOT IN THE RIGHT PULMONARY ARTERY WAS SUCCESSFULLY ASPIRATED, BUT CLOT REMAINED IN THE LEFT LOWER LOBE (LLL) DESPITE USE OF THE T20, T16, AND MEDIUM FT DISKS. AN EKOS CATHETER WAS PLACED DUE TO THE PERSISTENT TACHYCARDIA, AND THE CASE WAS CONCLUDED. THE FOLLOWING DAY, RIGHT HEART CATHETERIZATION REVEALED RESOLUTION OF RIGHT VENTRICLE FAILURE AND NORMALIZATION OF RIGHT ATRIAL PRESSURE (~20 REDUCED TO ~6 MMHG). THE PATIENT'S TACHYCARDIA AND NAUSEA PERSISTED, AND THE HGB LEVEL DECREASED FROM 9 TO 7 GM/DL DUE TO 600 CC OF BLOOD BEING ASPIRATED DURING THE PROCEDURE. THE PATIENT WAS INFUSED WITH

  Patient problems: Anemia; Hematoma; High Blood Pressure/ Hypertension; Hypovolemia

  MAUDE report 11336298 ↗
• DeathJan 21, 2021Use of Device Problem; Use of Device Problem

  A (B)(6)-YEAR-OLD FEMALE PATIENT WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN ON (B)(6) 2020. SHE WAS ADMITTED TO THE CATHETERIZATION LAB, WHERE SHE UNDERWENT PERCUTANEOUS CORONARY INTERVENTION AND RECEIVED 2 CORONARY STENTS. ON (B)(6) 2020, AS THE PATIENT WAS RECOVERING FROM THE PROCEDURE, SHE BEGAN EXPERIENCING CHEST PAIN WITH SHORTNESS OF BREATH. A CT ANGIOGRAM REVEALED A SADDLE PULMONARY EMBOLISM (PE) WITH BILATERAL CLOT BURDEN. ON (B)(6) 2020, THE INARI MEDICAL TRIEVER20 (T20), TRIEVER16 (T16), AND MEDIUM FLOWTRIEVER (FT) DISKS WERE USED TO ATTEMPT TO TREAT THE PE. PRIOR TO THE CASE, IT WAS NOTED THAT THE PATIENT HAD SOME RIGHT VENTRICLE STRAIN, ELEVATED TROPONIN LEVELS, AND A HEMOGLOBIN LEVEL OF OVER 12 G/DL. AS THE CASE BEGAN, THE PATIENT'S HEART RATE WAS BETWEEN 130-150 BPM, AND BLOOD PRESSURE WAS 152/72 MMHG. ACCESS WAS GAINED VIA THE RIGHT COMMON FEMORAL VEIN, AND A BENTSON WIRE AND ANGLED PIGTAIL CATHETER WERE USED TO SUCCESSFULLY CROSS THE HEART AND ADVANCE TO THE MAIN PULMONARY ARTERY (PA); THE PA PRESSURE WAS 54/30/14 MMHG. THE WIRE WAS THEN MANEUVERED TO THE RIGHT PA AND EXCHANGED FOR A BOSTON SCIENTIFIC AMPLATZ SUP

  Patient problems: Cardiac Arrest; Hypovolemic Shock; Hypoxia; Loss of consciousness; Low Blood Pressure/ Hypotension; Oversedation; Respiratory Arrest

  MAUDE report 11211496 ↗
• DeathJan 16, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE FOLLOWING ADDITIONAL EVENT INFORMATION WAS PROVIDED TO INARI ON (B)(6), 2021. THE DAY BEFORE THE PROCEDURE, THE TEE DID NOT REVEAL ANY EVIDENCE OF A PERICARDIAL EFFUSION. ON THE DAY OF THE PROCEDURE, THE PATIENT WAS INTUBATED AND A SECOND TEE WAS PERFORMED, WHICH IDENTIFIED SOME SMALL PERICARDIAL EFFUSION; HOWEVER, THERE WAS NO SURGICAL PLAN TO TREAT AS IT WAS NOT BELIEVED TO BE SEVERE. AFTER THE CASE CONCLUDED AND THE COMPANY REPRESENTATIVE LEFT THE FACILITY, THE PATIENT EXPERIENCED WHAT WAS BELIEVED TO BE A REPERFUSION INJURY AND WAS STABILIZED ON A VENTILATOR. A BRONCHOSCOPY CONFIRMED NO SIGNS OF BLEEDING. THE PATIENT SUBSEQUENTLY DETERIORATED AND THE CAUSE OF DEATH WAS LISTED AS ACUTE SEVERE HYPOXIC RESPIRATORY FAILURE, ACUTE RIGHT VENTRICLE HEART FAILURE, AND CARDIOPULMONARY ARREST.

  Patient problems: Hemoptysis; Hypovolemia; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Pericardial Effusion

  MAUDE report 11182617 ↗
• InjuryJul 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  A (B)(6)-YEAR-OLD MALE PATIENT WITH A HISTORY LUNG CANCER WITH PRIOR CHEST IRRADIATION PRESENTED TO THE HOSPITAL IN EARLY (B)(6) 2020 WITH SYMPTOMS OF A PULMONARY EMBOLISM (PE). HEPARIN WAS ADMINISTERED, BUT THE PATIENT WAS INELIGIBLE FOR THROMBOLYTIC THERAPY (BLEEDING RISK). COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED THE PATIENT HAD BILATERAL PE. THE BASELINE VITAL SIGNS WERE: HEART RATE 95 BPM, BLOOD PRESSURE 120/73, AND O2 SATURATION 95% ON A NON-REBREATHER MASK AT 6L O2. ON (B)(6) 2020, THE INARI TRIEVER20 (T20) WAS USED TO ATTEMPT TO TREAT THE BILATERAL PE. ULTRASOUND WAS USED TO GUIDE ACCESS TO THE RIGHT COMMON FEMORAL VEIN. AN 8 FR SHEATH WAS INSERTED OVER THE GUIDEWIRE, FOLLOWED BY AN ANGLED PIG TAIL CATHETER WHICH WAS USED TO CROSS THE RIGHT HEART TO OBTAIN PULMONARY ARTERY PRESSURE (36/18). THE PIG TAIL CATHETER WAS THEN EXCHANGED FOR A BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE (260 CM), WHICH WAS ADVANCED TO THE LATERAL BRANCH OF THE LEFT LOWER LOBE. THE ACCESS SITE WAS THEN DILATED TO ACCOMMODATE A 22 FR GORE DRYSEAL SHEATH. FOLLOWING INSERTION OF THE GORE SHEATH, THE T20 WAS SUCCESSFULLY INSERTED AND ADVANCED TO THE LEFT PULMONARY ARTERY. A TOTAL OF 4 ASPIRAT

  Patient problems: Vascular Dissection

  MAUDE report 10237513 ↗
• InjuryMar 18, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A (B)(6)-YEAR-OLD FEMALE PATIENT WITH POST THROMBOTIC SYNDROME (PTS) AND CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH) WITH A HISTORY OF PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS DEVELOPED A MASSIVE PE AFTER NON-COMPLIANCE WITH THE PRESCRIBED ANTICOAGULATION MEDICATION. THE PATIENT'S VITAL SIGNS WERE: HEART RATE 88-90 BPM, BLOOD PRESSURE 120/80 MMHG, AND BLOOD OXYGENATION SATURATION 97-98%. THE PATIENT WAS ADMITTED TO THE ICU ON (B)(6) 2020 AND ON (B)(6) 2020, INARI MEDICAL'S TRIEVER20 WAS USED TO TREAT THE PE. AFTER ACCESS WAS GAINED VIA A RIGHT TRANSFEMORAL APPROACH, AN ANGLED PIGTAIL CATHETER WAS PLACED IN THE PULMONARY ARTERY. HEMODYNAMIC MEASUREMENTS INCLUDED LEFT PULMONARY ARTERY (PA) PRESSURE OF 65/16/38 (SYSTOLIC, DIASTOLIC, MEAN) MMHG, MAIN PA MEASURED 63/6/32 MMHG, AND RIGHT PA 57/14/35 MMHG. A COOK MEDICAL BENTSON 0.035" GUIDEWIRE WAS PLACED DISTALLY IN THE LOWER RIGHT LOBE, TARGETING THROMBUS IN THE RIGHT PA. THE ACCESS SITE WAS UPSIZED TO A 22 FR GORE DRYSEAL TO ACCOMMODATE THE TRIEVER20, WHICH WAS THEN ADVANCED TO THE RIGHT LOBE BEYOND THE TARGETED CLOT (SADDLE WRAPPED AROUND THE TRUNCUS ANTERIOR). THE PULMONARY ANGIOGRAM REVEALED THE CLOT MOVED DISTALL

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 9849549 ↗
• DeathMar 14, 2020Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  A (B)(6)-YEAR-OLD MALE PATIENT WITH A HISTORY OF HIGH BLOOD PRESSURE AND DIABETES WAS DIAGNOSED WITH A PULMONARY EMBOLISM (PE) WITH CLOT IDENTIFIED VIA COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY IN THE BASAL TRUNK OF THE LEFT INTERLOBAR ARTERY, AS WELL AS THE RIGHT PULMONARY ARTERY (PA) WITH CLOT EXTENDING INTO THE TRUNCUS ANTERIOR. AT BASELINE, THE PATIENT'S VITAL SIGNS WERE: HEART RATE 110 BPM, SYSTOLIC BLOOD PRESSURE APPROX. 170 MMHG, RIGHT VENTRICLE/LEFT VENTRICLE (RV/LV) RATIO 1.6, HEMOGLOBIN COUNT 15.2 GM/DL, BLOOD OXYGEN SATURATION 94% ON 2 L OXYGEN. ON (B)(6) 2020, THE INARI MEDICAL TRIEVER20 WAS USED TO TREAT THE PE. PRIOR TO PA ACCESS, THE RIGHT ATRIAL PRESSURE MEASURED 25/21/18 MMHG WHILE THE RIGHT VENTRICLE MEASURED 81/4/27 MMHG. ACCESS INTO THE PA WAS GAINED THROUGH A BALLOON TIP CATHETER WITHIN 60 SECONDS, AFTER WHICH TIME THE PA PRESSURE MEASURED 93/30/51 MMHG. AFTER EXCHANGING THE TERUMO GLIDEWIRE WITH AN AMPLATZ SUPER STIFF GUIDEWIRE THE IN RIGHT LOWER LOBE, A KINK WAS OBSERVED 7 CM FROM THE TIP. AFTER CONSULTATION, THE TEAM REALIZED A 7 CM FLOPPY TIP WAS INADVERTENTLY USED INSTEAD OF THE RECOMMENDED 1 CM, SO THIS WAS EXCHANGED FOR A 1 CM AMPLATZ SUPER STIFF GUIDEWIRE. T

  Patient problems: Death; Pericardial Effusion

  MAUDE report 9832968 ↗
• InjuryJun 10, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2019, A PATIENT WITH A HISTORY OF DEEP VEIN THROMBOSIS AND CANCER PRESENTED TO THE EMERGENCY DEPARTMENT WITH DYSPNEA; CT ANGIOGRAPHY CONFIRMED BILATERAL PULMONARY EMBOLUS. THE PATIENT WAS TRANSFERRED TO THE CATHETERIZATION LABORATORY WHERE THE INTERVENTIONAL CARDIOLOGIST GAINED ACCESS THROUGH THE GROIN USING THE INARI ASPIRATION GUIDE CATHETER (AGC) VIA ULTRASOUND AND CROSSED THE HEART. AFTER ACCESSING THE RIGHT PULMONARY ARTERY (PA), THE ACCESS GUIDEWIRE WAS EXCHANGED FOR A 0.035" TERUMO 260 CM GLIDEWIRE ADVANTAGE. A PROXIMAL THROMBUS WAS CLEARED FROM RIGHT SIDE WITH VIA ASPIRATION USING THE INARI 60 CC SYRINGE (SUPPLIED WITH THE AGC). THE INARI AGC WAS THEN REINSERTED AND PLACED INTO THE LEFT PA. THE TERUMO GLIDEWIRE WAS PLACED MID LOBE, JUST BEYOND THE CLOT BURDEN. AFTER AN UNSUCCESSFUL ASPIRATION THROUGH THE AGC, THE PATIENT HAD AN EPISODE OF SEVERE HEMOPTYSIS. THE PATIENT WAS SUBSEQUENTLY INTUBATED, BUT NO EXTRAVASATION WAS NOTED. HEPARIN WAS DISCONTINUED AND PROTAMINE WAS ADMINISTERED. THE GASTROINTESTINAL WORKUP RULED OUT STOMACH BLEEDING; BRONCHOSCOPY ON THE LEFT SIDE NOTED BLOOD IN THE AIRWAY. THE TREATING PHYSICIAN CONCLUDED THAT A MICRO VESSEL ON LEFT SIDE HAD

  Patient problems: Airway Obstruction; Hemoptysis; Perforation of Vessels

  MAUDE report 8685303 ↗
• DeathDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, A LATE-STAGE MULTIPLE MYELOMA PATIENT WITH METASTATIC CANCER PRESENTED IN THE EMERGENCY DEPARTMENT WITH DYSPNEA AND DIZZINESS. CT ANGIOGRAPHY CONFIRMED A SADDLE, BILATERAL PULMONARY EMBOLUS. HIS RIGHT VENTRICLE/LEFT VENTRICLE (RV/LV) RATIO WAS ELEVATED AT 1.5, 2L OF OXYGEN, HR: 92, BP: 112/77, AND PULMONARY ARTERY PRESSURE WAS ELEVATED AT 50/26/36 (SYSTOLIC/DIASTOLIC/MEAN MMHG). THE HISTORY OF PRIOR CHEST RADIATION WAS UNKNOWN. THE PATIENT WAS TRANSFERRED TO THE "CATHERIZATION" LABORATORY WHERE THE INTERVENTIONAL CARDIOLOGIST GAINED ACCESS THROUGH THE GROIN USING THE ASPIRATION GUIDE CATHETER (AGC) VIA ULTRASOUND AND CROSSED THE HEART WITH A PIGTAIL CATHETER. HEMODYNAMIC MEASUREMENTS AND PULMONARY ANGIOGRAPHY REVEALED A PROXIMAL THROMBUS IN THE TRUNCUS ANTERIOR AND MIDDLE LOBAR SEGMENTS. BLOOD PRESSURE BECAME UNSTABLE. THE PIGTAIL CATHETER WAS REPLACED WITH THE AMPLATZ SUPERSTIFF GUIDEWIRE. STARTING IN THE RIGHT PULMONARY ARTERY (PA), AN ACUTE/CHRONIC CLOT WAS EXTRACTED VIA ASPIRATION WITH THE 60 CC SYRINGE (SUPPLIED AS PART OF THE AGC SYSTEM). THE TRUNCUS ANTERIOR WAS OBSTRUCTED, PREVENTING GUIDEWIRE ACCESS. THE AGC WAS REINSERTED AND PLACED INTO THE LEFT PA, BUT N

  Patient problems: Death; Hemoptysis

  MAUDE report 8197150 ↗
• DeathDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT PRESENTED IN THE EMERGENCY DEPARTMENT WITH A CLOT IN THE LUNGS. CT ANGIOGRAPHY CONFIRMED A SADDLE, BILATERAL PULMONARY EMBOLUS WITH ALMOST COMPLETE OBSTRUCTION OF THE RIGHT PULMONARY ARTERY (PA). THE FOLLOWING DAY THE PATIENT BEGAN DECOMPENSATING IN THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) THEN STABILIZED; RIGHT VENTRICLE/LEFT VENTRICLE (RV/LV) RATIO WAS ELEVATED AT 2.1, SAO2: 92 (ON 15L OF OXYGEN), HR: 105, BP: 116/71, AND PULMONARY ARTERY PRESSURE WAS ELEVATED 69/27/41 (SYSTOLIC/DIASTOLIC/MEAN MMHG). IT SHOULD BE NOTED THAT WHILE THE PATIENT HAD BEEN ON 15L OF OXYGEN IN THE CVICU, THIS WAS DECREASED TO 4L VIA NASAL CANNULA DURING THE THROMBECTOMY PROCEDURE WHICH MAY HAVE PREDISPOSED THE FOLLOWING HYPOXEMIC EVENT. THE PHYSICIAN GAINED ACCESS USING THE ASPIRATION GUIDE CATHETER (AGC) VIA ULTRASOUND AND CROSSED THE HEART WITH A BALLOON-TIPPED CATHETER. HEMODYNAMIC MEASUREMENTS AND PULMONARY ANGIOGRAPHY REVEALED A SUBSTANTIAL CLOT IN THE RPA (NO ANGIOGRAPHY OF THE LEFT PULMONARY ARTERY AT THIS TIME). THREE VACUUM ASPIRATIONS USING THE 60 CC SYRINGE (SUPPLIED AS PART OF THE AGC SYSTEM) RETRIEVED SUBSTANTIAL CLOT WITH EACH ATTEMPT; BLOOD LOSS WAS 20 CC

  Patient problems: Death

  MAUDE report 8146445 ↗
• InjuryAug 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FLOWTRIEVER PROCEDURE WENT VERY WELL. THE INARI ASPIRATION GUIDE CATHETER, 21-101, WAS INSERTED THROUGH A PRE-PLACED 22 FR GORE DRYSEAL INTRODUCER SHEATH. SMALL (10-101) AND A MEDIUM (10-102) FLOWTRIEVER CATHETERS WERE USED ON THE LEFT PULMONARY ARTERY TO REMOVE CLOT. AT THE END OF THE PROCEDURE, THE SHEATH WAS PULLED AND A CATH LAB TECH HELD PRESSURE AT THE GROIN. WHEN THE PATIENT LEFT THE CATH LAB THE ACCESS SITE WAS CLEAN AND DRY. THREE DAYS AFTER DISCHARGE THE PATIENT REPORTED SWELLING AT THE ACCESS SITE AND RETURNED TO THE HOSPITAL. DUE TO THE HEMATOMA THAT FORMED, THE DECISION WAS MADE TO SURGICALLY CLOSE THE ACCESS SITE.

  Patient problems: Hematoma

  MAUDE report 6806535 ↗