EKOSONIC ENDOVASCULAR CATHETER
Report
- Report Number
- 3001627457-2016-00011
- Event Type
- Death
- Date Received
- April 15, 2016
- Date of Event
- January 29, 2016
- Report Date
- March 17, 2016
- Manufacturer
- EKOS CORPORATION
- Product Code
- KRA
- PMA / PMN Number
- K140151
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE CAUSE OF THE SEVERE EPISTAXIS IN THIS PATIENT, WHICH LED ON TO ASPIRATION PNEUMONIA, ARDS AND SUBSEQUENT COMPLICATIONS, HAS NOT BEEN FULLY ELUCIDATED. IT IS KNOWN THAT THE PATIENT EXPERIENCED A DROP IN PLATELETS BETWEEN (B)(6) 2015, BUT A HIT PANEL WAS NEGATIVE AROUND THAT TIME. THE ROLE OF THROMBOLYSIS IN THIS CHAIN OF EVENTS CANNOT BE EXCLUDED, AND THEREFORE, PER PROTOCOL, GIVEN THAT THIS OCCURRED WITHIN 24 HOURS OF EKOS THERAPY, IT IS CONSIDERED TO BE A REPORTABLE EVENT. IT DOES NOT ALTER THE BENEFIT RISK ASSESSMENT OF THE PRODUCT AT THE PRESENT TIME; FURTHER FOLLOW-UP IS EXPECTED. NO MALFUNCTION OF THE EKOSONIC DEVICE WAS REPORTED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER THEREFORE NO EVALUATION OR INVESTIGATION OF THE DEVICE COULD BE PERFORMED.
NO MALFUNCTION OF THE EKOSONIC DEVICE WAS REPORTED. NO PATIENT INJURY RELATED TO THE EKOSONIC DEVICE WAS REPORTED. NO DEVICE WAS RETURNED TO EKOS FOR EVALUATION, THEREFORE, NO DEVICE INVESTIGATION WAS POSSIBLE.
CORRECTED REPORT DATE TO 03/17/2016.
THIS IS A FOLLOW UP CLINICAL REPORT FROM (B)(6). ACCESS PTS IS A PROSPECTIVE, SINGLE ARM, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY OF ULTRASOUND ACCELERATED THROMBOLYSIS USING THE EKOSONICENDOVASCULAR SYSTEM WITH STANDARD INFUSION OF THROMBOLYTIC DRUG FOR POST-THROMBOTIC SYNDROME AND CHRONIC VENOUS OCCLUSION. THE REPORT CONCERNS (B)(6), A (B)(6) FEMALE OF CAUCASIAN (NON-HISPANIC) ETHNIC ORIGIN WITH (B)(6) WHO EXPERIENCED ACUTE DVT, SEVERE EPISTAXIS, ASPIRATION PNEUMONITIS, ACUTE RESPIRATORY INSUFFICIENCY, SEPTIC SHOCK, FOLLOWING STUDY TREATMENT WITH EKOSONIC DEVICES AND THROMBOLYTIC DRUG (ALTEPLASE) THE PATIENT'S MEDICAL HISTORY INCLUDED ASTHMA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), SLEEP APNOEA, HISTORIC TOBACCO USE, OSTEOARTHRITIS, FIBROMYALGIA, IBS, RESTLESS LEGS, GASTROESOPHAGEAL REFLUX DISEASE (GERD), AND HYPOTHYROIDISM. THE PATIENT ALSO HAD THE FACTOR V LEIDEN MUTATION HYPERCOAGULABLE ABNORMALITY. SHE HAD EXPERIENCED A MASSIVE PULMONARY EMBOLISM IN 2007 RESULTING IN THE FITTING OF AN INFERIOR VENA CAVA FILTER. SHE ALSO EXPERIENCED DVT IN BOTH LEGS ON (B)(6) 2007, WHICH RESOLVED TWO DAYS LATER. SHE THEN DEVELOPED A FURTHER CHRONIC DVT IN HER LEFT LEG ON (B)(6) 2008 (RECOVERING ON (B)(6) 2012) AND A DVT IN HER RIGHT LEG ON (B)(6) 2012, LASTING 15 DAYS. SHE HAD STENTS IN THE VENA CAVA, GROIN AND LEFT LEG. THE PATIENT HAD NO HISTORY OF HYPERCHOLESTEROLAEMIA, CONGESTIVE HEART FAILURE, RENAL OR HEPATIC INSUFFICIENCY, TIA OR STROKE, CANCER, DIABETES, HYPERTENSION, ATHEROSCLEROTIC CARDIOVASCULAR DISEASE AND HAD NOT EXPERIENCED ACUTE INFECTIOUS ILLNESS WITHIN 30 DAYS OF CONSENTING TO THE STUDY BUT HAD A PERVIOUS 6 DAY HOSPITALISATION WITH PNEUMONIA. THE PATIENT HAD DRUG ALLERGIES TO DULOXETINE AND MELOXICAM. PRIOR TO ADMISSION FOR STUDY TREATMENT, THE SUBJECT WAS DISCONTINUED FROM WARFARIN ON (B)(6) 2015 AND BRIDGED TO ENOXAPARIN (LOVENOX) 120MG/0.8ML SYRINGE, 1 SYRINGE TO BE INJECTED EVERY 12 HOURS WHEN DIRECTED AROUND TIME OF PROCEDURE, PER PROTOCOL. HER ADDITIONAL PRE-ADMISSION MEDICATIONS INCLUDED ALBUTEROL SULFATE INHALER (PRN), ORAL ASCORBIC ACID, ORAL ASPIRIN, FLUTICASONESALMETEROL (ADVAIR DISKUS) 500-50MCG/DISC INHALER, ORAL FUROSEMIDE (LASIX), ORAL GLUCOSAMINE-CHONDROITIN, ORAL MILNACIPRAN (SAVELLA) 1 50MG TABLET BD, ORAL MONTELUKAST, ORAL OMEPRAZOLE (PRILOSEC) 2 DF DAILY, ORAL POTASSIUM CHLORIDE, ORAL PREGABALIN (LYRICA) 150MG 1 CAPSULE BD, ORAL RANITIDINE HCL (ZANTAC) 2 DF DAILY, TIOTROPIUM BROMIDE INHALER, ORAL ERGOCALCIFEROL (DRISDOL) 50,000IU 1 CAPSULE WEEKLY FOR 12 WEEKS, FLUTICASONE (FLONASE) 50MCG/ACTUATION NASAL SPRAY, ORAL METAXALONE (SKELAXIN) 800MG TABLETS, 400-800MG PRN, ORAL ROPINIROLE, LEVOTHYROXINE (SYNTHROID). ON (B)(6) 2015 THE PATIENT WAS ADMITTED TO HOSPITAL AND UNDERWENT SCREENING WITH LIMB ASSESSMENT PRIOR TO THE COMMENCEMENT OF THE EKOSONIC PLACEMENT PROCEDURE. THE PATIENT'S VITALALTA POST THROMBOTIC SYNDROME SCORES WERE 8 FOR THE RIGHT LEG AND 5 FOR THE LEFT. THE PATIENT HAD MILD PAIN IN RIGHT LEG (MODERATE UNDER CALF COMPRESSION) WITH MODERATE HEAVINESS AND SEVERE PARESTHESIA. THE LEFT LEG SHOWED MILD PAIN (MILD UNDER CALF COMPRESSION), MODERATE HEAVINESS AND MILD PRURITUS. VENOUS CLINICAL SEVERITY SCORE WAS 6 FOR THE RIGHT LEG AND 4 FOR THE LEFT, WITH THE PATIENT'S LEGS BEING SYMPTOMATIC OF VENOUS DYSFUNCTION WITH THE RIGHT LEG CAUSING MODERATE PAIN, WITH MILD VARICOSE VEINS AND EDEMA WITHOUT SKIN CHANGES. THE LEFT LEG HAD MILD VARICOSE VEINS AND BOTH LEGS WERE UNDER SEVERE COMPRESSION THERAPY. PRE-PROCEDURE LABS: RBC 5.03 MILLION/UL, WBC 6.1 THOUSAND/UL, HAEMOGLOBIN 14.7 G/DL, HEMATOCRIT 44.8%, PLATELETS 180 THOUSAND/UL, SERUM CREATININE 0.56 MG/DL, INR 1.1. INDEX PROCEDURE COMMENCED AT 09:40 ON THE MORNING OF ADMISSION. RIGHT LOWER EXTREMITY VENOGRAM DEMONSTRATED SEVERE LONG SEGMENT STENOSIS OF THE RIGHT FEMORAL VEIN AND MULTI-FOCAL SEVERE STENOSIS OF THE RIGHT BK AND AK POPLITEAL VEIN. BALLOON ANGIOPLASTY OF THE RIGHT AT VEIN (6MM), RIGHT BK POPLITEAL VEIN (8MM), RIGHT FEMORAL VEIN (8 AND 10MM) AND RIGHT COMMON FEMORAL VEIN (12MM) WAS PERFORMED. POST-ANGIOPLASTY RIGHT VENOGRAPHY DEMONSTRATED SIGNIFICANT IMPROVEMENT IN VENOUS DRAINAGE. THE ACCESS SITES USED FOR TREATMENT WERE THE RIGHT JUGULAR AND RIGHT POPLITEAL VEIN, WITH ONE EKOSONIC DEVICE POSITIONED IN THE RIGHT COMMON, RIGHT PROXIMAL AND RIGHT DISTAL FEMORAL VEIN 30CM TREATMENT ZONE, AND ANOTHER IN THE RIGHT POPLITEAL VEIN 18CM TREATMENT ZONE OF THE PATIENT'S RIGHT LEG. THE THROMBOLYTIC INFUSION WITH DETAILS STARTED AT 12:08, THE PLACEMENT PROCEDURE ENDED AND ULTRASOUND STARTED AT 12:35. THE THROMBOLYTIC INFUSION CONTINUED AT 0.5MG/HR PER CATHETER AND DELIVERED A TOTAL DOSE OF 28.6MG OVER 25.5 HOURS WITH CONCURRENT ULTRASOUND. THE TOTAL DOSE OF ALTEPLASE ADMINISTERED WAS 28.6MG. UNFRACTIONATED HEPARIN WAS INFUSED THROUGH POPLITEAL SHEATH AT 600 U/HR. NO ADVERSE EVENTS OR BLEEDING EVENTS WERE OBSERVED DURING THE PROCEDURE. ON (B)(6) 2015, THE PATIENT DESCRIBED SEVERE HEADACHE OVERNIGHT, RESOLVING WITH TYLENOL AND OXYCODONE THERAPY. THE PATIENT WAS ALSO OBSERVED TO HAVE A SIGNIFICANT DROP OF PLATELETS OVERNIGHT (FROM 180,000 TO 115,000) WITH SUSPECTED RELATIONSHIP TO ANTICOAGULATION OR HEPARIN INDUCED THROMBOCYTOPENIA (HIT). THE PATIENT DISCONTINUED HEPARIN AND RESUMED LOVENOX. OOZING AROUND NECK ACCESS SITE AND SMALL AMOUNT FROM RIGHT LEG WERE OBSERVED WITH THE PHYSICIAN NOTING A SMALL AMOUNT OF DRIED BLOOD AROUND ENTRY SITES. NO APPRECIABLE HEMATOMA OR ACTIVE BLEEDING WAS RECOGNIZED. EKOS TREATMENT ENDED AT 13:36. AT 14:15, VENOGRAM POST-EKOS THERAPY SHOWED PATENCY WITH FLOW FROM THE RIGHT COMMON FEMORAL TO THE CAUDAL POPLITEAL VEIN. SUBJECT WAS TREATED WITH ADJUNCTIVE TREATMENT OF PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). SUBSEQUENT VENOGRAM OF RIGHT LOWER EXTREMITY DEMONSTRATED PATENCY OF FLOW, NO OCCLUSION OR STENOSIS WITH DECREASED COLLATERALS AND NO EXTRAVASATION. POST- EKOS ADJUNCTIVE TREATMENT ENDED AT 16:20 AND ALL CATHETERS, WIRES, SHEATHS WERE REMOVED. RIGHT NECK WAS CLOSED WITH PURSE STRING SUTURE AND STERILE DRESSING APPLIED. NO COMPLICATIONS WERE REPORTED. NURSE LATER NOTED BLEEDING AT POPLITEAL SITE WHEN AIR WAS RELEASED FROM SAFEGUARD. SAFEGUARD REINFLATED WITH AIR (50 CC) AND PRESSURE HELD. IT WAS RECOMMENDED TO CONTINUE ANTICOAGULATION WITH LOVENOX 100 MG BID UNTIL SEEN AT 30 DAY FOLLOW-UP VISIT, BUT THE PATIENT'S EVENING DOSE OF LOVENOX WAS HELD. AT 02:50 ON (B)(6) 2015, A CONTINUED DROP IN PLATELETS TO 90,000 WAS NOTED. THE MORNING DOSE OF LEVENOX WAS ADMINISTERED AND THE PATIENT DID NOT REPORT ANY COMPLAINTS. DUPLEX ULTRASOUND AT 08:26 SHOWED EVIDENCE OF TOTALLY OCCLUDING ACUTE DVT IN THE RIGHT FEMORAL TO POPLITEAL VEIN. THE PATIENT WAS TAKEN TO OR FOR REVASCULARIZATION PROCEDURE FOR ACUTE-ON-CHRONIC DVT OF RIGHT LOWER EXTREMITY. THE PATIENT WAS SEDATED DUE TO ANXIETY. NASAL TRUMPET WAS PLACED IN SUBJECT'S LEFT NARE AND RESULTED IN MILD BLEEDING. ARGATROBAN DRIP (25 MG BOLUS) FOLLOWED BY 20MCG/KG/MIN WAS INITIATED AND SUBJECT EXPERIENCED SEVERE EPISTAXIS RESULTING IN AIRWAY COMPROMISE AND OXYGEN DESATURATION WITH 10 MINUTE PERIOD OF SPO2 IN THE 80'S AND A 5 MINUTE PERIOD OF SPO2 IN THE 60S. SUBJECT WAS INTUBATED DUE TO AIRWAY COMPROMISE AND O2 DESATURATION. ARGATROBAN WAS TEMPORARILY DISCONTINUED. LEFT NARE BLEED TREATED WITH 7.5 CM RHINO ROCKET, SURGIFLO HEMOSTATIC THROMBIN-BASED AGENT AND 9.0 CM RHINO ROCKET. SIGNIFICANT BLEEDING STOPPED. VENOGRAM AND IVUS DEMONSTRATED COMPLETE THROMBOSIS OF THE RECANALIZED SEGMENT FROM ROSTRAL FEMORAL VEIN TO BELOW KNEE POPLITEAL VEIN AND THE PATIENT UNDERWENT RIGHT FEMOROPOPLITEAL VEIN ANGIOJET THROMBOLYSIS/THROMBECTOMY WITH 20MG TPA, THEN 10MM BALLOON ANGIOPLASTY. POST ANGIOPLASTY VENOGRAPHY DEMONSTRATED MILD STENOSIS. THE PATIENT REMAINED INTUBATED AND SEDATED AND WAS ADMITTED TO CVICU POSTOPERATIVELY FOR ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AND SEPSIS AFTER BECOMING TACHYCARDIC AND FEBRILE AND DESATURATED INTO THE LOW 90'S, REQUIRING 100% FIO2. AT AN UNREPORTED TIME ON (B)(6) 2015 THE PATIENT RECEIVED A BOLUS OF 3L FLUID. ON (B)(6) 2015 AT 04:00 THE PATIENT WAS SEDATED WITH MIDAZOLAM AND UNDERWENT A NON-TUNNELLED CV CATHETER INSERTION TO THE LEFT INTERNAL JUGULAR FOR VASCULAR ACCESS AND CENTRAL PRESSURE MONITORING. THE PROCEDURE WAS PERFORMED UNDER FENTANYL ANAESTHESIA. PLACEMENT WAS VERIFIED BY X-RAY AND BLOOD RETURN WAS SEEN THROUGH ALL PARTS. NO PNEUMOTHORAX WAS OBSERVED ON X-RAY. AT 06:00 THE PATIENT'S PULSE WAS 115 AND RESPIRATION RATE WAS 14. ECCHYMOSIS AND SWELLING (NO BLEEDING) WAS OBSERVED AROUND THE RIGHT INTERNAL JUGULAR PUNCTURE SITE. THE PATIENT WAS DIAGNOSED WITH ASPIRATION PNEUMONIA LEADING TO SEPTIC SHOCK. BROAD SPECTRUM ANTIBIOTICS (FLAGYL, CEFEPIME AND VANCOMYCIN) WERE INITIATED. A BRONCHOSCOPY DEMONSTRATED PREDOMINANTLY ASPIRATED BLOOD. TREATMENT WITH NOREPINEPHRINE WAS STARTED. AT 09:45 IT WAS NOTED THAT THE PATIENT WAS ACIDOTIC WITH ACUTE BLOOD LOSS ANAEMIA, ACUTE KIDNEY INJURY, ACUTE RESPIRATORY DISTRESS SYNDROME, COAGULOPATHY, ELECTROLYTE ABNORMALITIES, HYPOTENSION, PNEUMONIA, AND SEPTIC SHOCK. CRITICAL CARE PROVIDED INCLUDED ANTIBIOTICS, FLUID ADMINISTRATION, INVASIVE HAEMODYNAMIC MONITORING, MANAGEMENT OF MECHANICAL VENTILATION, SEDATION MANAGEMENT AND TITRATION OF VASOPRESSOR INFUSIONS. AT 06:32 ON (B)(6) 2015, THE PATIENT WAS NEGATIVE FOR HIT ANTIBODIES. SHE HAD ACUTE KIDNEY INJURY (AKI) WITH POOR URINARY OUTPUT OVERNIGHT AND UPTRENDING BUN AND CREATININE TO 2.67. MUDDY BROWN CASTS WERE OBSERVED ON URINALYSIS AND THE PATIENT WAS HEADING TOWARDS REQUIRING CRRT. THE PATIENT WAS PLACED ON AND ELECTROLYTES PROTOCOL. THERE WAS CONCERN FOR ASPIRATION GIVEN THE IMAGING, LEUCOCYTOSIS AND RESPIRATORY DISTRESS. THE PATIENT HAD AN EPISODE OF FEVER BUT HAD DOWNTRENDING LEUCOCYTOSIS. ON (B)(6) 2015, THE PATIENT'S CREATININE LEVEL WAS IN CONTINUED UPTREND (4.16, LATER 5.56) AND SHE WAS STARTED ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) FOR AKI ON (B)(6) 2015. ARGATROBAN WAS DISCONTINUED ON (B)(6) 2015 AND THE PATIENT TRANSITIONED TO HEPARIN. PLATELETS DECREASED TO 120,000, WITH NO NOTED BLEEDING. NASAL PACK REMOVED ON (B)(6) 2015. SUBJECT UNDERWENT TRACHEOSTOMY ON (B)(6) 2016. NEURO/PSYCH DIFFERENTIAL DIAGNOSIS ON (B)(6) 2016 INCLUDED SUBACUTE ANOXIC BRAIN INJURY NOT VISUALIZED ON MRI VS. CONTINUED HYPOACTIVE DELIRIUM. ON (B)(6) 2016, PERSISTENT AKI WAS TREATED WITH INTERMITTENT HEMODIALYSIS (IHD). AKI WAS NOTED AS SECONDARY TO ACUTE TUBULAR NECROSIS (ATN) FROM HYPOTENSION/SEPTIC SHOCK. THE PATIENT RECEIVED TRANSFUSION OF 1 UNIT OF PRBCS FOR HEMATOCRIT OF 19 ON (B)(6) 2016. ON (B)(6) 2016, TUNNELED CATHETER WAS PLACED FOR CONTINUED IHD AND SEPTIC SHOCK WITH HYPOTENSION RESOLVED. THE PATIENT'S MENTAL STATUS WAS NOTED AS SIGNIFICANTLY IMPROVED ON (B)(6) 2016. ADDITIONAL TRANSFUSIONS OF 1 UNIT OF PRBCS EACH WERE GIVEN ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED TO A LONG TERM CARE FACILITY TO UNDERGO FURTHER WEANING. ON (B)(6) 2016 THE PATIENT WAS ADMITTED TO ICU IN CRITICAL CONDITION FOR RESPIRATORY FAILURE, ON HIGH PRESSURE VENTILATION. SHE RECEIVED DIALYSIS AND THERE WAS NOTED BLEEDING FROM TRACHEOSTOMY SITE WITH ASPIRATION OF BLOOD INTO THE AIRWAY CAUSING DIFFICULTY IN OXYGENATION, HYPOXIA AND A LARGE AMOUNT OF BLOOD CLOTS. THE PATIENT CHEST X-RAY SHOWED INFILTRATES BILATERALLY IN UPPER LOBES. ON (B)(6) 2016 THE PATIENT DESATURATED (98% TO 90%) AND COUGHED BLOOD. CODE WAS CALLED AT 02:00 AND CPR WAS PERFORMED UNTIL 02:25. TRACHEOSTOMY WAS REMOVED AND THE PATIENT WAS INTUBATED. SHE WENT INTO SEPTIC SHOCK. HEMOGLOBIN 8; HEMATOCRIT 28, PLATELET 165,000, CREATININE 2.5. BRONCHOSCOPY NOTED FREE FLOATING TISSUE AND BLOOD AT DISTAL END OF ET TUBE LEADING TO OCCLUSION. THE PATIENT WAS EXTUBATED TO ROOM AIR PER FAMILY DIRECTIVE AT 12:15. ASYSTOLE NOTED WITH NO AUDIBLE HEART TONES OR PULSES PRESENT. THE TIME OF DEATH WAS PRONOUNCED AT 12:40.
THE PATIENT, A (B)(6) FEMALE OF CAUCASIAN (NON-HISPANIC) ETHNIC ORIGIN, WAS TREATED FOR DVT WITH THE EKOSONIC DEVICE, BEGINNING ON (B)(6) 2015. ACCORDING TO THE TREATING PHYSICIAN, THE PATIENT TOLERATED THE PLANNED EKOS TREATMENT WELL (B)(6) 2015. THE EKOSONIC SYSTEM FUNCTIONED AS EXPECTED WITH NO PATIENT INJURY OR DEVICE MALFUNCTION. BEGINNING ON MORNING OF (B)(6) 2015, PATIENT EXPERIENCED UNEXPECTED DROP IN PLATELETS SO PHYSICIAN CHOSE TO TREAT THE PATIENT CONSERVATIVELY BY HOLDING HEPARIN AND STARTING ARGATROBAN DUE TO POTENTIAL FOR HEPARIN INDUCED THROMBOCYTOPENIA (HIT). THE TREATED VESSEL RE-THROMBOSED ON (B)(6) 2015 WHILE THE PATIENT WAS STILL IN THE HOSPITAL. PATIENT WAS TREATED FOR RE-THROMBOSIS WITH ANGIOJET ON (B)(6) 2015. SEDATION WAS REQUIRED FOR ANGIOJET PROCEDURE AND PATIENT EXPERIENCED TRAUMATIC MECHANICAL INJURY FROM PLACEMENT OF NASAL TRUMPET WHICH LED TO UNCONTROLLED EPISTAXIS WITH ASPIRATION OF BLOOD INTO THE LUNGS. THE PHYSICIAN BELIEVES THAT ASPIRATION PNEUMONIA ULTIMATELY LEAD TO MULTIPLE ORGAN FAILURE AND DEATH ON (B)(6) 2016, MORE THAN 30 DAYS AFTER EKOS TREATMENT. THE PATIENT'S DEATH WAS REPORTED TO EKOS (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237145 | EKOSONIC ENDOVASCULAR CATHETER | CATHETER, CONTINUOUS FLUSH | KRA | EKOS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death |