ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
Report
- Report Number
- 3002808486-2022-00913
- Event Type
- Death
- Date Received
- August 3, 2022
- Date of Event
- June 15, 2022
- Report Date
- January 5, 2023
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002448695
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURERS REF# (B)(4). PMA/510(K) NUMBER SIMILAR TO DEVICE MARKETED UNDER: PMA/510(K): P140016 INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT WAS OPENED TO ADDRESS TYPE IA ENDOLEAK BASED ON PROVIDED INFORMATION AND FINDINGS IN IMAGING REVIEW FOR (B)(4) (TYPE III ENDOLEAK THAT COVERS ZTA-PT-40-36-217 AND ZTA-34-161-W1 RESPECTIVELY). ON (B)(6) 2022 A 87 YEAR-OLD MALE PATIENT UNDERWENT AN EMERGENCY TREATMENT FOR A RUPTURED DISSECTING ANEURYSM (DAA), WHERE A ZTA-P-34-161-W1 WAS PLACED FIRST DISTALLY AND THEN ZTA-PT-40-36-217-W1 (COMPLAINT DEVICE) WAS PLACED PROXIMALLY. THE PHYSICIAN FIRST INSERTED THE ZTA-P-34-161-WI COMPONENT WITH A DISTAL LANDING ZONE ON 4 CM ENSURED FROM THE ANEURYSM OF THE DESCENDING THORACIC AORTA AND THEN ZTA-PT-40-36-217-W1 WAS PLACED PROXIMALLY WITH THE PROXIMAL SIDE OF THE STENT GRAFT TO BARELY COVER THE LEFT CAROTID ARTERY. AT COMPLETION OF THE TEVAR PROCEDURE A TYPE IA ENDOLEAK (B)(4) WAS OBSERVED ON ANGIOGRAM BUT NO OBVIOUS BLOOD LEAKAGE TO THE OUTSIDE OF THE ANEURYSM WAS OBSERVED. ANEURYSMAL ENLARGEMENT OF THE ASCENDING AORTA AND AORTIC ARCH WAS ALSO OBSERVED SO THE PHYSICIAN PLANNED TO REPLACE THE AORTIC ARCH BY SUTURING THIS SITE TOGETHER WITH THE PROXIMAL STENT GRAFT (ZTA-PT-40-36-217-W1). THE ZTA-PT-40-36-217-W1 STENT WAS TRIMMED TO FIT THE DISTAL ANASTOMOTIC SITE AND FIXED AT 4 POINTS WITH THE AORTIC WALL (USING 4-0PROLENE). THEN IT WAS WRAPPED WITH FELT AND SAWED TO THE TRIPLEX VASCULAR GRAFT. THE LEFT COMMON CAROTID ARTERY AND BRACHIOCEPHALIC TRUNK WERE ANASTOMOSED TO THE TRIPLEX. THE BASE OF THE AORTA WAS CUT SLIGHTLY PROXIMAL TO THE STJ (SINOTUBULAR JUNCTION) AND IT WAS STITCHED TO THE PROXIMAL PART OF THE TRIPLEX VASCULAR GRAFT. A FUSION GRAFT CONNECTED TO THE LEFT AXILLARY ARTERY WAS ANASTOMOSED TO THE REMAINING ONE BRANCH OF THE TRIPLEX. UPON COMPLETION OF THE PROCEDURE THE PATIENT BECAME HYPOTENSIVE AND BLEEDING INTO THE LEFT THORACIC CAVITY OCCURRED, AND A SEARCH REVEALED THAT THE BLEEDING FROM THE RUPTURED HOLE OF THE ANEURYSM RECURRED. AN ATTEMPT WAS MADE TO CLOSE THE RUPTURE HOLE, BUT THE TISSUE WAS EXTREMELY FRAGILE AND DIFFICULT TO ANASTOMOSE, AND THEY HAD TO PERFORM LEFT CHEST OPENING AND PUT THE PATIENT BACK ON EXTRACORPOREAL CIRCULATION. WHEN THE AORTA WAS INCISED, THERE WAS (TYPE II) ENDOLEAK FROM THE INTERCOSTAL ARTERY (B)(4) AND TYPE III ENDOLEAK (B)(4) FROM THE SUTURE HOLES OF THE STENT GRAFTS. THE INTERCOSTAL ARTERY WAS, STITCHED TO STOP BLEEDING AND THE DISTAL STENT GRAFT WAS REMOVED AND REPLACED BY A TRIPLEX 1-BRANCHED DEVICE. THE PROXIMAL STENT GRAFT WAS ALSO REMOVED AND REPLACED WITH A NON-COOK DEVICE. THE PHYSICIAN MANAGED TO CONTROL BLEEDING FROM BLOOD VESSELS SUCH AS THE ANASTOMOSIS SITE OF LARGE VESSEL AND THE INTERCOSTAL ARTERY, BUT IT WAS DIFFICULT TO CONTROL OOZING FROM THE INCISION SITE, CHEST WALL, ETC., AND THE PATIENT BECAME HYPOTENSION GRADUALLY DUE TO *ANA DUE TO LONG-TERM EXTRACORPOREAL CIRCULATION AND CARDIAC ARREST AND VA ECMO (VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION) WAS ATTACHED. AN EXPLORATORY LAPAROTOMY WAS ALSO PERFORMED AND FOUND SEVERE EDEMA IN THE INTESTINAL TRACT, BUT NO ISCHEMIA WAS OBSERVED. THE OPERATION WAS ENDED WITH THE ABDOMEN AND CHEST OPEN, AND THE PATIENT ADMITTED TO ICU. AT ICU THE PATIENT RECEIVED MULTIPLE BLOOD COMPONENT TRANSFUSIONS DUE TO BLEEDING AROUND THE GRAFT AND IN THE THORACIC CAVITY, BUT THE BLEEDING WAS UNCONTROLLABLE RESULTING IN ACEDEMIA, AND DIC AND THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2022. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. A PREOPERATIVE CT STUDY AND ANGIOGRAM WERE PROVIDED AND IMAGING REVIEW HAS BEEN PERFORMED BY AN IMAGING EXPERT. PER THE FINDINGS IN THE IMAGING REVIEW: ¿THE CT STUDY, DATED 6/14/22, SHOWS A TYPE 2 AORTIC ARCH WITH ANEURYSMAL DILATION OF THE ASCENDING AORTA TO A MAXIMUM DIAMETER OF 55 X 53 MM. THE AORTIC ARCH DIAMETER IS 42 X 40 MM AT THE INNOMINATE TRUNK, 40 X 39 MM AT THE LCCA, AND 44 MM AT THE LSA (15 MM DISTAL TO THE LCCA LANDING ZONE). A DESCENDING THORACIC AORTIC ANEURYSM BEGINS IMMEDIATELY DISTAL TO THE LSA WITH A MAXIMUM DIAMETER OF 72 X 66 MM IN THE PROXIMAL DESCENDING TA. THE ANEURYSM TERMINATES AND THE AORTIC DIAMETER REDUCES TO 29-31 MM AT THE MID DESCENDING TA. FINAL ANGIOGRAM SHOWS A PATENT ENDOGRAFT WITH PATENT INNOMINATE AND LEFT COMMON CAROTID ARTERIES. A TYPE 1A ENDOLEAK IS SEEN AROUND THE PROXIMAL GRAFT WITH FAINT PERFUSION OF THE LSA¿. THE IMAGING REVIEWER COMMENTS THAT THE PATIENT¿S PROXIMAL NECK ANATOMY IS OUTSIDE OF IFU: ¿PREOP IMAGING SHOWS A PROXIMAL NECK UNSUITABLE FOR ENDOVASCULAR REPAIR ALONG WITH DILATION OF THE ASCENDING AORTA AND AORTIC ARCH. THE PROXIMAL NECK DIAMETER IS 40 MM AT THE LCCA LANDING ZONE AND 44 MM AT THE LSA (15 MM FROM THE LCCA). THIS ANATOMY IS OUTSIDE THE IFU FOR THIS DEVICE, THUS REQUIRING THE SUBSEQUENT AORTIC ARCH REPLACEMENT TO COMPLETE THE REPAIR¿. A CLINICAL ASSESSMENT HAS BEEN PERFORMED BY A MEDICAL ADVISOR. AS PER CLINICAL ASSESSMENT, FOLLOWING COMMENTS WERE NOTED: ¿THIS IS AN EMERGENCY CASE WHERE A PATIENT WAS TREATED FOR AORTIC RUPTURE (OUTSIDE INDICATION) WITH TWO PROXIMAL ZTA STENT GRAFTS COMPONENTS FOLLOWED BY A NEED FOR OPEN REPLACEMENT OF THE ASCENDING AORTA AND ARCH DUE TO ANATOMY ASSESSED OUTSIDE IFU. REGARDING THE TYPE IA ENDOLEAK IT HAS BEEN CONFIRMED ON IMAGING REVIEW BASED ON THE ANGIOGRAM. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO ESTABLISH AN EXACT CAUSE, BUT IT IS NOTED THAT THE ANATOMY WAS OUTSIDE IFU.¿ BASED ON THE PROVIDED INFORMATION, THE IMAGING REVIEW AND CLINICAL ASSESSMENT A LIKELY CAUSE FOR THIS EVENT COULD BE RELATED TO THE ANATOMY BEING OUTSIDE IFU AS THE PROXIMAL NECK IS UNSUITABLE FOR ENDOVASCULAR REPAIR. PER THE IFU:¿ THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS OR ULCERS OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: NONANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE THORACIC ANEURYSM OR ULCER WITH A LENGTH OF AT LEAST 20 MM AND WITH A DIAMETER MEASURED OUTER-WALL-TO-OUTER-WALL OF NO GREATER THAN 42 MM.¿ THE PROXIMAL NECK DIAMETER IS 40 MM AT THE LCCA LANDING ZONE AND 44 MM AT THE LSA (15 MM FROM THE LCCA) AND THEREFORE IS UNSUITABLE FOR ENDOVASCULAR REPAIR WITH DIAMETER MEASUREMENTS OUTSIDE THE IFU FOR THIS DEVICE. FURTHERMORE, A ZTA-PT-40-36-217-W1 DEVICE WAS IMPLANTED IN THE PROXIMAL NECK. THE IFU STATES THAT INADEQUATE OVERSIZING (< 10%) OF THE GRAFT DIAMETER MAY RESULT IN ENDOLEAK ETC. IN ADDITION IT IS NOTED IN THE IFU THAT THE SAFETY AND EFFECTIVENESS OF THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT AND ANCILLARY COMPONENTS HAVE NOT BEEN EVALUATED IN PATIENT HAVING DISSECTION, LEAKING, PENDING RUPTURE OR RUPTURED ANEURYSM. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AN 87 YEAR OLD MALE PATIENT UNDERWENT RUPTURE OF DISSECTING ANEURYSM OF THE AORTA REPAIR. ZTA-P-34-161-W1 (LOT:E4042497) WAS PLACED IN THE DESCENDING AORTA AND THEN ZTA-PT-40-36-217-W1 (LOT:E4209804) WAS PLACED FROM ZONE 2. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. THE ASCENDING AORTA WAS ENLARGED AND IT WAS DETERMINED PLACING STENT GRAFT WAS DIFFICULT SINCE PROXIMAL SEALING WOULD NOT BE ACHIEVED, SO THE ASCENDING AORTA REPLACEMENT WAS PERFORMED AND THE ARTIFICIAL VESSEL WAS ANASTOMOSED WITH THE PROXIMAL PART OF THE ZTA-PT-40-36-217-W1 (LOT:E4209804). HOWEVER TYPE III ENDOLEAK FROM PLURAL SUTURE HOLES OF THE TWO ZENITH DEVICES AND TYPE II ENDOLEAK WERE CONFIRMED, SO THE DEVICES WERE EXPLANTED BY OPENING THE CHEST. THEN THE DESCENDING AORTA REPLACEMENT WAS PERFORMED. 1. FIRST, THE LEFT AXILLARY ARTERY AND THE LEFT FEMORAL ARTERY WERE EXPOSED, AND AN 8 MM FUSION GRAFT WAS ANASTOMOSED INTO THE LEFT AXILLARY ARTERY TO FORM A BLOOD SUPPLY CHANNEL. 2. A 8FR SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, A 5FR SHEATH WAS INSERTED FROM THE LEFT FEMORAL ARTERY. RADIFOCUS + PIGTAIL WAS INSERTED FROM THE RIGHT FEMORAL ARTERY 8FR SHEATH AND ADVANCED TO THE ASCENDING AORTA, AND REPLACED WITH A LUNDERQUIST WIRE. IN ADDITION, PIGTAIL CATH WAS INSERTED INTO THE DESCENDING AORTA FROM THE LEFT FEMORAL ARTERY 5FR SHEATH. FIRST, INSERTED THE FIRST STENT (ZTA-P-34-161-WL) SO THAT THE DISTAL 4 CM LANDING ZONE IS ENSURED FROM THE ANEURYSM OF THE DESCENDING THORACIC AORTA. THEN THE SECOND STENT (ZTA-PT-40-36-217-WL) WAS INSERTED FOR THE PROXIMAL SIDE TO BARELY COVER THE LEFT CAROTID ARTERY. AT THIS POINT, ALTHOUGH THERE WAS A TYPE IA ENDOLEAK IN ANGIOGRAPH IMAGE, NO OBVIOUS BLOOD LEAKAGE TO THE OUTSIDE OF THE ANEURYSM WAS OBSERVED. AFTER THIS, A MIDLINE THORACIC INCISION WAS PERFORMED, THE PERICARDIUM WAS INCISED, AND A MODERATE AMOUNT OF SEROUS PERICARDIAL FLUID WAS OBSERVED. AFTER ADMINISTRATION OF HEPARIN 3MG/KG, TRANSAMIN AND STEROID, 24FR, 28R AND DLP CANULA WERE INSERTED INTO SVC AND IVC FROM RA, AND RETROGRADE MYOCARDIAL PROTECTION CANULA WAS INSERTED INTO CS FROM RA TO MAKE CPB ON. AFTER THAT, VENT WAS INSERTED INTO THE LV FROM THE RIGHT UPPER PV AND COOLING WAS STARTED. DURING COOLING, SVC TAPING AND SNARE WAS PERFORMED. FURTHERMORE, INNOMINATE VEIN, INNOMINATE A., IT CAROTID A AND THEIR SURROUNDINGS WERE PEELED OFF. THE ASCENDING AORTA WAS ALSO ANEURYSMAL UP TO 55 MM AND PARTIALLY ADHERED TO THE SURROUNDING AREA. 3. WHEN THE LUMEN WAS SEEN AS A CIRCULATORY ARREST AT A DEEP TEMPERATURE OF 25 ° C, THE AORTA ARCH TO THE ASCENDING AORTA WAS IN THE FORM OF A TRUE ANEURYSM. THE THREE BRANCHES OF THE ARCH WERE ALSO INVOLVED IN THE ANEURYSM, BUT THE ANEURYSM AT THE AREA AROUND THE LEFT CAROTID ARTERY WAS PARTIALLY MILD AS ABOUT 40 MM. THE PLAN WAS TO REPLACE THE ARCH BY SUTURING THIS SITE TOGETHER WITH THE PREVIOUSLY PLACED STENT GRAFT TO FORM A DISTAL STUMP. RETROGRADE AND THEN SELECTIVE ANTEROGRADE MYOCARDIAL PROTECTION WAS INJECTED FOR MYOCARDIAL PROTECTION. 4. THE BRACHIOCEPHALIC TRUNK AND THE LEFT CAROTID ARTERY WERE DISSECTED AND THE PROXIMAL SIDE OF THE LEFT SUBCLAVIAN ARTERY WAS CLOSED WITH HEM-O-LOCK. TWO CANNULAS (15FR, 12FR) FOR ANTEROGRADE CEREBRAL SEPARATION AND BLOOD FEEDING WERE PLACED FOR THE BRACHIOCEPHALIC TRUNK AND THE LEFT COMMON CAROTID ARTERY, AND BLOOD FEEDING WAS STARTED. BLOOD WAS SENT TO THE LEFT AXILLARY ARTERY FROM AN ARTIFICIAL BLOOD VESSEL SET UP IN THE AXILLARY ARTERY. TERUMO¿S TRIPLEX 30 MM VASCULAR GRAFT WAS SELECTED FROM THE DISTAL SIZE, AND THE STENT STRUTS OF THE AORTIC STENT GRAFT NEAR THE DISTAL STUMP WAS REMOVED TO ENABLE ANASTOMOSIS. 5. STENT WAS TRIMMED TO FIT THE DISTAL ANASTOMOTIC SITE, AND THEN FIXED AT 4 POINTS WITH THE AORTIC WALL USING 4-0 PROLENE, AND THEN WRAPPED WITH 1.5 CM WIDE FELT WITH DARNING THREAD, AND SAWED IT TO THE 30 MM TRIPLEX USING 3-0 PROLENE SH USING OVER AND OVER TECHNIQUE. AFTER ANASTOMOSIS, THE ARTIFICIAL BLOOD VESSEL WAS BLOCKED AND BLOOD WAS SENT FROM THE DISTAL. MATTRESS SUTURE WITH 3-0 ETHIBOND PLEDGET WAS PERFORMED FOR THE BLEEDING LOCATION TO STOP BLEEDING. 6. A 7MM TEFLON FELT WAS WRAPPED AROUND THE ARCH BRANCHES AND ANASTOMOSED THE LEFT COMMON CAROTID ARTERY AND THE BRACHIOCEPHALIC TRUNK USING 5-0 RB-1. AFTER THAT, THE 5/16-3/8 CONNECTOR WAS CONNECTED TO THE BRANCHES OF THE VASCULAR GRAFT. THEN AFTER CONNECTED TO THE BLOOD FEEDING TUBE AND REMOVING THE AIR, SYSTEMIC PERFUSION WAS RESUMED. 7. THE BASE OF THE AORTA WAS CUT SLIGHTLY PROXIMAL TO THE STJ, AND A TACHOSIL AND FELT WITH DARNING THREAD WERE WRAPPED AROUND IT, AND IT WAS STITCHED BY CONTINUOUS STITCHING TO THE PROXIMAL OF THE TRIPLEX 30 MM VASCULAR GRAFT USING 4-0 PROLENE. 8. AFTER FINAL RETRO CP INJECTION AND AIR REMOVAL, THE AORTIC BLOCKAGE WAS RELEASED. 9. AFTER DECLAMP, THE HEARTBEAT RESUMED. DURING THE REWARMING, AN 8MM FUSION GRAFT CONNECTED TO THE LEFT AXILLARY ARTERY WAS GUIDED TO THE ANTERIOR MEDIAL SEGMENT, AND IT WAS ANASTOMOSED TO THE REMAINING ONE BRANCH OF THE TRIPLEX USING 3-0 ETHIBOND. AFTER THE REWARMING WAS COMPLETED, THE AIR WAS REMOVED, THEN THE LV VENT OFF WAS REMOVED, AND THEN CPB WEANING OFF WAS PERFORMED. 10. HOWEVER, AFTER THAT, A DECREASE IN BLOOD PRESSURE AND BLEEDING INTO THE LEFT THORACIC CAVITY OCCURRED, AND A SEARCH REVEALED THAT THE BLEEDING FROM THE RUPTURED HOLE OF THE ANEURYSM RECURRED. AN ATTEMPT WAS MADE TO CLOSE THE RUPTURE HOLE, BUT THE TISSUE WAS EXTREMELY FRAGILE AND DIFFICULT TO ANASTOMOSE. 11. PERFORMED THE LEFT 4TH INTERCOSTAL CHEST OPENING, ADDED THE BLOOD TRANSMISSION TUBE FROM THE RIGHT FEMORAL ARTERY, STARTED THE ARTIFICIAL CARDIOPULMONARY REPLENISHMENT AGAIN. THE DISTAL DESCENDING AORTA OF THE STENT PART WAS PEELED AND BLOCKED WITH ARTIFICIAL BLOOD VESSEL AND RIGHT FEMORAL ARTERY BLOOD SUPPLY. THE PROXIMAL WAS BLOCKED AT THE PART OF THE DISTAL SIDE OF THE ARTIFICIAL BLOOD VESSEL WHERE A SEWING MARGIN COULD BE MADE. 12. WHEN THE AORTA WAS INCISED, THERE WAS THE ENDOLEAK FROM THE INTERCOSTAL ARTERY AND TYPE III ENDOLEAK AS A LOT OF BLEEDING FROM THE SUTURE HOLES OF THE STENT GRAFTS. FOR THE INTERCOSTAL ARTERY, STITCH WITH 3-0 ETHIBOND TO STOP BLEEDING WAS PERFORMED. THEN REMOVED THE DISTAL OF THE STENT FIRST, AND SELECTED TRIPLEX 1-BRANCHED ACCORDING TO THE DIAMETER OF THE DISTAL AORTA. WRAPPED AROUND THE AORTA WITH FELT WITH A THREAD AND DISTAL CONTINUOUS ANASTOMOSIS WAS PERFORMED USING 4-0 PROLENE SH-1. 13. IN ADDITION, ABOUT THE PROXIMAL SIDE, THE DISTAL END OF THE TRIPLEX WAS PEELED OFF AND EXPOSED, ALL THE STENTS WERE CUT. THE DISTAL OF ANOTHER TRIPLEX WITH 4 BRANCHES WAS CONTINUOUSLY SUTURED USING 3-0 ETHIBOND TO THE TRIPLEX SUTURED TO THE DESCENDING AORTA. 14. AT THIS TIME, AFTER WEANING THE ARTIFICIAL CARDIOPULMONARY SYSTEM AND ADMINISTERING PROTAMIN, IT WAS CONFIRMED THAT THE BLEEDING WAS STOPPED, AND ADDITIONAL ARREST OF BLEEDING FOR THE INTERCOSTAL ARTERY WAS PERFORMED. 15. THEN, THE PATIENT WAS WITHDRAWN FROM THE ARTIFICIAL CARDIOPULMONARY SYSTEM AND CPB WAS TURNED OFF. 16. WE MANAGED TO CONTROL BLEEDING FROM BLOOD VESSELS SUCH AS THE ANASTOMOSIS SITE OF LARGE VESSEL AND THE INTERCOSTAL ARTERY, BUT IT WAS DIFFICULT TO CONTROL OOZING FROM THE INCISION SITE, CHEST WALL, ETC., AND BECAME HYPOTENSION GRADUALLY DUE TO ANASARCA DUE TO LONG-TERM EXTRACORPOREAL CIRCULATION AND CARDIAC ARREST. HYPOTENSION PROLONGED, SO V-A ECMO WAS ATTACHED. 17. ALSO, THE ABDOMEN WAS SIGNIFICANTLY DISTENDED, AND A EXPLORATORY LAPAROTOMY WAS PERFORMED AS A GASTROENTEROLOGICAL CONSULTANT. ALTHOUGH THERE WAS SEVERE EDEMA IN THE INTESTINAL TRACT, NO ISCHEMIA WAS OBSERVED, AND THE OPERATION WAS ENDED WITH THE ABDOMEN AND CHEST OPEN. ( B)(6) 2022: AT 13:00, HE ENTERED THE ICU AS INTUBATED AND ATTACHED TO V-A ECMO. AFTER THE OPERATION, THE BLOOD PRESSURE WAS MAINTAINED AT AROUND 100/70 MMHG WHILE ADMINISTERING BLOOD TRANSFUSION. THE ADMINISTRATION OF POSTOPERATIVE PLATELETS SEEMED TO REDUCE THE BLEEDING FROM THE DRAIN, BUT THE BLEEDING AROUND THE GRAFT WAS 300 ML/H AND THE BLEEDING IN THE LEFT THORACIC CAVITY WAS 370 ML/H 1 HOUR AFTER ENTERING THE ICU. AFTER THAT, WHILE CONTINUOUSLY INFUSING BLOOD, VA-ECMO WAS GIVEN AT 3L/MIN, AND THE BLOOD PRESSURE REMAINED IN THE 80/50MMHG RANGE AND HB9G/DL RANGE, BUT ADVANCED ACIDEMIA PROGRESSED AND BLEEDING DID NOT STOP. THE BLOOD COAGULATION ABILITY WAS EXTENDED TO THE POINT WHERE APTT COULD NOT BE MEASURED, AND THE FIB QUANTIFICATION WAS WELL BELOW THE LOWER LIMIT, RESULTING IN A REMARKABLE DIC STATE. BEFORE 18:00, THE AMOUNT OF BLEEDING AROUND THE GRAFT AFTER RETURNING TO THE ROOM WAS 695ML, AND THE AMOUNT OF BLEEDING IN THE LEFT THORACIC CAVITY WAS 4900ML. IN TOTAL, 24 UNITS OF RBC, 24 UNITS OF FFP, AND 20 UNITS OF PC WERE ADMINISTERED, BUT HB TENDED TO DECREASE, THE STATUS OF DIC AND ACIDEMIA DID NOT CHANGE, AND BLEEDING WAS UNCONTROLLABLE. IT WAS CONSIDERED DIFFICULT TO STOP BLEEDING AND SAVE LIFE BY FURTHER TRANSFUSION. ALTHOUGH WE CONSIDERED STOPPING BLEEDING BY RE-OPERATION, IT IS DIFFICULT TO STOP BLEEDING BY SURGERY BECAUSE OF THE DIC STATE, AND IT IS CONSIDERED THAT THERE IS A HIGH RISK OF INTRAOPERATIVE DEATH. IT WAS JUDGED PERFORMING RE-OPERATION WAS MORE DANGEROUS THAN CURRENT SITUATION. AS A RESULT OF EXPLAINING THESE SITUATIONS TO THE FAMILY, IT IS DIFFICULT TO SAVE LIFE BY RE-OPERATION AND FURTHER BLOOD TRANSFUSION, SO NO MORE BLOOD TO TRANSFUSION WAS ORDERED. AFTER THAT, ADMINISTERING THE REMAINING 12 UNITS OF FFP AND 10 UNITS OF PC WAS FINISHED, BUT THE BLEEDING DID NOT SUBSIDE AND THE BLOOD PRESSURE GRADUALLY DECREASED. AFTER 22:00, THE PUMP FLOW RATE OF ECMO DECREASED TO L.7L/MIN AND THE BLOOD PRESSURE BECAME CONSTANT AT AROUND 30/20MMHG, AND THE BLOOD PRESSURE BY THE HEART ITSELF ALMOST DISAPPEARED AND BECAME COMPLETELY DEPENDENT ON THE PUMP FLOW RATE. THE HEART RATE DECREASED WITH THE BLOOD PRESSURE, AND AROUND 3:00, IT BECAME AROUND HR40 AND SP02 BECAME UNDETECTABLE. AT 3:45 HE SUDDENLY BECAME ASYSTOLE FROM HR40. AFTER THAT, NO RESUSCITATION ATTEMPT WAS PERFORMED, AND THE DEATH WAS CONFIRMED BY THE PHYSICIAN AT AM4: 00 ON (B)(6) 2022. PATIENT OUTCOME: THE PATIENT DECEASED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951646 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E4209804 | 10827002448695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Male | Death |