ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS
Report
- Report Number
- 3002808486-2018-01005
- Event Type
- Death
- Date Received
- September 4, 2018
- Date of Event
- August 13, 2018
- Report Date
- January 31, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002448848
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. INVESTIGATION IS STILL IN PROGRESS
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT FOCUSES ON DEPLOYMENT DIFFICULTY FACED BY THE CUSTOMER IN RELEASING THE BARE STENT OF THE ZTA-D-36-142-W1. THE IMPLANT DATE WAS PLACED ON (B)(6) 2018. THE FOLLOWING WAS REPORTED IN THE COMPLAINT FILE: IT WAS REPORTED THAT THE CUSTOMER FOLLOWED THE STEPS ADDRESSED IN THE IFU INCLUDING TROUBLESHOOTING WITHOUT BEING ABLE TO RELEASE THE BARE STENT. FOR THIS REASON, IN ORDER TO RELEASE THE STENT GRAFT, THE CUSTOMER DEPLOYED THE PROXIMAL END OF THE GRAFT FIRST, THEN PULLED THE INTRODUCTION SYSTEM TO UNCOVER THE BARE STENT FROM THE BOTTOM CAP, HOWEVER; THE OUTCOME OF THIS STEP RESULTED IN COVERING THE ORIGIN OF THE SMA. IN ADDITION, THE VESSEL RUPTURED, NEAR THE RENAL ARTERIES DURING THE PROCESS OF PULLING BACK THE INTRODUCTION SYSTEM. OPEN REPAIR TO TREAT THE RUPTURED VESSEL AND COVERAGE OF SMA WAS PERFORMED. PATIENT DECEASED ONE DAY POST PROCEDURE. FURTHERMORE, SEVERE TORTUOSITY IN THE PATIENT¿S ANATOMY WAS NOTED AND ADVANCEMENT DIFFICULTY WAS REPORTED IN THE PRIOR STEPS OF THE PROCEDURE. AS A CONSEQUENCE, THE PHYSICIAN SWITCHED FROM ZTA-30-155-W1 TO THE ZTA-DE-38-91-W1. THIS EVENT IS ADDRESSED IN A SEPARATE COMPLAINT ((B)(4)). FOR THE INVESTIGATION, IMAGING AND PRODUCT WERE BOTH PROVIDED. THE FINDINGS ARE AS FOLLOWS: IMAGES WERE PROVIDED FOR INVESTIGATION WHICH INCLUDED IMPLANTATION ANGIOGRAPHY, TWO IMAGES DUPLICATED FROM THE ANGIOGRAPHY, AND PREIMPLANTATION CTA. AS PER IMAGING REVIEW, THE PREIMPLANTATION CTA DEMONSTRATED A LARGE DISTAL THORACIC AORTIC ANEURYSM IN BETWEEN A REMOTELY IMPLANTED DESCENDING THORACIC GRAFT AND SEVERELY IRREGULAR AND TORTUOUS AORTA. THE ANEURYSM WAS SO SEVERELY ANGULATED THAT IT WAS FOLDED INTO A Z-SHAPED CONFIGURATION AS IT TRAVELED ALONG THE DIAPHRAGM AND THEN TURNED TO ENTER THE ABDOMEN. THE FIRST IMAGE WAS A FLUOROSCOPIC IMAGE THAT MOST LIKELY REPRESENTS WHEN THE DISTAL STENT RELEASE DIFFICULTY WAS ENCOUNTERED. THE GRAFT WAS STILL LOCATED ABOVE THE CELIAC ARTERY WHEN COMPARING ITS LOCATION RELATIVE TO THE SPINE. THE TRIGGER WIRE WAS ABSENT. THE DISTAL STENT WAS MILDLY FUNNELED BUT STILL CONSTRAINED BY THE BARE STENT CAP. ONE OF THE RIGHT STENT APICES WAS LOWER THAN THE OTHERS. THE APEX´S DISTANCE FROM THE BASE OF THE CAP TO THE STENT MATCHED THE DISTANCE FOR A BARB ENGAGED IN THE CAP. THIS SUGGEST THAT THE BARB OF THIS STENT MAY HAVE BEEN CAUGHT IN THE CAP. THE INTRODUCER SHEATH WAS BELOW THE CAP. THE SECOND IMAGE WAS FROM AN ANGIOGRAM PERFORMED AFTER THE ENDOGRAFT HAD BEEN PULLED DOWN. THE DISTAL STENT WAS STILL CONSTRAINED IN THE CAP. BECAUSE IT WAS THE SAME DISTANCE FROM THE CAP THAT IT HAD BEEN IN THE PREVIOUS IMAGE, A BARB WAS LIKELY STILL ENGAGED IN THE CAP. THE DISTAL STENT WAS JUST INFERIOR TO THE LEFT RENAL ARTERY. THE ENDOGRAFT WAS TWO VERTEBRAL BODIES LOWER THAN ON THE PREVIOUS IMAGE. SMA AND CELIAC ARTERY ORIGINS WERE NOW COVERED BY THE GRAFT. THE INTRODUCER SHEATH WAS STILL BELOW THE CAP. PER THE IMAGING, COVERAGE OF THE SMA AND CELIAC ARTERY ORIGINS FROM PULLING THE GRAFT DOWN TO RELEASE THE DISTAL STENT IS CONFIRMED. THE PROVIDED IMAGING DOES NOT REFLECT THE USE OF TROUBLESHOOTING PROCEDURE, AS FORWARD ADVANCEMENT OF THE INTRODUCTION SHEATH INDICATING IT HAD BEEN TRIED, WAS NOT OBSERVED. ACCORDING TO THE RECEIVED INFORMATION IN THE DESCRIPTION OF EVENT, TROUBLESHOOTING WAS PERFORMED BUT FAILED TO RELEASE THE BARE STENT. IN ADDITION TO THE IMAGING, DISASSEMBLED INTRODUCTION SYSTEM WAS RETURNED FOR EVALUATION. PER THE PRODUCT ANALYSIS, IT WAS NOTED THAT THE BLUE ROTATION HANDLE HAD BEEN REMOVED ALONG WITH THE RELEASING WIRES AND SHEATH WAS NOT RETURNED. EXAMINATION OF THE BOTTOM CAP WAS PERFORMED USING LIGHT MICROSCOPY. THE BOTTOM CAP WAS NOTED TO BE DAMAGED. AFTER REMOVING BLOOD MATTER FROM THE COMPONENT, THE DAMAGE SUGGESTS THAT ONE OF THE BARBS HAD LIKELY PENETRATED THROUGH THE WALL OF THE BOTTOM CAP. BARB PENETRATION THROUGH THE BOTTOM CAP HAS LIKELY PREVENTED THE DISTAL END OF THE STENT GRAFT FROM RELEASING. THIS EXPLAINS THE FINDINGS IN THE IMAGING REVIEW WHERE IT IS STATED THAT THE DISTAL END OF THE STENT WAS STILL CONSTRAINED IN THE CAP AND A BARB WAS LIKELY STILL ENGAGED IN THE CAP. THE CAUSE FOR BARB PENETRATION COULD NOT BE DETERMINED AND THAT IS WHY INTERNAL ACTION HAS BEEN INITIATED TO INVESTIGATE THE ROOT CAUSE. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO THE SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT FOCUSES ON DEPLOYMENT DIFFICULTY FACED BY THE PHYSICIAN IN RELEASING THE BARE STENT OF THE ZTA-D-36-142-W1. IT WAS REPORTED THAT THE PHYSICIAN FOLLOWED THE STEPS ADDRESSED IN THE IFU INCLUDING TROUBLESHOOTING WITHOUT BEING ABLE TO RELEASE THE BARE STENT. TO RELEASE THE STENT GRAFT, THE PHYSICIAN DEPLOYED THE PROXIMAL END OF THE GRAFT FIRST, THEN PULLED THE INTRODUCTION SYSTEM TO UNCOVER THE BARE STENT FROM THE BOTTOM CAP, HOWEVER; THE OUTCOME OF THIS STEP RESULTED IN COVERING THE ORIGIN OF THE SMA. ALSO, THE VESSEL RUPTURED, NEAR THE RENAL ARTERIES, WHEN THE INTRODUCTION SYSTEM WAS PULLED. OPEN REPAIR TO TREAT THE RUPTURED VESSEL AND COVERAGE OF SMA WAS PERFORMED. PATIENT DECEASED ONE DAY POST PROCEDURE. FURTHERMORE, ADVANCEMENT DIFFICULTY WAS ALSO REPORTED FROM THE SAME PROCEDURE. THIS EVENT IS ADDRESSED IN A SEPARATE COMPLAINT ((B)(4)). IMAGES WERE PROVIDED FOR INVESTIGATION WHICH INCLUDED IMPLANTATION ANGIOGRAPHY, TWO IMAGES DUPLICATED FROM THE ANGIOGRAPHY, AND PREIMPLANTATION CTA. AS PER IMAGING REVIEW, THE PREIMPLANTATION CTA DEMONSTRATED A LARGE DISTAL THORACIC AORTIC ANEURYSM IN BETWEEN A REMOTELY IMPLANTED DESCENDING THORACIC GRAFT AND SEVERELY IRREGULAR AND TORTUOUS AORTA. THE ANEURYSM WAS SO SEVERELY ANGULATED THAT IT WAS FOLDED INTO A Z-SHAPED CONFIGURATION AS IT TRAVELED ALONG THE DIAPHRAGM AND THEN TURNED TO ENTER THE ABDOMEN. THE FIRST IMAGE WAS A FLUOROSCOPIC IMAGE THAT WAS MOST LIKELY TAKEN WHEN DISTAL STENT RELEASE DIFFICULTY WAS ENCOUNTERED. THE GRAFT WAS STILL LOCATED ABOVE THE CELIAC ARTERY WHEN COMPARING ITS LOCATION RELATIVE TO THE SPINE. THE TRIGGER WIRE WAS ABSENT. THE DISTAL STENT WAS MILDLY FUNNELED BUT STILL CONSTRAINED BY THE BARE STENT CAP. ONE OF THE RIGHT STENT APICES WAS LOWER THAN THE OTHERS. BECAUSE ITS DISTANCE FROM THE BASE OF THE CAP TO THE STENT MATCHED THE DISTANCE FOR A BARB ENGAGED IN THE CAP WIRE HOLE, THIS LOWER POSITION INDICATES THAT ITS BARB WAS CAUGHT IN THE CAP WIRE HOLE. THE INTRODUCER SHEATH WAS BELOW THE CAP. THE SECOND IMAGE WAS FROM AN ANGIOGRAM PERFORMED AFTER THE ENDOGRAFT HAD BEEN PULLED DOWN. THE DISTAL STENT WAS STILL CONSTRAINED IN THE CAP. BECAUSE IT WAS THE SAME DISTANCE FROM THE CAP THAT IT HAD BEEN IN THE PREVIOUS IMAGE, A BARB WAS LIKELY STILL ENGAGED IN THE CAP HOLE. THE DISTAL STENT WAS JUST INFERIOR TO THE LEFT RENAL ARTERY. THE ENDOGRAFT WAS TWO VERTEBRAL BODIES LOWER THAN ON THE PREVIOUS IMAGE. SMA AND CELIAC ARTERY ORIGINS WERE NOW COVERED BY THE GRAFT. THE INTRODUCER SHEATH WAS STILL BELOW THE CAP. PER THE IMAGING, COVERAGE OF THE SMA AND CELIAC ARTERY ORIGINS FROM PULLING THE GRAFT DOWN TO RELEASE THE DISTAL STENT IS CONFIRMED. THE PROVIDED IMAGING DOES NOT REFLECT THE USE OF TROUBLESHOOTING PROCEDURE, AS FORWARD ADVANCEMENT OF THE INTRODUCTION SHEATH INDICATING IT HAD BEEN TRIED, WAS NOT OBSERVED. ACCORDING TO THE RECEIVED INFORMATION IN THE DESCRIPTION OF EVENT, TROUBLESHOOTING WAS PERFORMED BUT FAILED TO RELEASE THE BARE STENT. LASTLY, AORTIC RUPTURE AWAY FROM THE ENDOGRAFT ALONG THE LEFT INFRA-RENAL AORTA IS CONFIRMED. THE LOCATION IS CONSISTENT WITH THE CLINICAL IMPRESSION THAT THE ENDOGRAFT DID NOT RUPTURE THE AORTA. IN ADDITION TO THE IMAGING, DISASSEMBLED INTRODUCTION SYSTEM WAS RETURNED FOR EVALUATION. PER THE ANALYSIS, IT WAS NOTED THAT THE BLUE ROTATION HANDLE HAD BEEN REMOVED ALONG WITH THE RELEASING WIRES. EXAMINATION OF THE BOTTOM CAP WAS PERFORMED USING LIGHT MICROSCOPY. THE BOTTOM CAP WIRE HOLE WAS NOTED TO BE DAMAGED. AFTER REMOVING BLOOD MATTER FROM THE COMPONENT, IT WAS EVIDENT THAT THE BARB HAD PENETRATED THROUGH THE WALL OF THE BOTTOM CAP AT THE AREA WHERE THE WIRE HOLE IS LOCATED. BY USING A ZTA-D STENT GRAFT IT WAS POSSIBLE TO PASS A BARB THROUGH THE HOLE FOUND ON THE RETURNED BOTTOM CAP AT THE AREA WHERE THE WIRE HOLE IS LOCATED. BARB PENETRATION THROUGH THE BOTTOM CAP HAS PREVENTED THE DISTAL END OF THE STENT GRAFT FROM RELEASING. THIS EXPLAINS THE FINDINGS IN THE IMAGING REVIEW WHERE IT IS STATED THAT THE DISTAL END OF THE STENT WAS STILL CONSTRAINED IN THE CAP DUE TO A BARB WAS LIKELY STILL ENGAGED IN THE CAP HOLE. THE CAUSE FOR BARB PENETRATION COULD NOT BE DETERMINED. INTERNAL ACTIONS HAVE BEEN TAKEN. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. CORRECTED DATA: GENDER: FEMALE. DESCRIPTION OF THE PROBLEM: RPN IN DESCRIPTION OF EVENT, RELATING TO (B)(4).
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4).G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A MALE PATIENT UNDERWENT TEVAR FOR TAA. THE USER ADVANCED A DELIVERY SYSTEM OF ZTA-DE-38-91-W1, BUT IT WOULD NOT ADVANCE. THEREFORE, ANOTHER DEVICE WAS USED INSTEAD. ((B)(4)). THE USER ATTEMPTED TO PLACE ZTA-D-36-142-W1. THOUGH HE MANIPULATED THE DEVICE WITH FOLLOWING THE NORMAL PROCEDURE, THE BARE STENT WOULD NOT BE DEPLOYED. PERSPECTIVE IMAGES COULD NOT CONFIRM THE STATE, BUT THE STENT MIGHT HAVE BEEN STILL INSIDE THE BOTTOM CAP. THEREFORE, HE DEPLOYED THE PROXIMAL END OF THE GRAFT FIRST, THEN PULLED THE WHOLE DELIVERY SYSTEM IN ORDER TO UNCOVER THE BARE STENT FROM THE BOTTOM CAP TO DEPLOY. THE BARE STENT COULD BE DEPLOYED EVENTUALLY, BUT THE DISTAL COMPONENT WAS ALSO PULLED DISTALLY WHEN THE WHOLE DELIVERY SYSTEM WAS PULLED RESULTING IN COVERING THE ORIGIN OF THE SMA. ALSO, THE VESSEL RUPTURED FROM NEAR THE RENAL ARTERIES WHEN THE DELIVERY SYSTEM WAS PULLED. SMA BYPASS AND OPEN CONVERSION TO TREAT THE RUPTURED VESSEL WAS PERFORMED. ((B)(4)). AS OF (B)(6) 2018, THE PATIENT OUTCOME IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED 16AUG2018: THE PATIENT EXPIRED. ADDITIONAL INFORMATION RECEIVED 21AUG2018: THE PATIENT WAS NOT SUITABLE FOR THE PROCEDURE BECAUSE THE HEMATOMA DUE TO CONTAINED RUPTURE ENLARGED RAPIDLY, THE PATIENT HAD HISTORY OF REPLACEMENT OF THE DESCENDING AORTA, AND BECAUSE ADHESION WAS OBSERVED. SINCE IT WOULD HAVE BEEN DIFFICULT TO PERFORM OPEN CHEST SURGERY WITH THESE PATIENT CONDITIONS, TEVAR WAS SELECTED. THERE WAS SEVERE TORTUOSITY IN THE PATIENT¿S ANATOMY. THE PHYSICIAN THINKS THAT THE CAUSE OF DEATH WAS SHOWER EMBOLISM BECAUSE THE PULSE COULD BE FELT AFTER BYPASS PERFORMED IMMEDIATELY AFTER CLOSING THE ORIGIN OF THE SMA WITH THE STENT GRAFT, AND ALSO BECAUSE BLEEDING DUE TO VESSEL RUPTURE COULD BE SMOOTHLY ARRESTED. THE PATIENT EXPIRED AT 16:29 ON THE (B)(6) 2018. AUTOPSY WILL NOT BE PERFORMED. ADDITIONAL INFORMATION RECEIVED 24AUG2018: ¿THE RUPTURED POINT WAS AT BELOW THE LEFT RENAL ARTERY. THE PHYSICIAN THINKS THAT THE CAUSE OF RUPTURE WAS NOT THE BARE STENT OF ZENITH BUT A WIRE GUIDE OR CATHETER.¿ DETAILS ARE PROVIDED AS BELOW. ANGIOGRAPHY WAS ATTEMPTED WITH USING ANOTHER MANUFACTURERS PIGTAIL ANGIOGRAPHIC CATHETER AND ANOTHER MANUFACTURERS RADIFOCUS IN ORDER TO CHECK THE POSITION BEFORE PULLING THE DELIVERY SYSTEM DISTALLY TO DEPLOY THE BARE STENT. HOWEVER, THE PIGTAIL CATHETER WAS CAUGHT ON SOMETHING NEAR THE BARE STENT DURING ADVANCEMENT, WHICH MADE IT IMPOSSIBLE TO PERFORM ANGIOGRAPHY WITH THE PIGTAIL CATHETER. THEREFORE, RADIFOCUS WAS REPLACED WITH COOK¿S WIRE GUIDE (TSCMG-35-300-LESDC) AND REMOVAL OF THE PIGTAIL CATHETER WAS ATTEMPTED. HOWEVER, BECAUSE THE PIGTAIL BROKE DURING REMOVAL, THE WIRE GUIDE AND CATHETER WERE REPLACED WITH PREVIOUSLY USED RADIFOCUS AND ANOTHER MANUFACTURERS MULTIPURPOSE ANGIO CATHETER TO PERFORM ANGIOGRAPHY. THE PHYSICIAN THINKS THAT THE RUPTURE WAS CREATED DURING THIS TIME (BETWEEN THE ATTEMPT AND PERFORMANCE OF ANGIOGRAPHY.)
ADDITIONAL INFORMATION RECEIVED ON 20SEP2018: THE PHYSICIAN USED THE DEVICE WITH FOLLOWING THE NORMAL PROCEDURE, WHICH I BELIEVE THAT HE ADVANCED THE DELIVERY SYSTEM THROUGH THE PATIENT ANATOMY AS NORMAL. DETAILED INFORMATION ABOUT WHAT THE PHYSICIAN DID FROM WHEN HE ATTEMPTED TO DEPLOY THE STENT GRAFT TO WHEN HE FINISHED USING THE DEVICE: 1. THE PHYSICIAN PULLED BACK THE FLEXOR SHEATH TO EXPAND THE STENT GRAFT. 2. SUBSEQUENTLY, HE PERFORMED EACH STEP WITH FOLLOWING THE NORMAL PROCEDURE UNTIL HE CONFIRMED THAT THE RELEASE WINDOW TURNED GREEN. 3. HE NOTICED THAT THE BARE STENT WAS NOT DEPLOYED ALTHOUGH HE FINISHED EVERY STEP TO DEPLOY THE STENT GRAFT FULLY. THEREFORE, HE APPLIED THE TROUBLESHOOTING PROCEDURE SHOWN ON THE PACKAGE INSERT; HE ADVANCED THE FLEXOR SHEATH TO THE DISTAL EDGE OF THE STENT GRAFT. 4. SINCE HE DID NOT FEEL ANY RESISTANCE WHEN ADVANCING THE FLEXOR SHEATH PAST THE NON-DEPLOYED BARE STENT, HE THOUGHT THAT THE EVENT (= BARE STENT WOULD NOT DEPLOY) WAS CAUSED NOT BECAUSE THE BARE STENT WAS CAUGHT ON A HOLE BUT BECAUSE BARE STENT WAS STILL INSIDE THE BOTTOM CAP. 5. SINCE THE STENT GRAFT STARTED TO MIGRATE DISTALLY, HE TURNED THE BLUE ROTATION HANDLE TO OPEN THE PROXIMAL END OF THE GRAFT IN ORDER TO FIX THE PROXIMAL SIDE OF THE STENT GRAFT TO THE VESSEL. 6. HE JUDGED THAT THE BOTTOM CAP WAS NOT COMPLETELY PULLED DOWN, SO HE THOUGHT HE HAD NO CHOICE BUT TO PULL THE BLUE ROTATION HANDLE OR THE WHOLE DELIVERY SYSTEM IN ORDER TO UNCOVER THE BARE STENT FROM THE BOTTOM CAP. 7. HE REMOVED THE BACK-END CAP, THEN PULLED THE RELEASE WIRES BEFORE PERFORMING #6 ABOVE TO AVOID NUISANCE THAT WOULD HAVE OCCURRED IF THE RELEASE WIRES HAD REMAINED OR BEEN CAUGHT ON SOMETHING. 8. HE CHECKED THE LENGTH AND NUMBER OF THE RELEASE WIRES. AFTER CONFIRMING THAT THE WIRES HAD NO PROBLEM, HE PULLED THE WHOLE DELIVERY SYSTEM, THEN THE BARE STENT COULD BE FULLY DEPLOYED. THE REMOVED HANDLE AND WIRES WERE DISCARDED INTO A WASTE BOX WHICH CONTAINED NEEDLES, SO THE REP DID NOT RETRIEVE THEM BY CONSIDERING DANGER OF PUTTING HIS HAND INTO THE BOX.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
CORRECTION RECEIVED 16-NOV-2018: "THE USER ADVANCED A DELIVERY SYSTEM OF ZTA-P-30-155-W1, BUT IT WOULD NOT ADVANCE. THEREFORE, ANOTHER DEVICE WAS USED INSTEAD. ((B)(4))".
ADDITIONAL INFORMATION PROVIDED ON 10DEC2018: ((B)(4)): THE USER ADVANCED A DELIVERY SYSTEM OF ZTA-P-30-155-W1, BUT IT WOULD NOT ADVANCE. THEREFORE, ANOTHER DEVICE (ZTA-DE-30-108-W1/ (B)(4)) WAS USED INSTEAD. UPDATE ON 11DEC2018 ((B)(4)): THE USER ATTEMPTED TO PLACE ZTA-D-36-142-W1. THOUGH HE MANIPULATED THE DEVICE WITH FOLLOWING THE NORMAL PROCEDURE, THE BARE STENT WOULD NOT BE DEPLOYED. PERSPECTIVE IMAGES COULD NOT CONFIRM THE STATE, BUT THE STENT MIGHT HAVE BEEN STILL INSIDE THE BOTTOM CAP. THEREFORE, HE DEPLOYED THE PROXIMAL END OF THE GRAFT FIRST, THEN PULLED THE WHOLE DELIVERY SYSTEM IN ORDER TO UNCOVER THE BARE STENT FROM THE BOTTOM CAP TO DEPLOY. THE BARE STENT COULD BE DEPLOYED EVENTUALLY, BUT THE DISTAL COMPONENT WAS ALSO PULLED DISTALLY WHEN THE WHOLE DELIVERY SYSTEM WAS PULLED RESULTING IN COVERING THE ORIGIN OF THE SMA. ALSO, THE VESSEL RUPTURED FROM NEAR THE RENAL ARTERIES DURING THE PROCESS RELATED TO PULLING DOWN THE DELIVERY SYSTEM. SMA BYPASS AND OPEN CONVERSION TO TREAT THE RUPTURED VESSEL WAS PERFORMED. THE PATIENT STATE BECAME STABLE AFTER THE SMA BYPASS AND OPEN CONVERSION, SO ZTA-DE-38-91-W1/ (B)(4) WAS ADDITIONALLY PLACED TO BRIDGE ZTA-DE-30-108-W1 AND ZTA-D-36-142-W1 (COMPLAINT DEVICE) TO SEAL THE GAP BETWEEN THESE TWO STENT GRAFTS CAUSED BY PULLING THE DELIVERY SYSTEM OF THE COMPLAINT DEVICE. THEN, THE PROCEDURE WAS COMPLETED. HOWEVER, THE PATIENT EXPIRED ON THE NEXT DAY. *THERE IS NO CHANGE IN INFORMATION ABOUT PATIENT DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682361 | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3680687 | 10827002448848 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |