ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Report
- Report Number
- 3002808486-2018-01004
- Event Type
- Death
- Date Received
- September 4, 2018
- Date of Event
- August 13, 2018
- Report Date
- January 4, 2019
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002449227
- Adverse Event
- Yes
- Product Problem
- 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.
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 A MALE PATIENT UNDERWENT TEVAR FOR TAA. THE USER ADVANCED ALPHA, BUT IT WOULD NOT ADVANCE, AND ANOTHER DEVICE WAS USED INSTEAD WITHOUT REPORTING HARM IN RELATION TO THIS EVENT. AT FIRST THE COMPLAINT WAS CREATED ON THE RPN ZTA-DE-38-91-W1 AND WAS CHANGED TO ZTA-P-30-155-W1 BASED ON THE IMAGING REVIEW AND VERIFICATION FROM THE SALES REPRESENTATIVE. AS STATED, THE ANGIOGRAPHY DEMONSTRATED THAT IT WAS THE ZTA-P-30-155-W1 THAT WOULD NOT ADVANCE AND THE ZTA-DE-30-108-W1 WAS SUCCESSFULLY ADVANCED. BECAUSE ZTA-D-36-142-W1 WAS DEPLOYED MORE INFERIOR THAN INTENDED, ITS OVERLAP WITH THE ZTA-DE-30-108-W1 WAS REDUCED TO ONE STENT BODY LENGTH. ZTA-DE-38-91-W1 WAS REQUIRED TO SEAL A TYPE ILL COMPONENT/COMPONENT ENDOLEAK THAT OCCURRED THROUGH THE INADEQUATE OVERLAP ON COMPLETION ANGIOGRAPHY. IMAGING OF THE ZTA-DE-38-91-W1 WAS NOT PROVIDED. BASED ON THE PROVIDED INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE. THE PACKAGE INSERT OF THE DEVICE ADDRESSES THE FOLLOWING WHEN RESISTANCE IS FELT: "STOP AND DO NOT CONTINUE ADVANCING THE WIRE GUIDE OR ANY PORTION OF THE INTRODUCTION SYSTEM PRIOR TO REMOVING CAUSES OF RESISTANCE IF RESISTANCE IS FELT DURING ADVANCING THE WIRE GUIDE OR ANY PORTION OF THE INTRODUCTION SYSTEM. EXERCISE PARTICULAR CARE IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS, OR CALCIFIED OR TORTUOUS VESSELS.; VESSEL, CATHETER, OR GRAFT DAMAGE MAY OCCUR". COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
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 (B)(6) 2018: THE PATIENT EXPIRED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018: 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 (B)(6) 2018: ¿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.) PATIENT OUTCOME: AS OF (B)(6) 2018, THE PATIENT OUTCOME IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018: THE PATIENT EXPIRED.
ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018: THE USER ADVANCED A DELIVERY SYSTEM OF ZTA-P-30-155-W1, BUT IT WOULD NOT ADVANCE. THEREFORE, ANOTHER DEVICE WAS USED INSTEAD. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2018: 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. 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. 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 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.
UPDATE RECEIVED 12DEC2018: 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/E3695363 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 |
|---|---|---|---|---|---|---|---|
| 682202 | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3731782 | 10827002449227 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death |