ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
Report
- Report Number
- 3002808486-2022-00285
- Event Type
- Death
- Date Received
- May 4, 2022
- Date of Event
- April 12, 2022
- Report Date
- September 21, 2022
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002448596
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS.
MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ON (B)(6) 2022 A 75-YEAR-OLD FEMALE UNDERWENT TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) FOR A DISSECTING AORTIC ANEURYSM WITH THE ENTRY ON THE DISTAL SIDE OF PREVIOUSLY REPLACED ASCENDING AORTA AND AORTA ARCH. THE DIAMETER OF THE DESCENDING AORTIC ANEURYSM WAS ABOUT 70 MM. THE PATIENT UNDERWENT A STENT GRAFT INSERTION PROCEDURE TO CLOSE THE ENTRY AND PREVENT THE DISSECTING AORTIC ANEURYSM FROM RUPTURING. WITH AN INTRAOPERATIVE BLOOD PRESSURE OF 80 MMHG, ZTA-PT-32-28-178-W1 (COMPLAINT DEVICE) WAS PLACED IN THE ARTIFICIAL VESSEL IN THE AORTIC ARCH AND THE DISTAL SIDE OF THE LEFT SUBCLAVIAN ARTERY FOR THE PURPOSE OF ENTRY CLOSURE. AFTER CLOSURE OF THE ENTRY, BLOOD PRESSURE WAS ABOUT 45-55 MMHG, AND A GORE VBX WAS PLACED TO CLOSE THE RE-ENTRY IN THE LEFT EXTERNAL ILIAC ARTERY. AFTER ANGIOGRAPHY WAS PERFORMED TO PERFORM THE SAME PROCEDURE ON THE RIGHT EXTERNAL ILIAC ARTERY, BLOOD PRESSURE DROPPED TO 20-30 MMHG AND CARDIAC FUNCTION WAS DECREASED. IT WAS APPROXIMATELY 20 MINUTES AFTER STENT GRAFT PLACEMENT. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS USED TO CHECK IF CARDIAC TAMPONADE OCCURRED, BUT IT WAS NOT CONFIRMED. NO PERFORATION NOR BLEEDING WERE CONFIRMED. MEDICAL THERAPY AND CARDIAC MASSAGE INCLUDING DEFIBRILLATION WERE PERFORMED. THE PATIENT WAS INITIALLY PUT ON PCPS (PERCUTANEOUS CARDIOPULMONARY SUPPORT) AND THEN ON ECMO (EXTRA CORPORAL MEMBRANE OXYGENATION) BUT EXPIRED ON (B)(6) 2022 DUE TO DECREASED BLOOD PRESSURE. AUTOPSY WAS NOT CONDUCTED. THE PATIENT HAD PRE-EXISTING AORTIC VALVE REFLUX DISEASE. THE PHYSICIAN STATED, THAT ¿IT IS QUESTIONABLE WHETHER AN AORTIC VALVE EVENT ALONE COULD HAVE CAUSED THIS CONDITION¿. BUT ALSO NOTED, ¿¿IT IS POSSIBLE THAT THE INTERFERENCE (POKING) TO THE AORTIC VALVE WITH THE DELIVERY SYSTEM OF THE ZTA MADE THE HEART SITUATION WORSE, BUT WITHOUT AN AUTOPSY, IT IS IMPOSSIBLE TO SAY FOR SURE¿. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. SIX IMAGES FROM THE 3MENSIO PLANNING WORKSHEET ARE PROVIDED AND REVIEWED ALONG WITH THE COMPLAINT REPORT BY CRI ON (B)(6) 2022. NO PRODUCT WAS RETURNED. PER THE FINDINGS IN THE IMAGING REVIEW: ¿THE COMPLAINT CONCERNS HYPOTENSIVE CARDIAC ARREST AFTER ZTA-PT-32-28-178-W1 IMPLANTATION. THE REPORT SPECULATES THAT INTRODUCER TIP INTERFERENCE WITH THE AORTIC VALVE WORSENED PREEXISTING AORTIC REGURGITATION. SPECULATION AS TO HOW TEMPORARY AORTIC VALVE INTERFERENCE COULD HAVE LED TO THE PROLONGED AND PROGRESSIVE HYPOTENSION WAS NOT PROVIDED. THE ZTA-P WAS IMPLANTED 30MM INSIDE OF A PRE-EXISTING ARCH REPLACEMENT TO SEAL THE ENTRY SITE OF A 7CM DIAMETER DESCENDING THORACIC AORTIC DISSECTION ANEURYSM. THE DISSECTION ENTRY SITE WAS REPORTEDLY CLOSE TO THE GRAFT¿S ANASTOMOSIS TO THE THORACIC AORTA. THE ANASTOMOSIS WAS AT WHAT WOULD HAVE BEEN THE PRIOR LOCATION OF THE AORTIC ARCH APEX. AN ELEPHANT TRUNK WAS NOT PRESENT. THE ZTA-P WAS INSERTED JUST DISTAL THE ARCH REPLACEMENT GRAFT BRANCHES. SINCE THESE ORIGINATED IN THE LOCATION OF THE ONCE NORMAL ASCENDING AORTA, DELIVERY OF THE ZTA-P TO THE TARGET LOCATION REQUIRED ADVANCEMENT TO WHAT ORIGINALLY WAS THE ASCENDING AORTA¿S LOCATION. THIS WAS APPROXIMATELY 73MM SUPERIOR THE AORTIC VALVE ANNULUS.(FIGURE 1). THE INTRODUCER TIP WOULD HAVE PASSED THROUGH THE AORTIC VALVE AT EITHER THE RIGHT OR LEFT VALVE LEAFLETS BY APPROXIMATELY 2CM. SUBJECTIVELY THE SINUSES OF VALSALVA WERE RELATIVELY SHALLOW. CONSEQUENTLY THE CORONARY ARTERY OSTIA, PARTICULARLY THE RIGHT, WERE LIKELY VULNERABLE TO INTERFERENCE FROM A DISPLACED VALVE LEAFLET. THE ZTA-P TERMINATED IN A COMPRESSED GENERALLY D SHAPED 10.5 MM X 27.1 MM FALSE LUMEN. BILATERAL ILIAC ARTERY DISTAL ENTRY SITES REPORTEDLY WERE TREATED WITH GORE VBX STENTS. THE RIGHT AND LEFT ILIAC ARTERY DIAMETERS WERE SUFFICIENT FOR DELIVERY SYSTEM INTRODUCTION. THE BLOOD PRESSURE WAS INTENTIONALLY DECREASED TO 80MMHG SYSTOLIC TO FACILITATE ENDOGRAFT IMPLANTATION. 20 MINUTES POST IMPLANTATION, THE SYSTOLIC BLOOD PRESSURE HAD DROPPED TO 20-30MM HG. DESPITE CRP AND EPINEPHRINE, THE HEART WAS REPORTED IN NEAR ARREST. CARDIAC TAMPONADE WAS EXCLUDED. THE PATIENT WAS SUBSEQUENTLY PLACED ON PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). CARDIAC CONTRACTIONS RECOVERED TWO DAYS LATER ALLOWING THE PATIENT TO BE PLACED ON ECMO RATHER THAN PCPS. A DAY LATER THE PATIENT EXPIRED FROM HYPOTENSION. THE POSSIBILITY OF AORTIC VALVE INTERFERENCE WAS NOTED ON THE PLANNING AND SIZING WORKSHEET AND DISCUSSED WITH THE PATIENT PRIOR TO THE PROCEDURE. WHETHER THIS IMPLIED AORTIC VALVE INJURY OR CORONARY ARTERY OSTIAL COMPROMISE WAS NOT REPORTED.¿ PER THE IMPRESSION IN THE IMAGING REVIEW: ¿THE IMAGING CONFIRMS THAT INTRODUCER MUST HAVE CROSSED THE AORTIC VALVE. WHETHER THE CROSSING RESULTED IN HYPOTENSION IS NOT CONFIRMED. THE ONLY REPORTED EXCLUDED CAUSE WAS CARDIAC TAMPONADE. HYPOTENSION WOULD HAVE BEEN THE RESULT OF BLEEDING, MYOCARDIAL INFARCTION, SEVERE AORTIC REGURGITATION, OR A COMBINATION THESE. INFORMATION REGARDING ANY WORKUP OF THESE ETIOLOGIES WAS NOT PROVIDED.¿ PER THE CLINICAL ASSESSMENT MADE BY A MEDICAL ADVISER: ¿BASED ON THE INFORMATION IT IS NOT POSSIBLE TO ESTABLISH AN EXACT CAUSE. IT SEEMS POSSIBLE THAT A POTENTIAL INTERFERENCE BETWEEN THE ALREADY DISEASED AORTIC VALVE AND THE DELIVERY SYSTEM COULD HAVE CONTRIBUTED TO THE EVENT, BUT THIS IS ONLY SPECULATIVE GIVEN NO AVAILABLE INFORMATION CAN CONFIRM IT. THERE ARE NO INDICATIONS ON FAULT DEVICE. THE SEVERITY IS 10 GIVEN THAT THE OUTCOME WAS PATIENT DEATH. BUT AS STATED ABOVE NO CAUSAL RELATIONSHIP TO THE DEVICE IS POSSIBLE. IT SHOULD BE NOTED THAT THE DEVICE WAS USED IN A DISSECTING ANEURYSM AND IN COMBINATION WITH AN ARTIFICIAL VESSEL.¿ THE IFU CLEARLY STATES THAT THE DEVICE IS NOT INDICATED FOR TREATMENT OF PATIENTS WITH DISSECTIONS. FURTHERMORE THE SAFETY AND EFFECTIVENESS OF THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT AND ANCILLARY COMPONENTS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: ACCESS VESSELS THAT PRECLUDE SAFE INSERTION. BASED ON THE PROVIDED INFORMATION IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE CAUSE OF THE REPORTED EVENT. HOWEVER, ITS POSSIBLE THAT THE PATIENTS PRE-EXISTING CONDITIONS AND THE ADVANCEMENT PROCEDURE COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE THE DEVICE WAS USED OFF-LABEL. COOK WILL REOPEN THE COMPLAINT IF FURTHER INFORMATION IS RECEIVED. 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.
MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ON (B)(6) 2022 A 75-YEAR-OLD FEMALE UNDERWENT TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) FOR A DISSECTING AORTIC ANEURYSM WITH THE ENTRY ON THE DISTAL SIDE OF PREVIOUSLY REPLACED ASCENDING AORTA AND AORTA ARCH. THE DIAMETER OF THE DESCENDING AORTIC ANEURYSM WAS ABOUT 70 MM. THE PATIENT UNDERWENT A STENT GRAFT INSERTION PROCEDURE TO CLOSE THE ENTRY AND PREVENT THE DISSECTING AORTIC ANEURYSM FROM RUPTURING. WITH AN INTRAOPERATIVE BLOOD PRESSURE OF 80 MMHG, ZTA-PT-32-28-178-W1 (COMPLAINT DEVICE) WAS PLACED IN THE ARTIFICIAL VESSEL IN THE AORTIC ARCH AND THE DISTAL SIDE OF THE LEFT SUBCLAVIAN ARTERY FOR THE PURPOSE OF ENTRY CLOSURE. AFTER CLOSURE OF THE ENTRY, BLOOD PRESSURE WAS ABOUT 45-55 MMHG, AND A GORE VBX WAS PLACED TO CLOSE THE RE-ENTRY IN THE LEFT EXTERNAL ILIAC ARTERY. AFTER ANGIOGRAPHY WAS PERFORMED TO PERFORM THE SAME PROCEDURE ON THE RIGHT EXTERNAL ILIAC ARTERY, BLOOD PRESSURE DROPPED TO 20-30 MMHG AND CARDIAC FUNCTION WAS DECREASED. IT WAS APPROXIMATELY 20 MINUTES AFTER STENT GRAFT PLACEMENT. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS USED TO CHECK IF CARDIAC TAMPONADE OCCURRED, BUT IT WAS NOT CONFIRMED. NO PERFORATION NOR BLEEDING WERE CONFIRMED. MEDICAL THERAPY AND CARDIAC MASSAGE INCLUDING DEFIBRILLATION WERE PERFORMED. THE PATIENT WAS INITIALLY PUT ON PCPS (PERCUTANEOUS CARDIOPULMONARY SUPPORT) AND THEN ON ECMO (EXTRA CORPORAL MEMBRAN OXYGENATION) BUT EXPIRED ON (B)(6) 2022 DUE TO DECREASED BLOOD PRESSURE. AUTOPSY WAS NOT CONDUCTED. THE PATIENT HAD PRE-EXISTING AORTIC VALVE REFLUX DISEASE. THE PHYSICIAN STATED, THAT ¿IT IS QUESTIONABLE WHETHER AN AORTIC VALVE EVENT ALONE COULD HAVE CAUSED THIS CONDITION¿. BUT ALSO NOTED, ¿¿IT IS POSSIBLE THAT THE INTERFERENCE (POKING) TO THE AORTIC VALVE WITH THE DELIVERY SYSTEM OF THE ZTA MADE THE HEART SITUATION WORSE, BUT WITHOUT AN AUTOPSY, IT IS IMPOSSIBLE TO SAY FOR SURE¿. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. SIX IMAGES FROM THE 3MENSIO PLANNING WORKSHEET ARE PROVIDED AND REVIEWED ALONG WITH THE COMPLAINT REPORT BY CRI ON 08AUG2022. NO PRODUCT WAS RETURNED. PER THE FINDINGS IN THE IMAGING REVIEW: ¿THE COMPLAINT CONCERNS HYPOTENSIVE CARDIAC ARREST AFTER ZTA-PT-32-28-178-W1 IMPLANTATION. THE REPORT SPECULATES THAT INTRODUCER TIP INTERFERENCE WITH THE AORTIC VALVE WORSENED PREEXISTING AORTIC REGURGITATION. SPECULATION AS TO HOW TEMPORARY AORTIC VALVE INTERFERENCE COULD HAVE LED TO THE PROLONGED AND PROGRESSIVE HYPOTENSION WAS NOT PROVIDED. THE ZTA-P WAS IMPLANTED 30MM INSIDE OF A PRE-EXISTING ARCH REPLACEMENT TO SEAL THE ENTRY SITE OF A 7CM DIAMETER DESCENDING THORACIC AORTIC DISSECTION ANEURYSM. THE DISSECTION ENTRY STIE WAS REPORTEDLY CLOSE TO THE GRAFT¿S ANASTOMOSIS TO THE THORACIC AORTA. THE ANASTOMOSIS WAS AT WHAT WOULD HAVE BEEN THE PRIOR LOCATION OF THE AORTIC ARCH APEX. AN ELEPHANT TRUNK WAS NOT PRESENT. THE ZTA-P WAS INSERTED JUST DISTAL THE ARCH REPLACEMENT GRAFT BRANCHES. SINCE THESE ORIGINATED IN THE LOCATION OF THE ONCE NORMAL ASCENDING AORTA, DELIVERY OF THE ZTA-P TO THE TARGET LOCATION REQUIRED ADVANCEMENT TO WHAT ORIGINALLY WAS THE ASCENDING AORTA¿S LOCATION. THIS WAS APPROXIMATELY 73MM SUPERIOR THE AORTIC VALVE ANNULUS. THE INTRODUCER TIP WOULD HAVE PASSED THROUGH THE AORTIC VALVE AT EITHER THE RIGHT OR LEFT VALVE LEAFLETS BY APPROXIMATELY 2CM. SUBJECTIVELY THE SINUSES OF VALSALVA WERE RELATIVELY SHALLOW. CONSEQUENTLY THE CORONARY ARTERY OSTIA, PARTICULARLY THE RIGHT, WERE LIKELY VULNERABLE TO INTERFERENCE FROM A DISPLACED VALVE LEAFLET. THE ZTA-P TERMINATED IN A COMPRESSED GENERALLY D SHAPED 10.5 MM X 27.1 MM FALSE LUMEN. BILATERAL ILIAC ARTERY DISTAL ENTRY SITES REPORTEDLY WERE TREATED WITH GORE VBX STENTS. THE RIGHT AND LEFT ILIAC ARTERY DIAMETERS WERE SUFFICIENT FOR DELIVERY SYSTEM INTRODUCTION. THE BLOOD PRESSURE WAS INTENTIONALLY DECREASED TO 80MMHG SYSTOLIC TO FACILITATE ENDOGRAFT IMPLANTATION. 20 MINUTES POST IMPLANTATION, THE SYSTOLIC BLOOD PRESSURE HAD DROPPED TO 20-30MM HG. DESPITE CRP AND EPINEPHRINE, THE HEART WAS REPORTED IN NEAR ARREST. CARDIAC TAMPONADE WAS EXCLUDED. THE PATIENT WAS SUBSEQUENTLY PLACED ON PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). CARDIAC CONTRACTIONS RECOVERED TWO DAYS LATER ALLOWING THE PATIENT TO BE PLACED ON ECMO RATHER THAN PCPS. A DAY LATER THE PATIENT EXPIRED FROM HYPOTENSION. THE POSSIBILITY OF AORTIC VALVE INTERFERENCE WAS NOTED ON THE PLANNING AND SIZING WORKSHEET AND DISCUSSED WITH THE PATIENT PRIOR TO THE PROCEDURE. WHETHER THIS IMPLIED AORTIC VALVE INJURY OR CORONARY ARTERY OSTIAL COMPROMISE WAS NOT REPORTED.¿ PER THE IMPRESSION IN THE IMAGING REVIEW: ¿THE IMAGING CONFIRMS THAT INTRODUCER MUST HAVE CROSSED THE AORTIC VALVE. WHETHER THE CROSSING RESULTED IN HYPOTENSION IS NOT CONFIRMED. THE ONLY REPORTED EXCLUDED CAUSE WAS CARDIAC TAMPONADE. HYPOTENSION WOULD HAVE BEEN THE RESULT OF BLEEDING, MYOCARDIAL INFARCTION, SEVERE AORTIC REGURGITATION, OR A COMBINATION THESE. INFORMATION REGARDING ANY WORKUP OF THESE ETIOLOGIES WAS NOT PROVIDED.¿ PER THE CLINICAL ASSESSMENT MADE BY A MEDICAL ADVISER: ¿BASED ON THE INFORMATION IT IS NOT POSSIBLE TO ESTABLISH AN EXACT CAUSE. IT SEEMS POSSIBLE THAT A POTENTIAL INTERFERENCE BETWEEN THE ALREADY DISEASED AORTIC VALVE AND THE DELIVERY SYSTEM COULD HAVE CONTRIBUTED TO THE EVENT, BUT THIS IS ONLY SPECULATIVE GIVEN NO AVAILABLE INFORMATION CAN CONFIRM IT. THERE ARE NO INDICATIONS ON FAULT DEVICE. THE SEVERITY IS 10 GIVEN THAT THE OUTCOME WAS PATIENT DEATH. NO CAUSAL RELATIONSHIP TO THE DEVICE IS POSSIBLE. IT SHOULD BE NOTED THAT THE DEVICE WAS USED IN A DISSECTING ANEURYSM AND IN COMBINATION WITH AN ARTIFICIAL VESSEL.¿ THE IFU CLEARLY STATES THAT THE DEVICE IS NOT INDICATED FOR TREATMENT OF PATIENTS WITH DISSECTIONS. FURTHERMORE STRICT ADHERENCE TO THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IFU SIZING GUIDE BOTH IN TERMS OF COMPONENT DIAMETER AS WELL AS COMPONENT TYPE/LENGTH IS STRONGLY RECOMMENDED IN ORDER TO MITIGATE THE RISK FOR EVENTS (E.G., MIGRATION, ENDOLEAK, ANEURYSM GROWTH) THAT COULD RESULT FROM SELECTING INAPPROPRIATE DEVICE SIZES. BASED ON THE PROVIDED INFORMATION IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE CAUSE OF THE REPORTED EVENT. COOK WILL REOPEN THE COMPLAINT IF FURTHER INFORMATION IS RECEIVED. 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: THIS WAS A CASE OF DISSECTING AORTIC ANEURYSM WITH THE ENTRY ON THE DISTAL SIDE OF PREVIOUSLY REPLACED ASCENDING AORTA AND AORTA ARCH, AND THE DESCENDING AORTA WAS ABOUT 70 MM. THE PATIENT UNDERWENT A STENT GRAFT INSERTION PROCEDURE TO CLOSE THE ENTRY AND PREVENT THE DISSECTING AORTIC ANEURYSM FROM RUPTURING. WITH AN INTRAOPERATIVE BLOOD PRESSURE OF 80 MMHG, ZTA-PT-32-28-178-W1 WAS PLACED IN THE ARTIFICIAL VESSEL IN THE AORTA ARCH AND THE DISTAL SIDE OF THE LEFT SUBCLAVIAN ARTERY FOR THE PURPOSE OF ENTRY CLOSURE. AFTER CLOSURE OF THE ENTRY, BLOOD PRESSURE WAS ABOUT 45-55 MMHG, AND A GORE'S VBX (10 MM IN DIAMETER AND 39 MM IN LENGTH) WAS PLACED TO CLOSE THE RE-ENTRY IN THE LEFT EXTERNAL ILIAC ARTERY. AFTER ANGIOGRAPHY WAS PERFORMED TO PERFORM THE SAME PROCEDURE ON THE RIGHT EXTERNAL ILIAC ARTERY, BLOOD PRESSURE DROPPED TO 20-30 MMHG AND CARDIAC FUNCTION WAS DECREASED. IT WAS APPROX 20 MINUTES AFTER STENT GRAFT PLACEMENT. BOSMIN WAS ADMINISTERED AND CARDIAC MASSAGE WAS CONTINUED CONSTANTLY. TRANSESOPHAGEAL ECHOCARDIOGRAPHY WAS USED TO CHECK IF CARDIAC TAMPONADE OCCURRED, BUT IT WAS NOT CONFIRMED. THE HEART WAS IN NEAR CARDIAC ARREST AND SHE ALIVES USING PCPS. DCS WAS PERFORMED TWICE AS WELL. THE PATIENT IS STILL ALIVE BY PCPS, BUT HER OWN CARDIAC FUNCTION HAS NOT RECOVERED. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022: NO PERFORATION NOR BLEEDING WERE CONFIRMED. EVEN IF THE TIP OF THE DELIVERY SYSTEM ACTUALLY POKED THE AORTIC VALVE, IT'S UNKNOWN WHAT WAS CAUSED BY POKING. THE CAUSE OF DECREASING BLOOD PRESSURE AND CARDIAC FUNCTION IS NOT CONFIRMED AS OF TODAY. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022: THE PATIENT WAS TAKEN OFF THE PCPS AND NOW SHE IS ON ECMO. PATIENT OUTCOME: THE PATIENT DECEASED ON (B)(6) 2022 DUE TO DECREASED BLOOD PRESSURE. AUTOPSY WAS NOT CONDUCTED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
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 |
|---|---|---|---|---|---|---|---|
| 1804022 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E4131768 | 10827002448596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Death |