ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2010-00135
- Event Type
- Death
- Date Received
- May 21, 2010
- Date of Event
- April 23, 2010
- Report Date
- April 27, 2010
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- HDE H60001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
THE (B) (6) MALE WAS ADMITTED WITH A SUBARACHNOID HAEMORRHAGE (SAH) SUGGESTIVE OF A DISSECTING RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ANEURYSM UNDERWENT ENTERPRISE STENT ASSISTED COIL EMBOLIZATION. THERE WAS AN INTRAOPERATIVE RIGHT PICA PSEUDOANEURYSM RE-RUPTURE DURING COIL PLACEMENT AND EXTENSION OF RIGHT VERTEBRAL ARTERY (VA) DISSECTION RESISTANT TO CONTROL DESPITE USE OF STENT/COIL/BALLOON. THERE WAS MASSIVE SAH AND THE PATIENT SUBSEQUENTLY DIED. IT WAS REPORTED THAT THIS EVENT WAS NOT AT ALL RELATED TO THE ENTERPRISE STENT OR THE STENTING PROCEDURE, BUT RATHER TO THE COILING THAT FOLLOWED. PRELIMINARY DIAGNOSTIC RIGHT CEREBRAL VA ANGIOGRAPHY DEMONSTRATED MARKED IRREGULARITY OF THE INTRACRANIAL (V4) SEGMENT PROXIMAL AND DISTAL TO PICA CONSISTENT WITH DISSECTION WITH A 2-3MM BROAD-NECKED PSEUDOANEURYSM PARTIALLY INCORPORATING THE ORIGIN OF THE PICA. ANGIOGRAPHY CONFIRMED THE DIAGNOSIS OF RUPTURED DISSECTING RIGHT PICA PSEUDOANEURYSM AND RULED OUT ANY OTHER POTENTIAL SOURCE FOR THE SAH. THE DECISION WAS MADE TO PROCEED WITH STENT ASSISTED COIL EMBOLIZATION. DURING THE PROCEDURE, THE PROWLER SELECT PLUS WAS POSITIONED ACROSS THE PSEUDOANEURYSM NECK, WITH THE ENTERPRISE STENT (B) (4) PARTIALLY DEPLOYED DISTAL TO THE ANEURYSM BUT YET NOT DEPLOYED AT THE NECK. THE PSEUDOANEURYSM WAS THEN CATHETERIZED WITH THE PROWLER LP ES 45-DEGREE MICROCATHETER AND SYCHRO-2 STANDARD MICROWIRE. THE FIRST NON-CORDIS COIL WAS PARTIALLY EXTRUDED INTO THE PSEUDOANEURYSM, WITH PLAN TO THEN DEPLOY THE STENT AND COVER THE NECK OF THE ANEURYSM PRIOR TO DEPLOYING THE REST OF THE COIL. AT THIS POINT A SUDDEN CHANGE IN VITAL RAISED THE SUSPICION OF INTRAOPERATIVE ANEURYSM RUPTURE, WHICH WAS CONFIRMED ON THE SUBSEQUENT RUN. IMMEDIATELY, HEPARIN WAS REVERSED, AND COILS DEPLOYED, AND THE ENTERPRISE STENT WAS RELEASED TO BUTTRESS THE COILS AGAINST THE ANEURYSM. THE ANEURYSM CONTINUED TO LEAK AND A BALLOON WAS RAPIDLY BROUGHT UP TO TAMPONADE THE VESSEL, WHILE SIMULTANEOUSLY PLACING A RIGHT FRONTAL EXTERNAL VENTRICULAR DRAIN TO RELIEVE INTRACRANIAL PRESSURE. PROLONGED AND REPEATED ATTEMPTS AT BALLOON TAMPONADE AND PLACEMENT OF FURTHER COILS PROVED UNSUCCESSFUL AT SECURING THE ANEURYSM, AND THE PROCEDURE WAS TERMINATED. THE ACT RANGED FROM 162 TO 282 THROUGHOUT THE PROCEDURE. DURING THE PROCEDURE, HEPARIN BOLUSES WERE GIVEN OF 4000 AND THEN 1000 LATER ON. THE ENTERPRISE VRD REMAINS IMPLANTED AND THE DELIVERY SYSTEM IS NOT AVAILABLE FOR ANALYSIS. NOTE: LAKE REGION LOT NUMBER 01417603 IS CORDIS LOT NUMBER 13471800. PER LAKE REGION REPORT C 9,017: LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01417603 WHICH CORRESPONDS TO CORDIS ENTERPRISE LOT 13471800. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE PROWLER SELECT PLUS USED TO DELIVER THE ENTERPRISE VRD IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE FURTHER ANALYSIS CANNOT BE COMPLETED. THE PROWLER LPES MICROCATHETER USED FOR DELIVERY OF THE COIL IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE FURTHER ANALYSIS CANNOT BE COMPLETED. 3 CDS WITH IMAGES OF THE STENT-ASSISTED EMBOLIZATION PROCEDURE IN DICOM FORMAT WERE RECEIVED AND REVIEWED BY AN INDEPENDENT INTERVENTIONAL NEURORADIOLOGIST. THE IMAGES WERE EXTRACTED BY THE REVIEWER ALONG WITH THEIR FULL DICOM ATTRIBUTES IN ORDER TO ALLOW DIGITAL POST-PROCESSING. ALL IMAGES WERE OBTAINED ON THE INDEX PROCEDURE DATE. SERIES #01 IS TIMED AT 10:27:08 AM WHILE THE LAST SERIES ON THE CD, #47 WAS OBTAINED AT 14:32:47 PM. SERIES 01 TO 21 ARE DIAGNOSTIC ANGIOGRAMS. THEY INDICATE A SUBDOMINANT LEFT VERTEBRAL ARTERY AND A DOMINANT RIGHT VERTEBRAL ARTERY. THE LEFT VERTEBRAL ARTERY HAS SEVERE, OVER 70% MULTIFOCAL STENOSIS ALONG ITS INTRACRANIAL SEGMENT. THE STENOSIS IS PROXIMAL TO THE PICA ORIGIN. THE LVA FILLS THE LEFT PICA ONLY. SERIES 20 IMAGE 6 INDICATES 60% STENOSIS AT THE ORIGIN OF THE RIGHT VERTEBRAL ARTERY. THIS IS IMPORTANT ONLY BECAUSE THE GUIDE CATHETER MAY PARTIALLY BLOCK INFLOW ONCE ADVANCED TO THE RIGHT VERTEBRAL. PERFUSION VIA THE LEFT VERTEBRAL ARTERY ¿ ITSELF SEVERELY AFFECTED BY ATHEROSCLEROTIC DISEASE ¿ ALONG WITH THE REMNANT FLOW VIA THE RIGHT VERTEBRAL ARTERY SEEM TO BE SUFFICIENT TO MAINTAIN PERFUSION TO THE VERTEBROBASILAR SYSTEM. THERE IS A SMALL LEFT POSTERIOR COMMUNICATING ARTERY AND A SIMILARLY SMALL RIGHT PCOM. THREE-DIMENSIONAL RECONSTRUCTION INDICATES A SMALL WIDE NECK ANEURYSM AT THE RIGHT PICA ORIGIN. THERE IS A MILD ATHEROSCLEROTIC STENOSIS PROXIMAL TO THE ANEURYSM. THE RIGHT PICA IS AFFECTED BY SEVERE ATHEROSCLEROTIC DISEASE VS. VASOSPASM. ON THE LATERAL CONVENTIONAL VIEWS THERE IS A QUESTIONABLE FUSIFORM RIGHT PICA PERIMEDULLARY SEGMENT ANEURYSM, BUT THE 3D RECONSTRUCTION SUGGESTS THIS LESION TO BE A POST-STENOTIC DILATATION. DIAMETER MEASUREMENTS INDICATE RVA DIAMETERS TO VARY BETWEEN 2 AND 4 MM ALONG THE STENTED SEGMENT, PRE-STENT. MEASUREMENTS WERE DONE USING CALIBRATION INFORMATION FROM THE DICOM FILE. THE ANEURYSM MEASUREMENTS WERE: MAXIMUM WIDTH 4 MM; MAXIMUM HEIGHT 3 MM. SERIES #26 OBTAINED AT 12:50 PM INDICATES THE PRESENCE OF A LARGE CALIBER GUIDE CATHETER IN THE RIGHT VERTEBRAL ARTERY. THROUGH ITS LUMEN TWO MICROCATHETERS ARE SEEN ADVANCED. SERIES #27 AT 13:17 PM SHOWS THE SITUATION PRIOR TO THE ANEURYSM RUPTURE. THE ENTERPRISE DELIVERY SYSTEM IS ADVANCED ACROSS THE ANEURYSM NECK. THE DISTAL MARKERS ARE OPEN IN A NORMAL FASHION. THE PROXIMAL MARKERS ARE INSIDE THE CATHETER, CLOSED. THE MICROCATHETER DISTAL MARKER IS AT THE POINT OF ¿NO RETURN¿. A SINGLE LOOP OF PLATINUM COILS IS LOCATED INSIDE THE ANEURYSM. THE COIL DELIVERY CATHETER¿S DISTAL MARKER IS INSIDE THE ANEURYSM, IN AN APPROPRIATE POSITION. THERE IS NO SIGNIFICANT TENSION BUILT INTO THE CATHETER SYSTEM BASED ON THE POSITION OF THE CATHETERS. THE STENT IS ALREADY OPEN ACROSS THE ANEURYSM NECK; THE COIL IS READY TO BE FURTHER ADVANCED. ON SERIES #28 AT 13:20 PM THE SITUATION HAS CHANGED. MOST IMPORTANTLY THREE LOOPS OF THE COIL ARE SEEN, ONE OF THEM WIDELY PROTRUDING INTO THE SUBARACHNOID SPACE THROUGH THE RUPTURED DOME OF THE ANEURYSM. THE TIP OF THE COIL DELIVERY MICROCATHETER IS ALSO IN THE SUBARACHNOID SPACE, IT HAS MOVED FORWARD 2.82 MILLIMETERS. THE REVIEWER MEASURED THIS DISTANCE BY SUBTRACTING THE PRE-RUPTURE AND THE POST-RUPTURE IMAGES. THE SUBTRACTED IMAGES SHOWED CHANGES BETWEEN PRE-RUPTURE AND POST-RUPTURE WITH INCREASED LOOPING OF THE COIL DELIVERY MICROCATHETER AT C2 LEVEL, INDICATING INCREASED FORWARD-POINTING TENSION. IN ADDITION, THE FOLLOWING DIFFERENCES ARE SEEN WHEN SUBTRACTING SERIES # 47 AND 48: 1. THE STENT DELIVERY WIRE MOVED SLIGHTLY FORWARD. 2. THE DISTAL STENT MARKERS REMAINED IN THE EXACT SAME POSITION AS BEFORE. 3. THE PROXIMAL STENT MARKERS ARE NOW FULLY OPEN. 4. THE STENT DELIVERY CATHETER¿S MARKERS MOVED BACK ABOUT 10 MILLIMETERS (CONSISTENT WITH COMPLETED STENT DEPLOYMENT) 5. A SIGNIFICANT FORWARD-TENSION IS BUILT INTO THE COIL DELIVERY CATHETER SHAFT, INDICATED BY AN EXTRA CENTIMETER OR MORE EXCESS LOOP FORMATION AT C2 LEVEL. 6. THERE IS NO SIMILAR FORWARD-TENSION IN THE SHAFT OF THE STENT-DELIVERY MICROCATHETER. 7. THE WIRE OF THE STENT DELIVERY DEVICE IS SLIGHTLY MOVED FORWARD, THIS FINDING IN MY OPINION HAS NO RELEVANCE CONCERNING THE ANEURYSM RUPTURE. IT MERELY INDICATES SUCCESSFUL STENT DELIVERY. THE REVIEWER REPORTED THAT THE FOLLOWING CONCLUSIONS CAN BE DRAWN FROM THE ABOVE LIST OF EVENTS: 1. THE STENT DELIVERY WAS UNEVENTFUL, NO UNUSUAL MOVEMENT OR FORCES OF THE STENT DELIVERY SYSTEM ARE SEEN. 2. SIGNIFICANT FORWARD FORCE IS BUILT INTO THE COIL DELIVERY MICROCATHETER AFTER RUPTURE. THIS IS UNUSUAL BECAUSE NO SUCH FORWARD MOVEMENT OF THE MICROCATHETER IS GENERALLY EXPECTED OR ALLOWED DURING COILING OPERATIONS. 3. THE STENT WAS ALREADY OPEN ACROSS THE ANEURYSM NECK PRIOR TO THE RUPTURE. CONSEQUENTLY, ONE MAY NOT ARGUE THAT COMPLETED DELIVERY OF THE STENT RESULTED IN FORWARD MOVEMENT OF THE COIL DELIVERY CATHETER. 4. THE ANEURYSM DOME WAS PERFORATED BY BOTH THE COILS AND THE TIP OF THE MICROCATHETER. THE REVIEWER REPORTED AN INABILITY, BASED ON THE AVAILABLE IMAGES TO ANSWER THE QUESTION OF WHAT CAUSED THE RUPTURE. THERE IS NOT ENOUGH DATA ON THE EVENTS LEADING FROM THE SITUATION SEEN ON SERIES #27 TO SERIES #28. IT WAS REPORTED THAT THE REVIEWER CAN ONLY SPECULATE ON THEM. PER THE REVIEWER, ALTHOUGH IT WAS REPORTED THAT ¿THE FIRST COIL WAS PARTIALLY EXTRUDED INTO THE PSEUDOANEURYSM, WITH PLAN TO THEN DEPLOY THE STENT AND COVER THE NECK OF THE ANEURYSM¿¿ IN FACT THE STENT WAS ALREADY DEPLOYED PARTIALLY AND IT ALREADY COVERED THE ANEURYSM NECK EVEN BEFORE THE ANEURYSM RUPTURE. THE OPERATOR THEN DESCRIBES A SUDDEN CHANGE IN THE VITAL PARAMETERS, CONFIRMED ON THE SUBSEQUENT RUN, AND AFTER CONFIRMATION, ACTS WITH COUNTERMEASURES. IN FACT, SERIES #27 WAS FOLLOWED BY SERIES #28 (¿RUN¿). THERE IS ONLY 3 MINUTES DIFFERENCE BETWEEN RUN 27 AND 28, LEAVING ENOUGH TIME FOR CERTAIN MANIPULATIONS BUT NOT A LOT. THERE IS NO DOCUMENTED RUN BETWEEN 27 AND 28. AS IT IS DOCUMENTED, OBSERVATION OF EXTRAVASATION HAPPENED AFTER SOME MANIPULATION WITH BOTH THE COIL DELIVERY SYSTEM AND THE STENT DELIVERY SYSTEM. OF THE TWO, THE MANIPULATION WITH THE STENT DELIVERY SYSTEM WAS MILD AND NOT EXCEEDING NORMAL PROCEDURES, WHILE MANIPULATION WITH THE COIL DELIVERY SYSTEM WAS UNUSUAL, EXCESSIVE GIVEN THE SITUATION, AND MOST LIKELY RESULTED IN THE RUPTURE OF THE ANEURYSM. A COIL DELIVERY MICROCATHETER WOULD NOT BE INTENTIONALLY PUSHED FORWARD IN SUCH A DELICATE, BUT STABLE SITUATION. THE REVIEWER REPORTS THAT IT IS POSSIBLE, BUT PURE SPECULATION THAT WITHDRAWAL OF THE COIL DELIVERY MICROCATHETER DURING INTENDED STENT DELIVERY, BY WITHDRAWAL OF THE STENT MICROCATHETER, MAY HAVE REQUIRED RE-ADVANCEMENT OF THE COIL DELIVERY MICROCATHETER. IN THIS SCENARIO, RESISTANCE MAY HAVE BEEN ENCOUNTERED DUE TO THE ALREADY PARTIALLY OPENED STENT CAUSING THE MICROCATHETER TO JUMP FORWARD RESULTING IN ANEURYSM PERFORATION. HOWEVER, AS REPORTED BY THE REVIEWER, ¿THIS IS MERELY WILD SPECULATION¿. PER THE REVIEWER, THE ENTERPRISE STENT WAS MANIPULATED APPROPRIATELY AND THE STENT MOST LIKELY HAD NOTHING TO DO WITH THE COMPLICATION. IN ADDITION, THE REVIEWER SITES THAT WHILE ON SERIES #37, THE OCCLUSION BALLOON IS SEEN INFLATED NORMALLY, ON SERIES # 42 AND 43 THE PROXIMAL BALLOON DIAMETER IS EXCESSIVE, EXCEEDING 6 MILLIMETERS, CONSEQUENTLY, THE VERTEBRAL ARTERY AT THIS POINT MOST LIKELY RUPTURED AND DISINTEGRATED PROXIMALLY TO THE ANEURYSM NECK, STILL WITHIN THE STENT. IT IS NOTED THAT THE BALLOON IS BULGING EXCESSIVELY PROXIMAL TO THE ANEURYSM NECK, IN A LOCATION WHERE PRIOR TO THE ANEURYSM RUPTURE THE DIAMETER WAS MEASURED AS 2 MILLIMETERS. BASED ON THE AVAILABLE INFORMATION AND THE REVIEW OF PROVIDED IMAGES, THERE IS NO INDICATION THAT THE ENTERPRISE VRD AND DELIVERY SYSTEM OR THE PROWLER SELECT PLUS MICROCATHETER USED FOR STENT DELIVERY CAUSED THE ANEURYSM RUPTURE. VESSEL CHARACTERISTICS AND CLINICAL FACTORS RESULTING IN FORWARD TENSION BUILD UP APPEAR TO HAVE CONTRIBUTED TO THE FORWARD MOTION OF THE PROWLER SELECT LPES AND NONCORDIS RESULTING IN THE ANEURYSM RE-RUPTURE. ARTERIAL RUPTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANEURYSM EMBOLIZATION PROCEDURES AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFUS). THESE PROCEDURES ARE PERFORMED IN VESSELS WITH EXISTING ANEURYSMS AND KNOWN VESSEL WALL WEAKNESS. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED RUPTURE. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT # 1058196-2010-00135, 1058196-2010-00136, & 1058196-2010-00137.
THE (B) (6) MALE WAS ADMITTED WITH A SUBARACHNOID HAEMORRHAGE (SAH) SUGGESTIVE OF A DISSECTING RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ANEURYSM UNDERWENT ENTERPRISE STENT ASSISTED COIL EMBOLIZATION. THERE WAS AN INTRAOPERATIVE RIGHT PICA PSEUDOANEURYSM RE-RUPTURE DURING COIL PLACEMENT AND EXTENSION OF RIGHT VERTEBRAL ARTERY (VA) DISSECTION RESISTANT TO CONTROL DESPITE USE OF STENT/COIL/BALLOON. THERE WAS MASSIVE SAH AND THE PATIENT SUBSEQUENTLY DIED. IT WAS REPORTED THAT THIS EVENT WAS NOT AT ALL RELATED TO THE ENTERPRISE STENT OR THE STENTING PROCEDURE, BUT RATHER TO THE COILING THAT FOLLOWED. PRELIMINARY DIAGNOSTIC RIGHT CEREBRAL VA ANGIOGRAPHY DEMONSTRATED MARKED IRREGULARITY OF THE INTRACRANIAL (V4) SEGMENT PROXIMAL AND DISTAL TO PICA CONSISTENT WITH DISSECTION WITH A 2-3MM BROAD-NECKED PSEUDOANEURYSM PARTIALLY INCORPORATING THE ORIGIN OF THE PICA. ANGIOGRAPHY CONFIRMED THE DIAGNOSIS OF RUPTURED DISSECTING RIGHT PICA PSEUDOANEURYSM AND RULED OUT ANY OTHER POTENTIAL SOURCE FOR THE SAH. THE DECISION WAS MADE TO PROCEED WITH STENT ASSISTED COIL EMBOLIZATION. DURING THE PROCEDURE, THE PROWLER SELECT PLUS WAS POSITIONED ACROSS THE PSEUDOANEURYSM NECK, WITH THE ENTERPRISE STENT ((B) (4)) PARTIALLY DEPLOYED DISTAL TO THE ANEURYSM BUT YET NOT DEPLOYED AT THE NECK. THE PSEUDOANEURYSM WAS THEN CATHETERIZED WITH THE PROWLER LP ES 45-DEGREE MICROCATHETER AND SYNCHRO-2 STANDARD MICROWIRE. THE FIRST NON-CORDIS COIL WAS PARTIALLY EXTRUDED INTO THE PSEUDOANEURYSM, WITH PLAN TO THEN DEPLOY THE STENT AND COVER THE NECK OF THE ANEURYSM PRIOR TO DEPLOYING THE REST OF THE COIL. AT THIS POINT A SUDDEN CHANGE IN VITAL RAISED THE SUSPICION OF INTRAOPERATIVE ANEURYSM RUPTURE, WHICH WAS CONFIRMED ON THE SUBSEQUENT RUN. IMMEDIATELY, HEPARIN WAS REVERSED, AND COILS DEPLOYED, AND THE ENTERPRISE STENT WAS RELEASED TO BUTTRESS THE COILS AGAINST THE ANEURYSM. THE ANEURYSM CONTINUED TO LEAK AND A BALLOON WAS RAPIDLY BROUGHT UP TO TAMPONADE THE VESSEL, WHILE SIMULTANEOUSLY PLACING A RIGHT FRONTAL EXTERNAL VENTRICULAR DRAIN TO RELIEVE INTRACRANIAL PRESSURE. PROLONGED AND REPEATED ATTEMPTS AT BALLOON TAMPONADE AND PLACEMENT OF FURTHER COILS PROVED UNSUCCESSFUL AT SECURING THE ANEURYSM, AND THE PROCEDURE WAS TERMINATED. THE ACT RANGED FROM 162 TO 282 THROUGHOUT THE PROCEDURE. DURING THE PROCEDURE, HEPARIN BOLUSES WERE GIVEN OF 4000 AND THEN 1000 LATER ON. THE ENTERPRISE VRD REMAINS IMPLANTED AND THE DELIVERY SYSTEM IS NOT AVAILABLE FOR ANALYSIS. NOTE: LAKE REGION LOT NUMBER 01417603 IS CORDIS LOT NUMBER 13471800. PER LAKE REGION REPORT (B) (4): LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01417603 WHICH CORRESPONDS TO CORDIS ENTERPRISE LOT 13471800. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE PROWLER SELECT PLUS USED TO DELIVER THE ENTERPRISE VRD IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE FURTHER ANALYSIS CANNOT BE COMPLETED. THE PROWLER LPES MICROCATHETER USED FOR DELIVERY OF THE COIL IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE FURTHER ANALYSIS CANNOT BE COMPLETED. 3 CDS WITH IMAGES OF THE STENT-ASSISTED EMBOLIZATION PROCEDURE IN DICOM FORMAT WERE RECEIVED AND REVIEWED BY AN INDEPENDENT INTERVENTIONAL NEURORADIOLOGIST. THE IMAGES WERE EXTRACTED BY THE REVIEWER ALONG WITH THEIR FULL DICOM ATTRIBUTES IN ORDER TO ALLOW DIGITAL POST-PROCESSING. ALL IMAGES WERE OBTAINED ON THE INDEX PROCEDURE DATE. SERIES #01 IS TIMED AT 10:27:08 AM WHILE THE LAST SERIES ON THE CD, #47 WAS OBTAINED AT 14:32:47 PM. SERIES 01 TO 21 ARE DIAGNOSTIC ANGIOGRAMS. THEY INDICATE A SUBDOMINANT LEFT VERTEBRAL ARTERY AND A DOMINANT RIGHT VERTEBRAL ARTERY. THE LEFT VERTEBRAL ARTERY HAS SEVERE, OVER 70% MULTIFOCAL STENOSIS ALONG ITS INTRACRANIAL SEGMENT. THE STENOSIS IS PROXIMAL TO THE PICA ORIGIN. THE LVA FILLS THE LEFT PICA ONLY. SERIES 20 IMAGE 6 INDICATES 60% STENOSIS AT THE ORIGIN OF THE RIGHT VERTEBRAL ARTERY. THIS IS IMPORTANT ONLY BECAUSE THE GUIDE CATHETER MAY PARTIALLY BLOCK INFLOW ONCE ADVANCED TO THE RIGHT VERTEBRAL. PERFUSION VIA THE LEFT VERTEBRAL ARTERY ¿ ITSELF SEVERELY AFFECTED BY ATHEROSCLEROTIC DISEASE ¿ ALONG WITH THE REMNANT FLOW VIA THE RIGHT VERTEBRAL ARTERY SEEM TO BE SUFFICIENT TO MAINTAIN PERFUSION TO THE VERTEBROBASILAR SYSTEM. THERE IS A SMALL LEFT POSTERIOR COMMUNICATING ARTERY AND A SIMILARLY SMALL RIGHT PCOM. THREE-DIMENSIONAL RECONSTRUCTION INDICATES A SMALL WIDE NECK ANEURYSM AT THE RIGHT PICA ORIGIN. THERE IS A MILD ATHEROSCLEROTIC STENOSIS PROXIMAL TO THE ANEURYSM. THE RIGHT PICA IS AFFECTED BY SEVERE ATHEROSCLEROTIC DISEASE VS. VASOSPASM. ON THE LATERAL CONVENTIONAL VIEWS THERE IS A QUESTIONABLE FUSIFORM RIGHT PICA PERIMEDULLARY SEGMENT ANEURYSM, BUT THE 3D RECONSTRUCTION SUGGESTS THIS LESION TO BE A POST-STENOTIC DILATATION. DIAMETER MEASUREMENTS INDICATE RVA DIAMETERS TO VARY BETWEEN 2 AND 4 MM ALONG THE STENTED SEGMENT, PRE-STENT. MEASUREMENTS WERE DONE USING CALIBRATION INFORMATION FROM THE DICOM FILE. THE ANEURYSM MEASUREMENTS WERE: MAXIMUM WIDTH 4 MM; MAXIMUM HEIGHT 3 MM. SERIES #26 OBTAINED AT 12:50 PM INDICATES THE PRESENCE OF A LARGE CALIBER GUIDE CATHETER IN THE RIGHT VERTEBRAL ARTERY. THROUGH ITS LUMEN TWO MICROCATHETERS ARE SEEN ADVANCED. SERIES #27 AT 13:17 PM SHOWS THE SITUATION PRIOR TO THE ANEURYSM RUPTURE. THE ENTERPRISE DELIVERY SYSTEM IS ADVANCED ACROSS THE ANEURYSM NECK. THE DISTAL MARKERS ARE OPEN IN A NORMAL FASHION. THE PROXIMAL MARKERS ARE INSIDE THE CATHETER, CLOSED. THE MICROCATHETER DISTAL MARKER IS AT THE POINT OF ¿NO RETURN¿. A SINGLE LOOP OF PLATINUM COILS IS LOCATED INSIDE THE ANEURYSM. THE COIL DELIVERY CATHETER¿S DISTAL MARKER IS INSIDE THE ANEURYSM, IN AN APPROPRIATE POSITION. THERE IS NO SIGNIFICANT TENSION BUILT INTO THE CATHETER SYSTEM BASED ON THE POSITION OF THE CATHETERS. THE STENT IS ALREADY OPEN ACROSS THE ANEURYSM NECK; THE COIL IS READY TO BE FURTHER ADVANCED. ON SERIES #28 AT 13:20 PM THE SITUATION HAS CHANGED. MOST IMPORTANTLY THREE LOOPS OF THE COIL ARE SEEN, ONE OF THEM WIDELY PROTRUDING INTO THE SUBARACHNOID SPACE THROUGH THE RUPTURED DOME OF THE ANEURYSM. THE TIP OF THE COIL DELIVERY MICROCATHETER IS ALSO IN THE SUBARACHNOID SPACE, IT HAS MOVED FORWARD 2.82 MILLIMETERS. THE REVIEWER MEASURED THIS DISTANCE BY SUBTRACTING THE PRE-RUPTURE AND THE POST-RUPTURE IMAGES. THE SUBTRACTED IMAGES SHOWED CHANGES BETWEEN PRE-RUPTURE AND POST-RUPTURE WITH INCREASED LOOPING OF THE COIL DELIVERY MICROCATHETER AT C2 LEVEL, INDICATING INCREASED FORWARD-POINTING TENSION. IN ADDITION, THE FOLLOWING DIFFERENCES ARE SEEN WHEN SUBTRACTING SERIES # 47 AND 48: THE STENT DELIVERY WIRE MOVED SLIGHTLY FORWARD. THE DISTAL STENT MARKERS REMAINED IN THE EXACT SAME POSITION AS BEFORE. THE PROXIMAL STENT MARKERS ARE NOW FULLY OPEN. THE STENT DELIVERY CATHETER¿S MARKERS MOVED BACK ABOUT 10 MILLIMETERS (CONSISTENT WITH COMPLETED STENT DEPLOYMENT). A SIGNIFICANT FORWARD-TENSION IS BUILT INTO THE COIL DELIVERY CATHETER SHAFT, INDICATED BY AN EXTRA CENTIMETER OR MORE EXCESS LOOP FORMATION AT C2 LEVEL. THERE IS NO SIMILAR FORWARD-TENSION IN THE SHAFT OF THE STENT-DELIVERY MICROCATHETER. THE WIRE OF THE STENT DELIVERY DEVICE IS SLIGHTLY MOVED FORWARD, THIS FINDING IN MY OPINION HAS NO RELEVANCE CONCERNING THE ANEURYSM RUPTURE. IT MERELY INDICATES SUCCESSFUL STENT DELIVERY. THE REVIEWER REPORTED THAT THE FOLLOWING CONCLUSIONS CAN BE DRAWN FROM THE ABOVE LIST OF EVENTS: THE STENT DELIVERY WAS UNEVENTFUL, NO UNUSUAL MOVEMENT OR FORCES OF THE STENT DELIVERY SYSTEM ARE SEEN. SIGNIFICANT FORWARD FORCE IS BUILT INTO THE COIL DELIVERY MICROCATHETER AFTER RUPTURE. THIS IS UNUSUAL BECAUSE NO SUCH FORWARD MOVEMENT OF THE MICROCATHETER IS GENERALLY EXPECTED OR ALLOWED DURING COILING OPERATIONS. THE STENT WAS ALREADY OPEN ACROSS THE ANEURYSM NECK PRIOR TO THE RUPTURE. CONSEQUENTLY, ONE MAY NOT ARGUE THAT COMPLETED DELIVERY OF THE STENT RESULTED IN FORWARD MOVEMENT OF THE COIL DELIVERY CATHETER. THE ANEURYSM DOME WAS PERFORATED BY BOTH THE COILS AND THE TIP OF THE MICROCATHETER. THE REVIEWER REPORTED AN INABILITY, BASED ON THE AVAILABLE IMAGES TO ANSWER THE QUESTION OF WHAT CAUSED THE RUPTURE. THERE IS NOT ENOUGH DATA ON THE EVENTS LEADING FROM THE SITUATION SEEN ON SERIES #27 TO SERIES #28. IT WAS REPORTED THAT THE REVIEWER CAN ONLY SPECULATE ON THEM. PER THE REVIEWER, ALTHOUGH IT WAS REPORTED THAT ¿THE FIRST COIL WAS PARTIALLY EXTRUDED INTO THE PSEUDOANEURYSM, WITH PLAN TO THEN DEPLOY THE STENT AND COVER THE NECK OF THE ANEURYSM¿¿ IN FACT THE STENT WAS ALREADY DEPLOYED PARTIALLY AND IT ALREADY COVERED THE ANEURYSM NECK EVEN BEFORE THE ANEURYSM RUPTURE. THE OPERATOR THEN DESCRIBES A SUDDEN CHANGE IN THE VITAL PARAMETERS, CONFIRMED ON THE SUBSEQUENT RUN, AND AFTER CONFIRMATION, ACTS WITH COUNTERMEASURES. IN FACT, SERIES #27 WAS FOLLOWED BY SERIES #28 (¿RUN¿). THERE IS ONLY 3 MINUTES DIFFERENCE BETWEEN RUN 27 AND 28, LEAVING ENOUGH TIME FOR CERTAIN MANIPULATIONS BUT NOT A LOT. THERE IS NO DOCUMENTED RUN BETWEEN 27 AND 28. AS IT IS DOCUMENTED, OBSERVATION OF EXTRAVASATION HAPPENED AFTER SOME MANIPULATION WITH BOTH THE COIL DELIVERY SYSTEM AND THE STENT DELIVERY SYSTEM. OF THE TWO, THE MANIPULATION WITH THE STENT DELIVERY SYSTEM WAS MILD AND NOT EXCEEDING NORMAL PROCEDURES, WHILE MANIPULATION WITH THE COIL DELIVERY SYSTEM WAS UNUSUAL, EXCESSIVE GIVEN THE SITUATION, AND MOST LIKELY RESULTED IN THE RUPTURE OF THE ANEURYSM. A COIL DELIVERY MICROCATHETER WOULD NOT BE INTENTIONALLY PUSHED FORWARD IN SUCH A DELICATE, BUT STABLE SITUATION. THE REVIEWER REPORTS THAT IT IS POSSIBLE, BUT PURE SPECULATION THAT WITHDRAWAL OF THE COIL DELIVERY MICROCATHETER DURING INTENDED STENT DELIVERY, BY WITHDRAWAL OF THE STENT MICROCATHETER, MAY HAVE REQUIRED RE-ADVANCEMENT OF THE COIL DELIVERY MICROCATHETER. IN THIS SCENARIO, RESISTANCE MAY HAVE BEEN ENCOUNTERED DUE TO THE ALREADY PARTIALLY OPENED STENT CAUSING THE MICROCATHETER TO JUMP FORWARD RESULTING IN ANEURYSM PERFORATION. HOWEVER, AS REPORTED BY THE REVIEWER, ¿THIS IS MERELY WILD SPECULATION¿. PER THE REVIEWER, THE ENTERPRISE STENT WAS MANIPULATED APPROPRIATELY AND THE STENT MOST LIKELY HAD NOTHING TO DO WITH THE COMPLICATION. IN ADDITION, THE REVIEWER SITES THAT WHILE ON SERIES #37, THE OCCLUSION BALLOON IS SEEN INFLATED NORMALLY, ON SERIES # 42 AND 43 THE PROXIMAL BALLOON DIAMETER IS EXCESSIVE, EXCEEDING 6 MILLIMETERS, CONSEQUENTLY, THE VERTEBRAL ARTERY AT THIS POINT MOST LIKELY RUPTURED AND DISINTEGRATED PROXIMALLY TO THE ANEURYSM NECK, STILL WITHIN THE STENT. IT IS NOTED THAT THE BALLOON IS BULGING EXCESSIVELY PROXIMAL TO THE ANEURYSM NECK, IN A LOCATION WHERE PRIOR TO THE ANEURYSM RUPTURE THE DIAMETER WAS MEASURED AS 2 MILLIMETERS. BASED ON THE AVAILABLE INFORMATION AND THE REVIEW OF PROVIDED IMAGES, THERE IS NO INDICATION THAT THE ENTERPRISE VRD AND DELIVERY SYSTEM OR THE PROWLER SELECT PLUS MICROCATHETER USED FOR STENT DELIVERY CAUSED THE ANEURYSM RUPTURE. VESSEL CHARACTERISTICS AND CLINICAL FACTORS RESULTING IN FORWARD TENSION BUILD UP APPEAR TO HAVE CONTRIBUTED TO THE FORWARD MOTION OF THE PROWLER SELECT LPES AND NONCORDIS RESULTING IN THE ANEURYSM RE-RUPTURE. ARTERIAL RUPTURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANEURYSM EMBOLIZATION PROCEDURES AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFUS). THESE PROCEDURES ARE PERFORMED IN VESSELS WITH EXISTING ANEURYSMS AND KNOWN VESSEL WALL WEAKNESS. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED RUPTURE. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT # 1058196-2010-00135, 1058196-2010-00136, & 1058196-2010-00137.
ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF THE ANEURYSM RUPTURE WAS THAT THE ANEURYSM WAS PREVIOUSLY RUPTURED AND RE-RUPTURED DURING PLACEMENT OF FIRST COIL. THE ENTERPRISE STENT WAS PARTIALLY DEPLOYED DISTAL TO THE ANEURYSM BUT NOT AT ANEURYSM NECK. DURING THE PROCEDURE, THE ACT RANGED WAS FROM 162 TO 282 THROUGHOUT THE PROCEDURE. DURING THE PROCEDURE, HEPARIN BOLUSES WERE GIVEN OF 4000 AND THEN 1000 LATER ON DURING THE PROCEDURE. PRODUCTS UTILIZED DURING THE PROCEDURE: 6FRENCH SHEATH, 0.035" TERUMO GUIDEWIRE, 5FRENCH TERUMO SIM-2 DIAGNOSTIC CATHETER, PENUMBRA 105/8 0.070" GUIDE CATHETER, PROWLER LP ES 45 DEGREE AND PROWLER SELECT PLUS MICROCATHETER, SYNCHRO-2 STANDARD MICROWIRE, ENTERPRISE STENT 4.5X22MM, MICROSPHERE CERECYRE 2.5X3.3, MICROVENTION HYPERSOFT COIL 2X2 (X 3), AV3 HYPERFORM 4X7 BALLOON AND MYRX CLOSURE DEVICE. THIS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT # 1058196-2010-00135, 1058196-2010-00136, & 1058196-2010-00137. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE RELOADS DID NOT FIRE PROPERLY. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. (B)(6).
DEVICE 1 OF 2. REFERENCE MFR REPORT 1627487-2010-00847. THE PT RECEIVED HER SCS SYSTEM CONSISTING OF AN IPG, PADDLE LEADS, AND LEAD EXTENSIONS ON (B)(6) 2008. IT WAS REPORTED THAT THE PT HAD LOST STIMULATION FOR WHICH REPROGRAMMING DID NOT HELP. AN XRAY WAS TAKEN WHICH FOUND THE EXTENSIONS HAD COME OUT OF THE IPG HEADER WITH THE TERMINAL ENDS NOW LOCATED BEHIND THE IPG. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG AND EXTENSIONS ON (B)(6) 2008. THE EXPLANTED DEVICES WERE RETURNED TO ANS FOR EVALUATION. NO FURTHER INFO IS AVAILABLE.
THE PROWLER SELECT PLUS WAS POSITIONED ACROSS THE PSEUDOANEURYSM NECK, WITH THE ENTERPRISE STENT (B) (4) READY TO DEPLOY. THE PSEUDOANEURYSM WAS THEN CATHETERIZED WITH THE PROWLER LP ES 45-DEGREE MICROCATHETER AND SYCHRO-2 STANDARD MICROWIRE. THE FIRST NON-CORDIS COIL WAS PARTIALLY EXTRUDED INTO THE PSEUDOANEURYSM, WITH PLAN TO THEN DEPLOY THE STENT AND COVER THE NECK OF THE ANEURYSM PRIOR TO DEPLOYING THE REST OF THE COIL. AT THIS POINT A SUDDEN CHANGE IN VITAL RAISED THE SUSPICION OF INTRAOPERATIVE ANEURYSM RUPTURE, WHICH WAS CONFIRMED ON THE SUBSEQUENT RUN. IMMEDIATELY, HEPARIN WAS REVERSED, AND COILS DEPLOYED, AND RELEASE THE ENTERPRISE STENT TO BUTTRESS THE COILS AGAINST THE ANEURYSM. THE ANEURYSM CONTINUED TO LEAK AND NON-CORDIS BALLOON WAS RAPIDLY BROUGHT UP TO TAMPONADE THE VESSEL, WHILE SIMULTANEOUSLY PLACING A RIGHT FRONTAL EXTERNAL VENTRICULAR DRAIN TO RELIVE INTRACRANIAL PRESSURE. PROLONGED AND REPEATED ATTEMPTS AT BALLOON TAMPONADE AND PLACEMENT OF FURTHER NON CORDIS COILS PROVED UNSUCCESSFUL AT SECURING THE ANEURYSM, AND THE PROCEDURE WAS TERMINATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | 13471800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Death| R |