PULSERIDER Y, 4MM, 8MM ARCH
Report
- Report Number
- 3008680601-2018-00556
- Event Type
- Injury
- Date Received
- October 10, 2018
- Date of Event
- September 20, 2018
- Report Date
- September 20, 2018
- Manufacturer
- PULSAR VASCULAR
- Product Code
- NJE
- UDI-DI
- 00859030005109
- PMA / PMN Number
- H160002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURER¿S REF. NO: (B)(4). ADDITIONAL INFORMATION RECEIVED FROM PHYSICIAN REVIEW OF PROCEDURE IMAGES AND PROCEDURE REPORT ON 10/10/2018. DATE OF REVIEW: OCTOBER 10, 2018. INFORMATION REVIEWED: OPERATIVE NOTE AND MULTIPLE ANGIOGRAPHIC IMAGES OF THE PROCEDURE, INCLUDING PRE, INTRA-OP, AND POST PROCEDURE. SUMMARY: THERE IS CLEARLY A PSEUDOANEURYSM ARISING FROM THE RIGHT SCA JUST DISTAL TO THE ORIGIN THAT WAS NOT PRESENT PRIOR TO PLACEMENT OF THE DEVICES. IT LOOKS LIKE IT ISN¿T ARISING FROM THE BASILAR BUT TRULY THE SCA ABOUT 1-2 MM FROM THE ACTUAL ORIGIN. I DON¿T SEE ANY IMAGES OF THE PULSERIDER IN THE SCA, ANY OTHER DEVICES IN THE RIGHT SCA. I THINK THIS COULD HAVE OCCURRED EITHER FROM INADVERTENT PLACEMENT OF THE PULSE RIDER LEAFLETS IN THE RIGHT SCA, EVEN A PARTIAL DEPLOYMENT, OR FROM A MICROWIRE PERFORATION DURING NAVIGATION OF ANY OF THE CATHETERS. THERE IS NO MENTION OF ANY DEVICE (PULSE RIDER OR MICROWIRE) ENTERING THE RIGHT SCA AT ANY TIME IN THE OPERATIVE REPORT. IN GENERAL, THE PSEUDOANEURYSM DEPICTED IN THE CASE MOST LIKELY CAN ONLY BE CAUSED FROM PHYSICAL TRAUMA IN MY EXPERT OPINION, SO EITHER THE DEVICE WAS AT ONE POINT DEPLOYING IN THE SCA OR THERE WAS A MICROWIRE PERFORATION. I DO NOT THINK IT IS LIKELY THIS PSEUDOANEURYSM CAN BE CAUSED BY THE STEM OF THE PULSERIDER DEVICE, OR THE DEVICE ITSELF IF IT NEVER ENTERED THE SCA (FOR EXAMPLE I DO NOT BELIEVE A PROPERLY PLACED DEVICE WOULD HAVE PUT ENOUGH PRESSURE OR TORQUE ON THE BASILAR OR SCA ARTERY TO CAUSE THIS PSEUDOANEURYSM). THE STROKE PROGRAM MANAGER REPORTED THAT AS OF 10/10/2018, THE PATIENT REMAINS COMATOSE WITH A GLASGOW COMA SCALE (GCS) SCORE OF 6 AND IS UNDER S/P TRACHEOSTOMY; THE PATIENT IS UNABLE TO BE WEANED OFF THE VENTRICULOSTOMY YESTERDAY. A SHUNT PLACEMENT IS BEING CONSIDERED AT THIS TIME. THERE HAVE BEEN NO NEUROLOGICAL CHANGES. THE PATIENT DOES NOT FOLLOW COMMANDS OR MOVE SPONTANEOUS BUT DOES HAVE DECORTICATE POSTURING ON DEEP NOXIOUS SQUEEZE. THE PATIENT IS HEMODYNAMICALLY STABLE. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008680601-2018-00557. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. CONCOMITANT MED PRODUCTS: GALAXY G3 COILS, PROWLER LPES MICROCATHETER, PROWLER SELECT PLUS MICROCATHETER. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT A (B)(6) FEMALE PATIENT PRESENTED WITH AN ANEURYSM FROM THE TOP OF THE BASILAR ARTERY ON NEUROIMAGING STUDIES THAT WAS DONE IN WORK UP AFTER EXPERIENCING A 3-DAY HISTORY OF CONFUSION IN (B)(6) 2018. THE PATIENT UNDERWENT SELECTIVE ANGIOGRAPHY ON (B)(6) 2018, THAT DEMONSTRATED A SMALL, BROAD-BASED ANEURYSM MEASURING 1.8MM X 3.5MM FROM THE TOP OF THE BASILAR ARTERY, PROJECTING SUPERIORLY AND SLIGHTLY TO THE LEFT. THE BASE OF THE ANEURYSM WAS OFFSET TO THE LEFT TO MORE INVOLVE THE COMMON ORIGIN OF THE LEFT POSTERIOR CEREBRAL SUPERIOR CEREBELLAR ARTERIES. A MILD FOCAL NARROWING WAS NOTED AT THE DISTAL BASILAR ARTERY. ELECTIVE TREATMENT WAS RECOMMENDED GIVEN THE SIZE AND LOCATION OF THE ANEURYSM. THE PATIENTLY REPORTEDLY DECLINED NEUROSURGICAL REFERRAL FOR CLIP LIGATION CONSIDERATION; ENDOVASCULAR APPROACH WITH RECONSTRUCTION OF THE ANEURYSM NECK WAS OFFERED USING EITHER THE NEUROFORM STENT OR THE PULSERIDER DEVICES WAS OFFERED. WITH THE LESION LOCATION AT THE DISTAL BASILAR ARTERY, THE PULSERIDER DEVICE WAS CHOSEN. THE PATIENT WAS STARTED ON DUAL ANTIPLATELET THERAPY PRIOR TO THE PULSERIDER PROCEDURE. THE PULSERIDER PROCEDURE TOOK PLACE ON (B)(6) 2018, THE PHYSICIAN SELECTED THE PULSERIDER Y, 4MM, 8MM ARCH (303D / W2618-07). THE PULSERIDER Y DEVICE WAS ADVANCED THROUGH THE PROWLER SELECT PLUS (606S255X). THE DEVICE WAS ADVANCED GENTLY BEYOND THE MICROCATHETER TIP FRONTAL AND THE 4 DISTAL MARKERS WERE SEEN FLOWERED OUT OUTSIDE OF THE MICROCATHETER TIP. DESPITE MULTIPLE ATTEMPTS, THE LEAVES ON THE LEFT KEPT EXTENDING INTO THE BASE OF THE ANEURYSM AND NOT FALL INTO THE LEFT POSTERIOR CEREBRAL ARTERY (PCA); THE PULSERIDER Y DEVICE WAS REMOVED. THE PROWLER SELECT PLUS MICROCATHETER WAS THEN ADVANCED OVER THE WIRE INTO THE BASE OF THE ANEURYSM AND THE PULSERIDER T, 4MM, 8MM ARCH (203D / W3262-02) WAS INTRODUCED THROUGH THE MICROCATHETER. THE DISTAL MARKERS WERE SEEN OPENING AT THE BASE WITHIN THE ANEURYSM. THE LEAVES ON THE DEVICE WERE SEEN FOLLOWING NICELY INTO THE RESPECTIVE POSTERIOR CEREBRAL ARTERIES. THE DEVICE WAS THEN GENTLY ADVANCED TO BRING THE DISTAL MARKERS FLUSH AGAINST THE UPPER WALLS OF THE VESSELS. THE MICROCATHETER WAS WITHDRAWN TO UNSHEATHE AND DEPLOY THE STEM OF THE PULSERIDER T DEVICE, WHICH WAS SEEN OPPOSING THE WALLS OF THE VESSEL VERY WELL. THERE WAS A NORMAL APPEARANCE OF THE DISTAL LEFT VERTEBRAL ARTERY, BASILAR TRUNK AND BILATERAL POSTERIOR CEREBRAL ARTERIES WITHOUT EVIDENCE OF FLOW LIMITATION. A 4MM X 7CM, 3MM X 6MM, 2.5MM X 5CM, 2.5MM X 2.5CM GALAXY G3 AND A 1.5MM X 3CM TARGET 360 NANO COIL WERE DELIVERED WITHIN THE DOME OF THE ANEURYSM AND DETACHED. FOLLOWING DEPLOYMENT OF THE COILS, THE COILING MICROCATHETER WAS REMOVED. THE PROWLER SELECT PLUS MICROCATHETER WAS GENTLY ADVANCED JUST BEYOND THE DISTAL MARKERS WHILE STABILIZING THE DELIVERY WIRE OF THE PULSERIDER. THE PULSERIDER WAS THEN DETACHED. THE PROWLER SELECT PLUS CATHETER WAS THEN REMOVED AFTER CONFIRMING DETACHMENT. THERE WAS NO APPARENT RESIDUAL ANEURYSM. ON A CLOSER REVIEW, A FOCAL IRREGULARITY WAS NOTED NEAR THE SUPERIOR ASPECT OF THE ORIGIN OF THE RIGHT SUPERIOR CEREBELLAR ARTERY (SCA). ANGIOGRAM WAS REPEATED IN THE STANDARD ANTERIOR-POSTERIOR (AP) AND LATERAL PROJECTIONS; THE ANGIOGRAM CLEARLY DEMONSTRATES A SMALL PSEUDOANEURYSM WITH A SECONDARY POUCH FROM THE ORIGIN OF THE RIGHT SUPERIOR CEREBELLAR ARTERY. NO ACTIVE EXTRAVASATION WAS NOTED. THE PATIENT WASH HEMODYNAMICALLY STABLE. A 3-D ROTATIONAL ANGIOGRAM WAS THEN PERFORMED TO DELINEATE THE POINT OF DISSECTION. UPON FURTHER REVIEW, AN APPROXIMATE 8MM IRREGULAR SHAPED PSEUROANEURYSMAL POUCH WAS NOTED LATERAL AND ANTERIOR TO THE DISTAL BASILAR TRUNK ACROSS THE RIGHT SCA. THE NECK OF THE ANEURYSM APPEARED TO BE FROM THE BASILAR-RIGHT SCA JUNCTION. THE PROWLER SELECT LP MICROCATHETER WAS THEN QUICKLY RE-INTRODUCED OVER WIRE THROUGH THE GUIDE CATHETER INTO THE BASILAR TRUNK AND SUBSEQUENTLY JUST PROXIMAL TO THE ORIGIN OF THE RIGHT SCA. THE WIRE WAS GENTLY ADVANCED INTO THE PSEUDOANEURYSM, BUT PRESUMABLY DUE TO THE NARROW NECK, ANGULATION, AND LACK OF SUFFICIENT PURCHASE OF THE WIRE, THE MICROCATHETER COULD NOT BE ADVANCED INTO THE PSEUDOANEURYSM. AS A RESULT, IT WAS DECIDED NOT TO ATTEMPT TO PERFORM COIL EMBOLIZATION ON THE PSEUDOANEURYSM. A MARKSMAN MICROCATHETER WAS ADVANCED OVER THE WIRE INTO THE MID RIGHT SCA. THE WIRE WAS REMOVED, AND AN EXCHANGE LENGTH SYNCHRO STANDARD WIRE WAS ADVANCED THROUGH THE MICROCATHETER INTO THE DISTAL RIGHT SCA. THE PROWLER MICROCATHETER WAS THEN EXCHANGED FOR A MARKSMAN MICROCATHETER. A 4.5MM X 15MM NEUROFORM EZ 3 STENT WAS DEPLOYED FROM THE PROXIMAL RIGHT SCA THROUGH THE MID BASILAR ARTERY. THE STENT WAS WELL APPOSED AGAINST THE VESSEL WALLS. THERE WAS NO CONTRAST EXTRAVASATION OR PSEUDOANEURYSM OPACIFICATION. IMMEDIATELY POST PROCEDURE, THE PATIENT WAS NOTED TO BE NOT RECOVERING FROM GENERAL ANESTHESIA. A STAT COMPUTED TOMOGRAPHY (CT) WAS OBTAINED WHICH DEMONSTRATED MASSIVE SUBARACHNOID HEMORRHAGE INVOLVING THE BASAL, SUPRASELLAR AND SYLVIAN CISTERNS, ALONG WITH SIGNIFICANT HYDROCEPHALUS. AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS IMMEDIATELY PLACED AND HEPARIN WAS REVERSED WITH PROTAMINE. THE PATIENT WAS TRANSFERRED TO THE ICU AND REMAINS COMATOSE, INTUBATED AND UNRESPONSIVE TO VERBAL STIMULI. SHE WITHDRAWS FROM NOXIOUS STIMULI AND HAS A POSITIVE COUGH, GAG AND CORNEAL REFLEXES. PSEUDOANEURYSM, HEMORRHAGE AND NEUROLOGICAL SEQUELAE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH THE PULSERIDER DEVICE. BASED ON REVIEW OF THE PROCEDURE REPORT AND INFORMATION PROVIDED BY THE PHYSICIAN, IT APPEARS THAT THE HEMORRHAGE WAS THE RESULT OF A PSEUDOANEURYSM THAT FORMED DURING THE PROCEDURE. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE PSEUDOANEURYSM OR SUBSEQUENT HEMORRHAGE; HOWEVER, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AS OF (B)(6) 2018, IT WAS REPORTED THAT THE PATIENT HAD NOT REGAINED CONSCIOUSNESS AND WAS WITH MINIMAL IMPROVEMENT IN CONDITION. THE PHYSICIAN BELIEVES THAT THE ARCH OF THE PULSERIDER DEVICE MAY HAVE PERFORATED THE RIGHT SCA. THE PHYSICIAN COMMENTED THAT HEMORRHAGE WAS A RISK OF SURGERY BUT WAS NOT SURE WHAT HAD HAPPENED. IT WAS REPORTED THAT THE GALAXY G3 COILS WERE MAINTAINED WITHIN THE ANEURYSM AND THE ANEURYSM HAD NOT RUPTURED. THE PULSERIDER Y WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (W2618-07) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. THE INFORMATION RELATED TO THE MALFUNCTION OF THE PULSERIDER Y DEVICE HAVING DIFFICULTY WITH PLACEMENT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE REPORTED DEVICE MALFUNCTION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE AND/OR DEVICE MANIPULATION/INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008680601-2018-00556 AND 3008680601-2018-00557. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE HEALTHCARE PROFESSIONAL REPORTED THAT A (B)(6) FEMALE PATIENT PRESENTED WITH AN ANEURYSM FROM THE TOP OF THE BASILAR ARTERY ON NEUROIMAGING STUDIES THAT WAS DONE IN WORK UP AFTER EXPERIENCING A 3-DAY HISTORY OF CONFUSION IN (B)(6) 2018. THE PATIENT UNDERWENT SELECTIVE ANGIOGRAPHY ON (B)(6) 2018, THAT DEMONSTRATED A SMALL, BROAD-BASED ANEURYSM MEASURING 1.8MM X 3.5MM FROM THE TOP OF THE BASILAR ARTERY, PROJECTING SUPERIORLY AND SLIGHTLY TO THE LEFT. THE BASE OF THE ANEURYSM WAS OFFSET TO THE LEFT TO MORE INVOLVE THE COMMON ORIGIN OF THE LEFT POSTERIOR CEREBRAL SUPERIOR CEREBELLAR ARTERIES. A MILD FOCAL NARROWING WAS NOTED AT THE DISTAL BASILAR ARTERY. ELECTIVE TREATMENT WAS RECOMMENDED GIVEN THE SIZE AND LOCATION OF THE ANEURYSM. THE PATIENTLY REPORTEDLY DECLINED NEUROSURGICAL REFERRAL FOR CLIP LIGATION CONSIDERATION; ENDOVASCULAR APPROACH WITH RECONSTRUCTION OF THE ANEURYSM NECK WAS OFFERED USING EITHER THE NEUROFORM STENT OR THE PULSERIDER DEVICES WAS OFFERED. WITH THE LESION LOCATION AT THE DISTAL BASILAR ARTERY, THE PULSERIDER DEVICE WAS CHOSEN. THE PATIENT WAS STARTED ON DUAL ANTIPLATELET THERAPY PRIOR TO THE PULSERIDER PROCEDURE. THE PULSERIDER PROCEDURE TOOK PLACE ON (B)(6) 2018, THE PHYSICIAN SELECTED THE PULSERIDER Y, 4MM, 8MM ARCH (303D / W2618-07). THE PULSERIDER Y DEVICE WAS ADVANCED THROUGH THE PROWLER SELECT PLUS (606S255X). THE DEVICE WAS ADVANCED GENTLY BEYOND THE MICROCATHETER TIP FRONTAL AND THE 4 DISTAL MARKERS WERE SEEN FLOWERED OUT OUTSIDE OF THE MICROCATHETER TIP. DESPITE MULTIPLE ATTEMPTS, THE LEAVES ON THE LEFT KEPT EXTENDING INTO THE BASE OF THE ANEURYSM AND NOT FALL INTO THE LEFT POSTERIOR CEREBRAL ARTERY (PCA); THE PULSERIDER Y DEVICE WAS REMOVED. THE PROWLER SELECT PLUS MICROCATHETER WAS THEN ADVANCED OVER THE WIRE INTO THE BASE OF THE ANEURYSM AND THE PULSERIDER T, 4MM, 8MM ARCH (203D / W3262-02) WAS INTRODUCED THROUGH THE MICROCATHETER. THE DISTAL MARKERS WERE SEEN OPENING AT THE BASE WITHIN THE ANEURYSM. THE LEAVES ON THE DEVICE WERE SEEN FOLLOWING NICELY INTO THE RESPECTIVE POSTERIOR CEREBRAL ARTERIES. THE DEVICE WAS THEN GENTLY ADVANCED TO BRING THE DISTAL MARKERS FLUSH AGAINST THE UPPER WALLS OF THE VESSELS. THE MICROCATHETER WAS WITHDRAWN TO UNSHEATH AND DEPLOY THE STEM OF THE PULSERIDER T DEVICE, WHICH WAS SEEN OPPOSING THE WALLS OF THE VESSEL VERY WELL. THERE WAS A NORMAL APPEARANCE OF THE DISTAL LEFT VERTEBRAL ARTERY, BASILAR TRUNK AND BILATERAL POSTERIOR CEREBRAL ARTERIES WITHOUT EVIDENCE OF FLOW LIMITATION. A 4MM X 7CM, 3MM X 6MM, 2.5MM X 5CM, 2.5MM X 2.5CM GALAXY G3 AND A 1.5MM X 3CM TARGET 360 NANO COIL WERE DELIVERED WITHIN THE DOME OF THE ANEURYSM AND DETACHED. FOLLOWING DEPLOYMENT OF THE COILS, THE COILING MICROCATHETER WAS REMOVED. THE PROWLER SELECT PLUS MICROCATHETER WAS GENTLY ADVANCED JUST BEYOND THE DISTAL MARKERS WHILE STABILIZING THE DELIVERY WIRE OF THE PULSERIDER. THE PULSERIDER WAS THEN DETACHED. THE PROWLER SELECT PLUS CATHETER WAS THEN REMOVED AFTER CONFIRMING DETACHMENT. THERE WAS NO APPARENT RESIDUAL ANEURYSM. ON A CLOSER REVIEW, A FOCAL IRREGULARITY WAS NOTED NEAR THE SUPERIOR ASPECT OF THE ORIGIN OF THE RIGHT SUPERIOR CEREBELLAR ARTERY (SCA). ANGIOGRAM WAS REPEATED IN THE STANDARD ANTERIOR-POSTERIOR (AP) AND LATERAL PROJECTIONS; THE ANGIOGRAM CLEARLY DEMONSTRATES A SMALL PSEUDOANEURYSM WITH A SECONDARY POUCH FROM THE ORIGIN OF THE RIGHT SUPERIOR CEREBELLAR ARTERY. NO ACTIVE EXTRAVASATION WAS NOTED. THE PATIENT WASH HEMODYNAMICALLY STABLE. A 3-D ROTATIONAL ANGIOGRAM WAS THEN PERFORMED TO DELINEATE THE POINT OF DISSECTION. UPON FURTHER REVIEW, AN APPROXIMATE 8MM IRREGULAR SHAPED PSEUROANEURYSMAL POUCH WAS NOTED LATERAL AND ANTERIOR TO THE DISTAL BASILAR TRUNK ACROSS THE RIGHT SCA. THE NECK OF THE ANEURYSM APPEARED TO BE FROM THE BASILAR-RIGHT SCA JUNCTION. THE PROWLER SELECT LP MICROCATHETER WAS THEN QUICKLY RE-INTRODUCED OVER WIRE THROUGH THE GUIDE CATHETER INTO THE BASILAR TRUNK AND SUBSEQUENTLY JUST PROXIMAL TO THE ORIGIN OF THE RIGHT SCA. THE WIRE WAS GENTLY ADVANCED INTO THE PSEUDOANEURYSM, BUT PRESUMABLY DUE TO THE NARROW NECK, ANGULATION, AND LACK OF SUFFICIENT PURCHASE OF THE WIRE, THE MICROCATHETER COULD NOT BE ADVANCED INTO THE PSEUDOANEURYSM. AS A RESULT, IT WAS DECIDED NOT TO ATTEMPT TO PERFORM COIL EMBOLIZATION ON THE PSEUDOANEURYSM. A MARKSMAN MICROCATHETER WAS ADVANCED OVER THE WIRE INTO THE MID RIGHT SCA. THE WIRE WAS REMOVED, AND AN EXCHANGE LENGTH SYNCHRO STANDARD WIRE WAS ADVANCED THROUGH THE MICROCATHETER INTO THE DISTAL RIGHT SCA. THE PROWLER MICROCATHETER WAS THEN EXCHANGED FOR A MARKSMAN MICROCATHETER. A 4.5MM X 15MM NEUROFORM EZ 3 STENT WAS DEPLOYED FROM THE PROXIMAL RIGHT SCA THROUGH THE MID BASILAR ARTERY. THE STENT WAS WELL APPOSED AGAINST THE VESSEL WALLS. THERE WAS NO CONTRAST EXTRAVASATION OR PSEUDOANEURYSM OPACIFICATION. IMMEDIATELY POST PROCEDURE, THE PATIENT WAS NOTED TO BE NOT RECOVERING FROM GENERAL ANESTHESIA. A STAT COMPUTED TOMOGRAPHY (CT) WAS OBTAINED WHICH DEMONSTRATED MASSIVE SUBARACHNOID HEMORRHAGE INVOLVING THE BASAL, SUPRASELLAR AND SYLVIAN CISTERNS, ALONG WITH SIGNIFICANT HYDROCEPHALUS. AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS IMMEDIATELY PLACED AND HEPARIN WAS REVERSED WITH PROTAMINE. THE PATIENT WAS TRANSFERRED TO THE ICU AND REMAINS COMATOSE, INTUBATED AND UNRESPONSIVE TO VERBAL STIMULI. SHE WITHDRAWS FROM NOXIOUS STIMULI AND HAS A POSITIVE COUGH, GAG AND CORNEAL REFLEXES. PSEUDOANEURYSM, HEMORRHAGE AND NEUROLOGICAL SEQUELAE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH THE PULSERIDER DEVICE. BASED ON REVIEW OF THE PROCEDURE REPORT AND INFORMATION PROVIDED BY THE PHYSICIAN, IT APPEARS THAT THE HEMORRHAGE WAS THE RESULT OF A PSEUDOANEURYSM THAT FORMED DURING THE PROCEDURE. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE PSEUDOANEURYSM OR SUBSEQUENT HEMORRHAGE; HOWEVER, PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AS OF (B)(6) 2018, IT WAS REPORTED THAT THE PATIENT HAD NOT REGAINED CONSCIOUSNESS AND WAS WITH MINIMAL IMPROVEMENT IN CONDITION. THE PHYSICIAN BELIEVES THAT THE ARCH OF THE PULSERIDER DEVICE MAY HAVE PERFORATED THE RIGHT SCA. THE PHYSICIAN COMMENTED THAT HEMORRHAGE WAS A RISK OF SURGERY BUT WAS NOT SURE WHAT HAD HAPPENED. IT WAS REPORTED THAT THE GALAXY G3 COILS WERE MAINTAINED WITHIN THE ANEURYSM AND THE ANEURYSM HAD NOT RUPTURED. THE PULSERIDER Y WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791185 | PULSERIDER Y, 4MM, 8MM ARCH | INTRACRANIAL NEUROVASCULAR STENT | NJE | PULSAR VASCULAR | W2618-07 | 00859030005109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Life Threatening| R |