GATEWAY®
Report
- Report Number
- 2939204-2011-00408
- Event Type
- Death
- Date Received
- August 15, 2011
- Date of Event
- June 26, 2011
- Report Date
- August 6, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- GBA
- PMA / PMN Number
- H050001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDITIONAL CLARIFICATION WAS RECEIVED FROM THE USER FACILITY. THE PATIENT PRESENTED TO THE FACILITY WITH A NATIONAL INSTITUTE OF HEALTH SCIENCES STROKE SCORE OF 19. A HEAD CT ANGIOGRAM DEMONSTRATED A LEFT MIDDLE CEREBRAL ARTERY OCCLUSION AND CT PERFUSION DEMONSTRATED A LARGE LEFT HEMISPHERIC PERFUSION DEFICIT; SUGGESTIVE OF A VERY LARGE STROKE IN EVOLUTION. THE PATIENT HAD A POOR PROGNOSIS AND THE DEVICE WAS USED IN AN ATTEMPT TO TRY AND SAVE THE PATIENT. THE PATIENT OUTCOME OF DEATH WAS RELATED TO MANY FACTORS, AND PROCEDURAL FACTORS CANNOT BE EXCLUDED BUT FIRST AND FOREMOST THE OUTCOME WAS RELATED TO THE SEVERITY OF THE PRESENTING STROKE AND MCA OCCLUSION.
CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. A SHIP HISTORY REVIEW IDENTIFIED THREE LOTS SUPPLIED TO THE CUSTOMER PRIOR TO THE REPORTED EVENT. A DEVICE HISTORY RECORD REVIEW OF THE THREE LOTS CONFIRMED THAT THEY ALL MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE LABELING FOUND THAT THE DEVICE HAD BEEN USED OFF LABEL, AS NOTED BY THE USER FACILITY, TO TREAT THE OCCLUDED VESSEL. HOWEVER, IT COULD NOT BE DETERMINED IF THE REPORTED EVENT OF HEMORRHAGE WAS ATTRIBUTABLE TO THE OFF LABEL USE AS THE DIRECTIONS FOR USE (DFU) LIST THIS AS AN ANTICIPATED COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE. AS IT CANNOT BE DETERMINED THAT THE OFF LABEL USE OF THE DEVICE WAS THE CAUSE OF THE EVENT AND THE REPORT PATIENT EFFECT IS NOTED IN THE DFU, IT WAS CONCLUDED THAT THIS EVENT WAS MOST LIKELY AN ANTICIPATED PROCEDURAL COMPLICATION.
THE PATIENT PRESENTED WITH A STROKE DUE TO AN OCCLUDED LEFT MIDDLE CEREBRAL ARTERY (MCA). SIX AND HALF HOURS POST SYMPTOM ONSET, A THROMBECTOMY WAS PERFORMED WITH CONSTANT MANUAL SUCTION FROM THE GUIDE CATHETER. ANGIOGRAPHY DEMONSTRATED PERSISTENCE OF THE LARGE OCCLUSION WITH A LARGE PARENCHYMAL DEFECT. A STENT WAS SUCCESSFULLY DEPLOYED BETWEEN "LEFT MCA AND MAIN BRANCH" AND 8MG OF TISSUE PLASMINOGEN ACTIVATOR AND 5MG OF REOPRO WERE INFUSED. ANGIOGRAPHY DEMONSTRATED THROMBOSIS IN MYOCARDIAL INFARCTION SCORE OF 1 WITH FLOW ACROSS THE MCA AND MAIN BRANCH WITH VERY SLOW PARENCHYMAL PHASE IN THE LEFT TEMPOROPARIETAL CORTEX. THERE WAS SIGNIFICANT STENOSIS OF THE STENT WITH ALMOST COMPLETE OCCLUSION SO ANGIOPLASTY WAS PERFORMED WITHIN THE STENTED REGION. POST ANGIOPLASTY ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION ALONG THE TRAJECTORY OF THE LEFT MCA. 20MG OF PROTAMINE WAS INFUSED INTRAVENOUSLY AND THE PROCEDURE TERMINATED. A CT SCAN REVEALED A BRAIN HEMORRHAGE. FOLLOWING CONSULTATION, THE FAMILY DECIDED TO PLACE THE PATIENT ON COMFORT CARE ONLY. THE PATIENT DIED TWO DAYS POST PROCEDURE, THE CAUSE WAS UNSPECIFIED CEREBRAL ARTERY OCCLUSION WITH CEREBRAL INFARCTION
THE PATIENT PRESENTED WITH A STROKE DUE TO AN OCCLUDED LEFT MIDDLE CEREBRAL ARTERY (MCA). SIX AND HALF HOURS POST SYMPTOM ONSET, A THROMBECTOMY WAS PERFORMED WITH CONSTANT MANUAL SUCTION FROM THE GUIDE CATHETER. ANGIOGRAPHY DEMONSTRATED PERSISTENCE OF THE LARGE OCCLUSION WITH A LARGE PARENCHYMAL DEFECT. A STENT WAS SUCCESSFULLY DEPLOYED BETWEEN "LEFT MCA AND MAIN BRANCH" AND 8MG OF TISSUE PLASMINOGEN ACTIVATOR AND 5MG OF REOPRO WERE INFUSED. ANGIOGRAPHY DEMONSTRATED THROMBOSIS IN MYOCARDIAL INFARCTION SCORE OF 1 WITH FLOW ACROSS THE MCA AND MAIN BRANCH WITH VERY SLOW PARENCHYMAL PHASE IN THE LEFT TEMPOROPARIETAL CORTEX. THERE WAS SIGNIFICANT STENOSIS OF THE STENT WITH ALMOST COMPLETE OCCLUSION SO ANGIOPLASTY WAS PERFORMED WITHIN THE STENTED REGION. POST ANGIOPLASTY ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION ALONG THE TRAJECTORY OF THE LEFT MCA. 20MG OF PROTAMINE WAS INFUSED INTRAVENOUSLY AND THE PROCEDURE TERMINATED. A CT SCAN REVEALED A BRAIN HEMORRHAGE. FOLLOWING CONSULTATION, THE FAMILY DECIDED TO PLACE THE PATIENT ON COMFORT CARE ONLY. THE PATIENT DIED TWO DAYS POST PROCEDURE, THE CAUSE WAS UNSPECIFIED CEREBRAL ARTERY OCCLUSION WITH CEREBRAL INFARCTION.
THE PATIENT PRESENTED WITH A STROKE DUE TO AN OCCLUDED LEFT MIDDLE CEREBRAL ARTERY (MCA). SIX AND HALF HOURS POST SYMPTOM ONSET, A THROMBECTOMY WAS PERFORMED WITH CONSTANT MANUAL SUCTION FROM THE GUIDE CATHETER. ANGIOGRAPHY DEMONSTRATED PERSISTENCE OF THE LARGE OCCLUSION WITH A LARGE PARENCHYMAL DEFECT. A STENT WAS SUCCESSFULLY DEPLOYED BETWEEN "LEFT MCA AND MAIN BRANCH" AND 8MG OF TISSUE PLASMINOGEN ACTIVATOR AND 5MG OF REOPRO WERE INFUSED. ANGIOGRAPHY DEMONSTRATED THROMBOSIS IN MYOCARDIAL INFARCTION SCORE OF 1 WITH FLOW ACROSS THE MCA AND MAIN BRANCH WITH VERY SLOW PARENCHYMAL PHASE IN THE LEFT TEMPOROPARIETAL CORTEX. THERE WAS SIGNIFICANT STENOSIS OF THE STENT WITH ALMOST COMPLETE OCCLUSION SO ANGIOPLASTY WAS PERFORMED WITHIN THE STENTED REGION. POST ANGIOPLASTY ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION ALONG THE TRAJECTORY OF THE LEFT MCA. TWENTY MG OF PROTAMINE WAS INFUSED INTRAVENOUSLY AND THE PROCEDURE TERMINATED. A CT SCAN REVEALED A BRAIN HEMORRHAGE. FOLLOWING CONSULTATION, THE FAMILY DECIDED TO PLACE THE PATIENT ON COMFORT CARE ONLY. THE PATIENT DIED TWO DAYS POST PROCEDURE, THE CAUSE WAS UNSPECIFIED CEREBRAL ARTERY OCCLUSION WITH CEREBRAL INFARCTION AND WAS MOST PROBABLY RELATED TO THE PRESENTING CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GATEWAY® | CATHETER, BALLOON TYPE | GBA | BOSTON SCIENTIFIC - MAPLE GROVE | M0032072215200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death| R | WINGSPAN STENT (BOSTON SCIENTIFIC)| FIRM RETRIEVER (CONCENTRIC) |