NEUROFORM 3 EZ 2.5 X 15MM
Report
- Report Number
- 3008881809-2016-00150
- Event Type
- Death
- Date Received
- August 26, 2016
- Date of Event
- March 21, 2016
- Report Date
- July 27, 2016
- Manufacturer
- STRYKER NEUROVASCULAR CORK
- Product Code
- NJE
- PMA / PMN Number
- H020002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
EXECUTIVE SUMMARY : CORRECTED. CONCOMITANT PRODUCTS - UPDATED. CHANGE PATIENT CODES: CORRECTED. THIS IS 1 OF 5 REPORT FILED FOR THIS EVENT.
THE SUBJECT DEVICE IS NOT AVAILABLE.
EVENT DATE - CORRECTED. CONCOMITANT PRODUCTS - CORRECTED. THIS IS 1 OF 5 REPORTS FILED FOR THIS EVENT.
EXECUTIVE SUMMARY: UPDATED REFLECTING ANEURYSM PERFORATION BY THE THIRD COIL USED DURING PROCEDURE. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, HEMORRHAGE, STROKE, HEMATOMA, NEUROLOGICAL/INTRACRANIAL SEQUELAE AND PATIENT OUTCOME OF DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT. THIS IS REPORT 1 OF 6 FILED ASSOCIATED FOR THIS EVENT: 3008881809-2016-00159 (TARGET); 3008881809-2016-00160 (TARGET); 3008881809-2016-00161 (TARGET); 3008881809-2016-00162 (TARGET); 3008881809-2016-00262 (TARGET ¿ ANEURYSM PERFORATION).
THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE ANALYSIS CANNOT BE PERFORMED. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, PATIENT HEMORRHAGE/BLOOD LOSS WITH SEQUELAE, STROKE, HEMATOMA, NEUROLOGICAL SEQUELAE AND DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES, AND ARE LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT.
THE PATIENT UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLICATED BY ANEURYSM PERFORATION, INCREASED SUBARACHNOID HEMORRHAGE AND WORSENING HYDROCEPHALUS. THE PERFORATION WAS TREATED WITH FURTHER COIL PLACEMENT AND THE PATIENT RECEIVED 10 MG REOPRO (ABCIXIMAB) DURING THE PROCEDURE AFTER THE STENT PLACEMENT TO PREVENT ACUTE STENT THROMBOSIS. DUE TO THE ANEURYSM PERFORATION EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED 3 HOURS AFTER THE ANEURYSM COILING. THE PATIENT WAS STARTED WITH PLAVIX (CLOPIDOGREL) AND ASPIRIN (DOSES UNKNOWN). FOLLOW UP MRI AND MRA ON THE SECOND DAY POST PROCEDURE SHOWED COMPLETE OCCLUSION OF THE ANEURYSM AND ALL SURROUNDING ARTERIES WERE PATENT. ACUTE CORTICAL INFARCTS IN BOTH ANTERIOR CEREBRAL AND MIDDLE CEREBRAL ARTERIES WERE OBSERVED BUT NO NEW HEMORRHAGE. THE PATIENT WAS FOUND TO HAVE LEFT SIDE WEAKNESS ON THE THIRD DAY POST PROCEDURE, AND THE EVD WAS FOUND NO LONGER DRAINING. A CT SCAN SHOWED A HEMATOMA IN RIGHT FRONTAL LOBE. PLAVIX AND ASPIRIN WERE HELD, AND AN INTRA-CATHETER TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADDED TO THE TREATMENT. ON THE FIFTH DAY, THE PATIENT DETERIORATED AND UNDERWENT URGENT SURGICAL DECOMPRESSIVE CRANIECTOMY TO DECOMPRESS AN EXPANSION OF THE RIGHT FRONTAL HEMATOMA. CTA SCAN AT THAT TIME SHOWED PATENCY OF THE STENT, ANTERIOR CEREBRAL (ACA) AND A-COM ARTERIES. THE PATIENT CONDITION PROGRESSIVELY WORSENED DESPITE MAXIMUM MEDICAL THERAPY. THE PATIENT WAS PRONOUNCED BRAIN DEAD APPROXIMATELY 10 DAYS POST THE INITIAL PROCEDURE. THE USER FACILITY INDICATED THAT WHILE THE PATIENT'S DEATH WAS NOT DIRECTLY RELATED TO THE STENT, THE USE OF ANTIPLATELET AGENTS ASSOCIATED WITH THE STENT MAY HAVE PREDISPOSED TO THE SUBSEQUENT CEREBRAL HEMORRHAGES.
THE PATIENT UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM). IT WAS REPORTED THAT THE PROCEDURE WAS COMPLICATED BY ANEURYSM PERFORATION, INCREASED SUBARACHNOID HEMORRHAGE AND WORSENING HYDROCEPHALUS. DUE TO THE ANEURYSM PERFORATION EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED 3 HOURS AFTER THE ANEURYSM COILING. THE PATIENT WAS STARTED WITH PLAVIX (CLOPIDOGREL) AND ASPIRIN (DOSES UNKNOWN). FOLLOW UP MRI AND MRA ON THE SECOND DAY POST PROCEDURE SHOWED COMPLETE OCCLUSION OF THE ANEURYSM AND ALL SURROUNDING ARTERIES WERE PATENT. ACUTE CORTICAL INFARCTS IN BOTH ANTERIOR CEREBRAL AND MIDDLE CEREBRAL ARTERIES WERE OBSERVED BUT NO NEW HEMORRHAGE. THE PATIENT WAS FOUND TO HAVE LEFT SIDE WEAKNESS ON THE THIRD DAY POST PROCEDURE, AND THE EVD WAS FOUND NO LONGER DRAINING. A CT SCAN SHOWED A HEMATOMA IN RIGHT FRONTAL LOBE. PLAVIX AND ASPIRIN WERE HELD, AND AN INTRA-CATHETER TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADDED TO THE TREATMENT. ON THE FIFTH DAY, THE PATIENT DETERIORATED AND UNDERWENT URGENT SURGICAL DECOMPRESSIVE CRANIECTOMY TO DECOMPRESS AN EXPANSION OF THE RIGHT FRONTAL HEMATOMA. CTA SCAN AT THAT TIME SHOWED PATENCY OF THE STENT, ANTERIOR CEREBRAL (ACA) AND A-COM ARTERIES. THE PATIENT CONDITION PROGRESSIVELY WORSENED DESPITE MAXIMUM MEDICAL THERAPY. THE PATIENT WAS PRONOUNCED BRAIN DEAD APPROXIMATELY 10 DAYS POST THE INITIAL PROCEDURE. THE USER FACILITY INDICATED THAT WHILE THE PATIENT'S DEATH WAS NOT DIRECTLY RELATED TO THE STENT, THE USE OF ANTIPLATELET AGENTS ASSOCIATED WITH THE STENT MAY HAVE PREDISPOSED TO THE SUBSEQUENT CEREBRAL HEMORRHAGES.
THE PATIENT UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM). IT WAS REPORTED THAT THE PROCEDURE WAS COMPLICATED BY ANEURYSM PERFORATION, INCREASED SUBARACHNOID HEMORRHAGE AND WORSENING HYDROCEPHALUS. DUE TO THE ANEURYSM PERFORATION EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED 3 HOURS AFTER THE ANEURYSM COILING. THE PATIENT WAS STARTED WITH PLAVIX (CLOPIDOGREL) AND ASPIRIN (DOSES UNKNOWN). FOLLOW UP MRI AND MRA ON THE SECOND DAY POST PROCEDURE SHOWED COMPLETE OCCLUSION OF THE ANEURYSM AND ALL SURROUNDING ARTERIES WERE PATENT. ACUTE CORTICAL INFARCTS IN BOTH ANTERIOR CEREBRAL AND MIDDLE CEREBRAL ARTERIES WERE OBSERVED BUT NO NEW HEMORRHAGE. THE PATIENT WAS FOUND TO HAVE LEFT SIDE WEAKNESS ON THE THIRD DAY POST PROCEDURE, AND THE EVD WAS FOUND NO LONGER DRAINING. A CT SCAN SHOWED A HEMATOMA IN RIGHT FRONTAL LOBE. PLAVIX AND ASPIRIN WERE HELD, AND AN INTRA-CATHETER TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADDED TO THE TREATMENT. ON THE FIFTH DAY, THE PATIENT DETERIORATED AND UNDERWENT URGENT SURGICAL DECOMPRESSIVE CRANIECTOMY TO DECOMPRESS AN EXPANSION OF THE RIGHT FRONTAL HEMATOMA. CTA SCAN AT THAT TIME SHOWED PATENCY OF THE STENT, ANTERIOR CEREBRAL (ACA) AND A-COM ARTERIES. THE PATIENT CONDITION PROGRESSIVELY WORSENED DESPITE MAXIMUM MEDICAL THERAPY. THE PATIENT WAS PRONOUNCED BRAIN DEAD APPROXIMATELY 10 DAYS POST THE INITIAL PROCEDURE. THE USER FACILITY INDICATED THAT WHILE THE PATIENT'S DEATH WAS NOT DIRECTLY RELATED TO THE STENT, THE USE OF ANTIPLATELET AGENTS ASSOCIATED WITH THE STENT MAY HAVE PREDISPOSED TO THE SUBSEQUENT CEREBRAL HEMORRHAGES.
THE PATIENT UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (A-COM) ANEURYSM. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLICATED BY ANEURYSM PERFORATION, INCREASED SUBARACHNOID HEMORRHAGE (SAH) AND WORSENING HYDROCEPHALUS. IT WAS REPORTED THAT PERFORATION OCCURRED AT THE END OF THE THIRD COIL PLACEMENT. THE PERFORATION WAS TREATED WITH FURTHER COILING AND 10 MG REOPRO (ABCIXIMAB) WERE ADMINISTERED ALONG WITH STENT PLACEMENT TO PREVENT ACUTE STENT THROMBOSIS. DUE TO THE ANEURYSM PERFORATION, EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED 3 HOURS AFTER THE ANEURYSM COILING. IN ADDITION, THE PATIENT WAS STARTED WITH PLAVIX (CLOPIDOGREL) AND ASPIRIN (DOSES UNKNOWN). NON-CONTRAST CT HEAD PERFORMED AFTER THE COILING, AND SMALL AMOUNT OF ADDITIONAL SAH WAS FOUND. PATIENT WAS ABLE TO FOLLOW COMMANDS, MOVE ALL EXTREMITIES THE NEXT DAY OF THE PROCEDURE. FOLLOW UP MRI AND MRA ON THE SECOND DAY POST PROCEDURE SHOWED COMPLETE OCCLUSION OF THE ANEURYSM AND ALL SURROUNDING ARTERIES WERE PATENT. ACUTE CORTICAL INFARCTS IN BOTH ANTERIOR CEREBRAL AND MIDDLE CEREBRAL ARTERIES WERE OBSERVED BUT NO NEW HEMORRHAGE. THE PATIENT WAS FOUND TO HAVE LEFT SIDE WEAKNESS ON THE THIRD DAY POST PROCEDURE, AND THE EVD WAS FOUND NO LONGER DRAINING. A CT SCAN SHOWED A HEMATOMA IN RIGHT FRONTAL LOBE. PLAVIX AND ASPIRIN WERE HELD, AND AN INTRA-CATHETER TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADDED TO THE TREATMENT. ON THE FIFTH DAY, THE PATIENT DETERIORATED AND UNDERWENT URGENT SURGICAL DECOMPRESSIVE CRANIECTOMY TO DECOMPRESS AN EXPANSION OF THE RIGHT FRONTAL HEMATOMA. CTA SCAN AT THAT TIME SHOWED PATENCY OF THE STENT, ANTERIOR CEREBRAL (ACA) AND A-COM ARTERIES. THE PATIENT CONDITION PROGRESSIVELY WORSENED DESPITE MAXIMUM MEDICAL THERAPY. THE PATIENT WAS PRONOUNCED BRAIN DEAD APPROXIMATELY 10 DAYS POST THE INITIAL PROCEDURE. THE USER FACILITY INDICATED WHILE THE SMALL LEAKAGE DURING ANEURYSM COILING AND THE STENT PLACEMENT WERE NOT DIRECTLY RELATED TO PATIENT'S DEATH, THE USE OF ANTIPLATELET AGENTS ASSOCIATED WITH THE STENT MAY HAVE PREDISPOSED TO THE SUBSEQUENT CEREBRAL HEMORRHAGES.
THE PATIENT UNDERWENT STENT ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLICATED BY ANEURYSM PERFORATION, INCREASED SUBARACHNOID HEMORRHAGE AND WORSENING HYDROCEPHALUS. THE PERFORATION WAS TREATED WITH FURTHER COIL PLACEMENT AND THE PATIENT RECEIVED 10 MG REOPRO (ABCIXIMAB) DURING THE PROCEDURE AFTER THE STENT PLACEMENT TO PREVENT ACUTE STENT THROMBOSIS. DUE TO THE ANEURYSM PERFORATION EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED 3 HOURS AFTER THE ANEURYSM COILING. THE PATIENT WAS STARTED WITH PLAVIX (CLOPIDOGREL) AND ASPIRIN (DOSES UNKNOWN). FOLLOW UP MRI AND MRA ON THE SECOND DAY POST PROCEDURE SHOWED COMPLETE OCCLUSION OF THE ANEURYSM AND ALL SURROUNDING ARTERIES WERE PATENT. ACUTE CORTICAL INFARCTS IN BOTH ANTERIOR CEREBRAL AND MIDDLE CEREBRAL ARTERIES WERE OBSERVED BUT NO NEW HEMORRHAGE. THE PATIENT WAS FOUND TO HAVE LEFT SIDE WEAKNESS ON THE THIRD DAY POST PROCEDURE, AND THE EVD WAS FOUND NO LONGER DRAINING. A CT SCAN SHOWED A HEMATOMA IN RIGHT FRONTAL LOBE. PLAVIX AND ASPIRIN WERE HELD, AND AN INTRA-CATHETER TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADDED TO THE TREATMENT. ON THE FIFTH DAY, THE PATIENT DETERIORATED AND UNDERWENT URGENT SURGICAL DECOMPRESSIVE CRANIECTOMY TO DECOMPRESS AN EXPANSION OF THE RIGHT FRONTAL HEMATOMA. CTA SCAN AT THAT TIME SHOWED PATENCY OF THE STENT, ANTERIOR CEREBRAL (ACA) AND A-COM ARTERIES. THE PATIENT CONDITION PROGRESSIVELY WORSENED DESPITE MAXIMUM MEDICAL THERAPY. THE PATIENT WAS PRONOUNCED BRAIN DEAD APPROXIMATELY 10 DAYS POST THE INITIAL PROCEDURE. THE USER FACILITY INDICATED THAT WHILE THE PATIENT¿S DEATH WAS NOT DIRECTLY RELATED TO THE STENT, THE USE OF ANTIPLATELET AGENTS ASSOCIATED WITH THE STENT MAY HAVE PREDISPOSED TO THE SUBSEQUENT CEREBRAL HEMORRHAGES..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557431 | NEUROFORM 3 EZ 2.5 X 15MM | STENT, INTRACRANIAL NEUROVASCULAR | NJE | STRYKER NEUROVASCULAR CORK | 17742908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Death| O| R |