PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2022-01776
- Event Type
- Death
- Date Received
- October 24, 2022
- Date of Event
- September 27, 2022
- Report Date
- January 23, 2023
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00763000284145
- PMA / PMN Number
- P100018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
B5. UPDATED WITH ADDITIONAL INFORMATION RECEIVED. H6. EVAL CONCLUSION/FDC CODE UPDATED (D1001) BASED ON ADDITIONAL INFORMATION RECEIVED. ASSOCIATED WITH MDR #: 2029214-2022-01777. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH TWO PED2 PIPELINES HAD COMPLICATIONS AND DIED. WORSENED MASS EFFECT WITH 6 MM MIDLINE SHIFT ON RIGHT SIDE OF BRAIN. WORSENING OF HYDROCEPHALUS AND SUBARACHNOID HEMORRHAGE (SAH). EXTERNAL VENTRICULAR DRAIN PLACES (E.V.D) DUE TO ADVERSE EVENT (AE). WORSENING OF HYDROCEPHALUS AND SAH. "ECTERNAL" VENTRICULAR DRAIN PLACEMENT DUE TO AE. NEW FOCAL DISSECTION AND ASSOCIATE HIGH-GRADE STENOSIS INVOLVING THE DISTAL CERVICAL RIGHT INTERNAL CAROTID ARTERY JUST BEFORE IT ENTERS THE CAROTID CANAL. MODERATE VASOSPASM OF RIGHT ANTERIOR CIRCULATION AND MILD VASOSPASM OF LEFT ANTERIOR CIRCULATION AND LEFT POSTERIOR CEREBRAL ARTERY. THIS WAS TREATED WITH TRANSCATHETER INTRA-ARTERIAL INFUSION OF VERAPAMIL 20 MG TO RIGHT INTERNAL CAROTID ARTERY AND VERAPAMIL 10 MG TO THE LEFT INTERNAL CAROTID ARTERY (ICA). WORSENING OF LEFT-SIDED WEAKNESS PER PHYSICIAN. WORSENING OF LEFT-SIDED WEAKNESS PER NEUROLOGICAL CHECK BY PHYSICIAN. PATIENT WAS REINTUBATED DUE TO WORSENING OF RESPIRATORY DISTRESS. AS OF SEPT 28, 2022 CT THORAX SCAN: RIGHT UPPER, RIGHT LOWER AND LEFT LOWER LOBE AIRSPACE DISEASE. CONSOLIDATION LIKELY REPRESENTING COMBINATION OF PNEUMONIA AND ATELECTASIS. NEW FOCAL DISSECTION AND ASSOCIATE HIGH-GRADE STENOSIS INVOLVED DISTAL CERVICAL RIGHT ICA JUST BEFORE IT ENTERS CAROTID CANAL. DETECTED IN CTA NECK SCAN ON (B)(6) 2022 AT 11:00 AM CDT. BRAIN IMAGING ON (B)(6) 2022 INDICATED PATIENT WA S BRAIN DEAD. AFTER FURTHER INVESTIGATION BY NEURO TEAM, PATIENT'S DIAGNOSIS GOT WORSE WITH CEREBRAL EDEMA, STROKES, AND HERNIATION. INVESTIGATOR CONFIRMED PATIENT MET CLINICAL & RADIOGRAPHIC CRITERIA FOR BRAIN DEAD. INVESTIGATOR MENTIONED PATIENT'S CAUSE OF DEATH IS HERNIATION. ABSENT BLOOD FLOW, COMPATIBLE WITH BRAIN DEATH IN CLINICAL CONTEXT. DIFFUSE SCALP ACTIVITY VIA EXTERNAL CAROTID CIRCULATION. INCREASED ACTIVITY IN NOSE, INDICATIVE OF COLLATERAL FLOW THROUGH EXTERNAL CAROTID ARTERIES. SUPERIOR SAGITTAL SINUS IS NOT VISUALIZED. ABSENT BRAIN BLOOD FLOW, COMPATIBLE WITH BRAIN DEATH IN APPROPRIATE CLINICAL CONTEXT. NO ACTIVITY WITHIN CEREBRAL PARENCHYMA TO SUGGEST CEREBRAL PERFUSION. DIFFUSE SCALP ACTIVITY VIA EXTERNAL CAROTID CIRCULATION. THERE IS INCREASED ACTIVITY IN NOSE, INDICATIVE OF COLLATERAL FLOW THROUGH EXTERNAL CAROTID ARTERIES. SUPERIOR SAGITTAL SINUS IS NOT VISUALIZED. CEREBELLAR ACTIVITY IS NOT IDENTIFIED. DURING NEURO TEAM ROUNDING, IT WAS NOTED THAT PATIENT HAD TACHYCARDIA ON (B)(6) 2022. ON THE FOLLOW-UP CT ON (B)(6) 2022, IT SHOW A NEW LARGE RIGHT MIDDLE CEREBRAL ARTERY ISCHEMIC STROKE. THE ADVERSE EVENTS WERE RELATED IN THE CONTEXT OF SAH AND SEVERE VASOSPASM DUE TO RUPTURED BRAIN ANEURYSM. THE PATIENT WAS HOSPITALIZED WITH INTERVENTION REQUIRED. THE EVENTS WERE LIFE THREATENING AND CAUSED DISABILITY AND DEATH.
MEDTRONIC RECEIVED A REPORT THAT THE HEAD CT SCAN SHOWED A NEW LARGE RIGHT MIDDLE CEREBRAL ARTERY STROKE IN THE CONTEXT OF SUBARACHNOID HEMORRHAGE AND SEVERE VASOSPASM. THE PATIENT DEVELOPED LEFT SIDED HEMIPARESIS. THE PATIENT HAD INTRA-ATRIAL TREATMENT FOR VASOSPASM. SITE UPDATED LEFT SIDED WEAKNESS/HEMIPARESIS TO ACUTE ISCHEMIC STROKE DUE TO SD REPORT OF NEW LARGE RIGHT MIDDLE CEREBRAL ARTERY ISCHEMIC STROKE IN THE CONTEXT OF ANEURYSMAL SAH, RECALCITRANT VASOSPASM AND MALIGNANT CEREBRAL EDEMA.
ADDITIONAL INFORMATION RECEIVED REPORTED THE SITE ASSESSMENT OF THE EVENTS CONCLUDED THE EVENTS HAD A CAUSAL RELATIONSHIP TO THE PATIENT DISEASE UNDER STUDY AND WERE NOT RELATED TO THE PROCEDURE OR THE PIPELINE DEVICES.
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD SIGNS AND SYMPTOMS SUGGESTIVE OF MALIGNANT CEREBRAL EDEMA (MCE); RECALCITRANT HIGH INTRA CRANIAL PRESSURE (ICP) UP TO 30-70 DESPITE AGGRESSIVE MEASURES WITH MANNITOL, INCREASED SEDATION, ETC. WITH WORSENED NEURO EXAM. THE HEAD CT SCAN SHOWED WORSENED CEREBRAL EDEMA, COLLAPSED VENTRICLES AND DECREASED GRAY-WHITE DIFFERENTIATION. THIS APPEARED IN THE CONTEXT OF SUBARACHNOID HEMORRHAGE, WITH SEVERE VASOSPASM AND CEREBRAL EDEMA. THE MCE EVENTUALLY LED TO BRAIN HERNIATION/BRAIN DEATH AND PATIENT DEATH. ADDITIONAL MEDICAL INTERVENTION USED TO TRY AND PREVENT PERMANENT INJURY OR IMPAIRMENT WAS AGGRESSIVE MEASURES WITH MANNITOL, INCREASED SEDATION, AND EXTERNAL VENTRICULAR DRAIN TWO TIMES. THE SITE WAS QUERIED TO UPDATE THE ADVERSE EVENT "WORSENED MASS EFFECT" TO MALIGNANT CEREBRAL EDEMA (MCE) BECAUSE THE SIGNS AND SYMPTOMS FOUND IN THE TRANSMITTED SD ARE COMPATIBLE WITH THE DEFINITION OF MCE. SITE REPORTED MCE IN THE CONTEXT OF ANEURYSMAL SUBARACHNOID HEMORRHAGE (SAH), RECALCITRANT VASOSPASM AND LARGE RIGHT MIDDLE CEREBRAL ARTERY ISCHEMIC STROKE. MEDICAL HISTORY INCLUDED HYPERTENSION IN THE CONTEXT OF SUBARACHNOID HEMORRHAGE DUE TO RUPTURED BRAIN ANEURYSM.
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
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2495426 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-350-12 | B323216 | 00763000284145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Death |