PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2021-00775
- Event Type
- Death
- Date Received
- June 25, 2021
- Date of Event
- April 26, 2021
- Report Date
- April 9, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- PMA / PMN Number
- P100018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION RECEIVED REPORTED AN INCOMPLETE OCCLUSION, ADDITIONAL PLACEMENT WAS COMPLETED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DATA 36 MONTHS POST-PROCEDURE WAS UPDATED AND "MRS WORSENED (4 TO 6)" AND "OUTCOME: PATIENT DEATH" WAS CONFIRMED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE MRS 30 DAYS AFTER THE PROCEDURE WAS CHANGED FROM "4-MODERATE TO SEVERE IMPAIRMENT" TO " 3-MODERATE IMPAIRMENT". THE REASON FOR THE CHANGE WAS INCORRECT INPUT. THE MRS ON THE SAME DAY AS THE DAY OF DISCHARGE/ON THE 7TH DAY AFTER THE PROCEDURE WAS "3- MODERATE DISORDER" AND THE MRS ON THE 30TH DAY AFTER THE PROCEDURE WAS "3- MODERATE DISORDER", SO IT WAS DETERMINED THAT THE MRS DID NOT WORSEN. REGARDING THE REPEAT TREATMENT FOR INCOMPLETE OCCLUSION PERFORMED 6 MONTHS AFTER THE PROCEDURE ((B)(6) 2021), THE EVENT "INCOMPLETE OCCLUSION" WAS RECORDED AS AN ADVERSE EVENT (2) WITH THE FOLLOWING DETAILED INFORMATION. THERE WAS HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION. THERE WAS SURGICAL FLOW DIVIDER REPOSITIONING. CANNOT DENY CAUSAL RELATIONSHIP WITH DEVICE OR PROCEDURE. THE EVENT IS RECOVERING AS OF (B)(6) 2021.
PHYSICIAN INFORMATION IS NOT REPORTED DUE TO REGION PRIVACY LAWS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION REPORTING THAT A PATIENT WHO UNDERWENT A PROCEDURE FOR PIPELINE IMPLANTATION HAD POST-PROCEDURE COMPLICATIONS. THE PATIENT'S MRS PRE-PROCEDURE WAS 3. POST-PROCEDURE MRS WAS 4. IT WAS REPORTED THE PATIENT HAD TRUNK ATAXIA, FACIAL PARALYSIS, AND HEARING LOSS POST-PROCEDURE. THE ANEURYSM WAS DISCOVERED AFTER THE PATIENT EXPERIENCED CRANIAL NERVE DISORDER AND NEUROLOGICAL SYMPTOMS WITH NO PRIOR HISTORY. AN UNRUPTURED SPINDLE-SHAPED ANEURYSM OF THE LEFT VERTEBRAL ARTERY WITH A MAX DIAMETER OF 47.7MM WAS OBSERVED. THE PATIENT UNDERWENT A PROCEDURE FOR FLOW DIVERSION TREATMENT ON (B)(6) 2021 WITH A PIPELINE (MODEL: PED-500-35, LOT: B121666). NEUROLOGICAL SYMPTOMS WERE REPORTED TO OCCUR ON (B)(6) 2021. THERE WAS NO ALLEGATION OF ANY DEVICE MALFUNCTION OR DEFECT. MULTIPLE OTHER PIPELINES WERE INCLUDED IN THE REPORT INFORMATION WITHOUT ANY ALLEGATION; THERE WAS NO INFORMATION SUBMITTED IN THE INITIAL INFORMATION REGARDING THE OTHER PIPELINES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 968171 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-500-35 | B121666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Disability| D |