PIPELINE
Report
- Report Number
- 2029214-2023-00291
- Event Type
- Death
- Date Received
- February 15, 2023
- Date of Event
- December 13, 2021
- Report Date
- February 15, 2023
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- PMA / PMN Number
- P100018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FLORES-MILAN G, PRESSMAN E, PETO I, REN Z, GUERRERO WR, MOKIN M. FACTORS ASSOCIATED WITH IN-STENT STENOSIS AFTER CEREBRAL ANEURYSM EMBOLIZATION USING A PIPELINE EMBOLIZATION DEVICE. INTERVENTIONAL NEURORADIOLOGY: JOURNAL OF PERITHERAPEUTIC NEURORADIOLOGY, SURGICAL PROCEDURES AND RELATED NEUROSCIENCES. 2022;28(6):731-736. DOI:10.1177/15910199211066368. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE 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.
FLORES-MILAN G, PRESSMAN E, PETO I, REN Z, GUERRERO WR, MOKIN M. FACTORS ASSOCIATED WITH IN-STENT STENOSIS AFTER CEREBRAL ANEURYSM EMBOLIZATION USING A PIPELINE EMBOLIZATION DEVICE. INTERVENTIONAL NEURORADIOLOGY: JOURNAL OF PERITHERAPEUTIC NEURORADIOLOGY, SURGICAL PROCEDURES AND RELATED NEUROSCIENCES. 2022;28(6):731-736. DOI:10.1177/15910199211066368. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THE PIPELINE EMBOLIZATION DEVICE. THE PURPOSE OF THIS ARTICLE WAS ANALYZE IN-STENT STENOSIS BY LOOKING AT INCIDENCE AND INTERVAL PROGRESSION OF THIS ANGIOGRAPHIC FINDING, ITS ASSOCIATED CLINICAL OUTCOMES, AND IDENTIFY POSSIBLE DEMOGRAPHIC, MORPHOLOGICAL, CLINICAL, OR PROCEDURAL ELEMENTS ASSOCIATED WITH IN-STENT STENOSIS. CONSECUTIVE CASES OF INTRACRANIAL ANEURYSMS (IAS) TREATED WITH PIPELINE EMBOLIZATION DEVICE (PED) BETWEEN SEPTEMBER 2014 AND DECEMBER 2018 WERE INCLUDED IN THIS STUDY IF THEY HAD AT LEAST DSA DURING FOLLOW-UP. ANEURYSM TREATMENT MODALITY WAS BASED ON OPERATOR PREFERENCE, CHOICE, AND NUMBER OF DEVICES. A TOTAL OF 94 PATIENTS HAD IA TREATED WITH PED. THE MEDIAN AGE WAS 59 YEARS, MEAN AGE WAS 61 YEARS. 76 OF 94 PATIENTS WERE FEMALES. PAST MEDICAL HISTORY INCLUDED HISTORY OF HYPERTENSION, DIABETES, DYSLIPIDEMIA, CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, SMOKING STATUS, PRIOR CEREBROVASCULAR ACCIDENT, AND CHRONIC KIDNEY DISEASE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE PED. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -AT THE TIME OF INITIAL DSA DURING FOLLOW-UP, IN-STENT STENOSIS WAS NOTED IN 52 PATIENTS AND MEASURED 17% ON AVERAGE. OF THE 52 PATIENTS WITH IN-STENT STENOSIS ON INITIAL DSA, 17 HAD A SECOND DSA DURING FOLLOW-UP. IN THIS 2ND DSA, IMPROVEMENT AND/OR STABLE IN-STENT STENOSIS WAS SEEN 16 PATIENTS. -ONE PATIENT OF THE 32 NOW HAD IN-STENT STENOSIS THAT WAS NOT PRESENT INITIALLY AND, IN THIS PATIENT, THE STENOTIC AREA CONTINUED TO WORSEN UNTIL THE STENT EVENTUALLY OCCLUDED BY AN UNCLEAR MECHANISM. THIS PATIENT ULTIMATELY SUCCUMBED FROM A STROKE SECONDARY TO THIS OCCLUSION 13 MONTHS AFTER DEVICE PLACEMENT. -ONE OTHER PATIENT WHO HAD A 2ND DSA WAS FOUND TO HAVE DEVELOPED MILD (~5%) IN-STENT STENOSIS THOUGH NO STENOSIS WAS SEEN IN THEIR 1ST DSA. SIXTY-THREE PATIENTS HAD AN MRA AT THE END OF FOLLOW-UP. 40 OF THESE PATIENTS INITIALLY HAD IN-STENT STENOSIS ¿ ALL HAD PATENCY OF THEIR STENT ON FOLLOW-UP MRA. OF THE 23 PATIENTS WITHOUT IN-STENT STENOSIS, 22 CONTINUED TO SHOW PATENCY (ONE PATIENT WITHOUT IN-STENT STENOSIS ORIGINALLY WAS FOUND TO HAVE AN ASYMPTOMATIC OCCLUSION OF THEIR FLOW DIVERTER STENT (FDS) DURING FOLLOW-UP) -THERE WAS COMPLETE ANEURYSM OCCLUSION IN 22 PATIENTS TREATED WITH PED + COILS AND IN 51 PATIENTS TREATED WITH PED ALONE. THE OVERALL RATE OF RESIDUAL ANEURYSM FILLING WAS 22.3% AT SIX MONTHS. OF THOSE WITH A SECOND FOLLOW-UP IMAGING MODALITY, CONSISTING OF DSA IN 32% AND MAGNETIC RESONANCE ANGIOGRAPHY (MRA) IN 68% OF CASES. ALL 21 PATIENTS WITH RESIDUAL ANEURYSM SEEN AT INITIAL FOLLOW-UP DSA HAD A SECOND DSA; ONLY 8 PATIENTS REMAINED WITH RESIDUAL ANEURYSM. AT THE END OF FOLLOW-UP, THE OVERALL ANEURYSM OCCLUSION RATE WAS 91.5%; THE 8 PATIENTS WERE RETREATED WITH A SECOND PED. -A TOTAL OF FIVE COMPLICATIONS OCCURRED WHICH CONSISTED OF TWO PATIENTS WITH TRANSIENT AMAUROSIS FUGAX, TWO WITH ASYMPTOMATIC FDS OCCLUSION, AND ONE WITH A CAVERNOUS FISTULA FORMATION AFTER FDS PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557489 | PIPELINE | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | NV UNK PIPELINE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Death| R |