PIPELINE
Report
- Report Number
- 2029214-2022-00215
- Event Type
- Death
- Date Received
- February 13, 2022
- Date of Event
- August 19, 2021
- Report Date
- February 13, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
LIANG, F., MA, C., ZHU, H., LIU, L., LIANG, S., JIANG, P., ZHANG, Y., & JIANG, C. (2021). USING ANGIOGRAPHIC PARAMETRIC IM AGING-DERIVED RADIOMICS FEATURES TO PREDICT COMPLICATIONS AND EMBOLIZATION OUTCOMES OF INTRACRANIAL ANEURYSMS TREATED BY PIPELINE EMBOLIZATION DEVICES. JOURNAL OF NEUROINTERVENTIONAL SURGERY. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2021-017832. AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
LIANG, F., MA, C., ZHU, H., LIU, L., LIANG, S., JIANG, P., ZHANG, Y., & JIANG, C. (2021). USING ANGIOGRAPHIC PARAMETRIC IM AGING-DERIVED RADIOMICS FEATURES TO PREDICT COMPLICATIONS AND EMBOLIZATION OUTCOMES OF INTRACRANIAL ANEURYSMS TREATED BY PIPELINE EMBOLIZATION DEVICES. JOURNAL OF NEUROINTERVENTIONAL SURGERY. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2021-017832. AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
LIANG, F., MA, C., ZHU, H., LIU, L., LIANG, S., JIANG, P., ZHANG, Y., <(>&<)>AMP; JIANG, C. (2021). USING ANGIOGRAPHIC PARAMETRIC IM AGING-DERIVED RADIOMICS FEATURES TO PREDICT COMPLICATIONS AND EMBOLIZATION OUTCOMES OF INTRACRANIAL ANEURYSMS TREATED BY PIPELINE EMBOLIZATION DEVICES. JOURNAL OF NEUROINTERVENTIONAL SURGERY. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2021-017832. SUMMARY: PIPELINE EMBOLIZATION DEVICES (PEDS) HAVE GAINED WIDESPREAD POPULARITY IN THE TREATMENT OF INTRACRANIAL ANEURYSMS (IAS). HOWEVER, PRECISE PREDICTORS OF TREATMENT OUTCOMES ARE STILL LACKING. THIS STUDY AIMED TO USE ANGIOGRAPHIC PARAMETRIC IMAGING (API)-DERIVED RADIOMICS FEATURES TO EXPLORE WHETHER BIOMARKERS EXTRACTED FROM IMMEDIATE POSTPROCEDURAL DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WERE ASSOCIATED WITH COMPLICATIONS AND EMBOLIZATION OUTCOMES OF IAS TREATED WITH PED WITHOUT ADJUNCTIVE COILS. IDENTIFIED EVENTS: THERE WERE 5 PATIENT DEATHS AS A RESULT OF EMBOLIZATION COMPLICATIONS. EVENT INFORMATION: THE MEAN MAXIMUM DIAMETER OF THE ANEURYSMS WAS 10.46±7.35MM. THE RATE OF ON-LABEL USE OF THE PED WAS 69.4%, INCLUDING 9.25% FOR CAVERNOUS CAROTID IAS, 55.16% FOR PARAOPHTHALMIC IAS, AND 4.98%14 FOR POSTERIOR COMMUNICATING ARTERY IAS. THE RATES OF OFF-LABEL USE OF THE PED WERE AS FOLLOWS: M1 AND M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY IAS, 1.78% AND 0.71%, RESPECTIVELY; VERTEBROBASILAR IAS, 27.76%; AND P2 SEGMENT IAS, 0.36%. THE MAJORITY OF THE PATIENTS HAD ONE PED; NINE PATIENTS HAD TWO PEDS AND ONE PATIENT HAD FOUR PEDS. SACCULAR ANEURYSMS 155 (55.16%) NON-SACCULAR ANEURYSMS 126 (44.84%).
LIANG, F., MA, C., ZHU, H., LIU, L., LIANG, S., JIANG, P., ZHANG, Y., <(>&<)>AMP; JIANG, C. (2021). USING ANGIOGRAPHIC PARAMETRIC IM AGING-DERIVED RADIOMICS FEATURES TO PREDICT COMPLICATIONS AND EMBOLIZATION OUTCOMES OF INTRACRANIAL ANEURYSMS TREATED BY PIPELINE EMBOLIZATION DEVICES. JOURNAL OF NEUROINTERVENTIONAL SURGERY. HTTPS://DOI.ORG/10.1136/NEURINTSURG-2021-017832. SUMMARY: PIPELINE EMBOLIZATION DEVICES (PEDS) HAVE GAINED WIDESPREAD POPULARITY IN THE TREATMENT OF INTRACRANIAL ANEURYSMS (IAS). HOWEVER, PRECISE PREDICTORS OF TREATMENT OUTCOMES ARE STILL LACKING. THIS STUDY AIMED TO USE ANGIOGRAPHIC PARAMETRIC IMAGING (API)-DERIVED RADIOMICS FEATURES TO EXPLORE WHETHER BIOMARKERS EXTRACTED FROM IMMEDIATE POSTPROCEDURAL DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WERE ASSOCIATED WITH COMPLICATIONS AND EMBOLIZATION OUTCOMES OF IAS TREATED WITH PED WITHOUT ADJUNCTIVE COILS. IDENTIFIED EVENTS: THERE WERE 5 PATIENT DEATHS AS A RESULT OF EMBOLIZATION COMPLICATIONS. EVENT INFORMATION: THE MEAN MAXIMUM DIAMETER OF THE ANEURYSMS WAS 10.46±7.35MM. THE RATE OF ON-LABEL USE OF THE PED WAS 69.4%, INCLUDING 9.25% FOR CAVERNOUS CAROTID IAS, 55.16% FOR PARAOPHTHALMIC IAS, AND 4.98%14 FOR POSTERIOR COMMUNICATING ARTERY IAS. THE RATES OF OFF-LABEL USE OF THE PED WERE AS FOLLOWS: M1 AND M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY IAS, 1.78% AND 0.71%, RESPECTIVELY; VERTEBROBASILAR IAS, 27.76%; AND P2 SEGMENT IAS, 0.36%. THE MAJORITY OF THE PATIENTS HAD ONE PED; NINE PATIENTS HAD TWO PEDS AND ONE PATIENT HAD FOUR PEDS. SACCULAR ANEURYSMS 155 (55.16%) NON-SACCULAR ANEURYSMS 126 (44.84%).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111384 | PIPELINE | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | NV UNK PIPELINE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | Death |