REACT CATHETER
Report
- Report Number
- 2029214-2024-00602
- Event Type
- Death
- Date Received
- April 9, 2024
- Date of Event
- May 2, 2023
- Report Date
- April 9, 2024
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- DQY
- PMA / PMN Number
- K180715
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID REACT-71 (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID REACT-68 (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID REACT-71 (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: NARLOCH J, PIASECKI A, ZIECINA P, D¸EBIEC A, WIERZBICKI M, STASZEWSKI J AND PIASECKI P. IS ASPIRATION AN EFFECTIVE ACUTE STROKE TREATMENT IN OLDER ADULTS?. FRONTIERS IN NEUROLOGY 2023. DOI: 10.3389/FNEUR.2023.114953 A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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.
NARLOCH J, PIASECKI A, ZIECINA P, DEBIEC A, WIERZBICKI M, STASZEWSKI J AND PIASECKI P (2023) IS ASPIRATION AN EFFECTIVE ACUTE STROKE TREATMENT IN OLDER ADULTS? FRONT. NEUROL. 14:1149531. DOI: 10.3389/FNEUR.2023.114953. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH REACT 68 AND 71 CATHETERS. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE THE CLINICAL AND ANGIOGRAPHIC OUTCOMES OF A DIRECT ASPIRATION FIRST-PASS TECHNIQUE IN INTERVENTIONAL STROKE TREATMENT FOR ELDERLY PATIENTS COMPARED WITH YOUNGER PATIENTS CONSECUTIVE PATIENTS WHO UNDERWENT ¿A DIRECT ASPIRATION FIRST-PASS TECHNIQUE¿ (ADAPT) AS THE FIRST CHOICE OF TREATMENT FOR THE TREATMENT OF STROKE DUE TO A LARGE VESSEL OCCLUSION BETWEEN JANUARY 2016 AND AUGUST 2021 AT A COMPREHENSIVE STROKE CENTER WERE INCLUDED IN THE PRESENT STUDY. A TOTAL OF 162 PATIENTS (92 WOMEN AND 70 MEN, AGED BETWEEN 35 AND 94 YEARS +/¿ 12.4 YEARS) WERE INCLUDED. TO CONFIRM THE CEREBRAL LARGE-VESSEL OCCLUSION (LVO), AN IMPRESS DIAGNOSTIC PERIPHERAL CATHETER (MERIT MEDICAL) WAS PLACED IN AN 8F RADIFOCUS SUPER ARROW-FLEX SHEATH INTRODUCER (ARROW INTERNATIONAL INC.). THE DIAGNOSTIC CATHETER WAS EXCHANGED FOR A GUIDING CATHETER, SUCH AS NEURON MAX (PENUMBRA, INC., ALAMEDA, CA, USA) OR FUBUKI (TERUMO-MICROVENTION). THE FOLLOWING ASPIRATION CATHETERS WERE USED IN THIS STUDY: THE REACT 68 AND REACT 71 (MEDTRONIC); SOFIA AND SOFIA PLUS (TERUMO-MICROVENTION); AXS CATALYST 5, 6, AND 7 (STRYKER); OR ACE 68, JET7 (PENUMBRA INC.). A MICROCATHETER HEADWAY 0.021¿ (TERUMO-MICROVENTION) WITH 0.014¿ MICROWIRE TRAXCESS (TERUMO, TOKYO, JAPAN) WAS USED TO REACH THE OCCLUSION SITE. ASPIRATION PASSES WERE PERFORMED USING ADAPT. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE REACT CATHETERS THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: 3 HAD COMPLICATIONS IN THE <(><<)>60 GROUP, 17 IN THE =60 GROUP, 5 IN THE <(><<)>65 GROUP, 15 IN THE =65 GROUP, 13 IN THE <(><<)>80 GROUP, AND 7 IN THE =80 GROUP. - 7 HAD HEMORRHAGE AT 24 HOURS IN THE <(><<)>60 GROUP, 34 IN THE =60 GROUP, 15 IN THE <(><<)>65 GROUP, 27 IN THE =65 GROUP, 31 IN THE <(> <<)>80 GROUP, AND 11 IN THE =80 GROUP. - 2 HAD SAH IN THE <(><<)>60 GROUP, 8 IN THE =60 GROUP, 2 IN THE <(> <<)>65 GROUP, 8 IN THE =65 GROUP, 4 IN THE <(><<)>80 GROUP, AND 6 IN THE =80 GROUP. - 1 HAD ICH IN THE <(><<)>60 GROUP, 1 IN THE =60 GROUP, 2 IN THE <(> <<)>65 GROUP, 0 IN THE =65 GROUP, 2 IN THE <(><<)>80 GROUP, AND 0 IN THE =80 GROUP. - 1 HAD VASOSPASM IN THE <(><<)>60 GROUP, 3 IN THE =60 GROUP, 1 IN THE <(><<)>65 GROUP, 3 IN THE =65 GROUP, 4 IN THE <(><<)>80 GROUP, AND 0 IN THE =80 GROUP. - 0 HAD EMBOLIZATION IN A NEW TERRITORY IN THE <(><<)>60 GROUP, 11 IN THE =60 GROUP, 3 IN THE <(><<)>65 GROUP, 8 IN THE =65 GROUP, 9 IN THE <(><<)>80 GROUP, AND 2 IN THE =80 GROUP. - 0 HAD DISSECTION IN THE <(><<)>60 GROUP, 4 IN THE =60 GROUP, 0 IN THE <(><<)>65 GROUP, 4 IN THE =65 GROUP, 3 IN THE <(><<)>80 GROUP, AND 1 IN THE =80 GROUP. - 7 DIDN'T HAVE MTICI 2B-3 IN THE <(><<)>60 GROUP, 50 IN THE =60 GROUP, 15 IN THE <(><<)>65 GROUP, 42 IN THE =65 GROUP, 42 IN THE <(><<)>80 GROUP, AND 15 IN THE =80 GROUP. -MRS WAS 0 AT DISCHARGE FOR 4 IN THE <(><<)>60 GROUP, 7 IN THE =60 GROUP, 5 IN THE <(><<)>65 GROUP, 6 IN THE =65 GROUP, 10 IN THE <(><<)>80 GROUP, AND 1IN THE =80 GROUP -MRS WAS 1 AT DISCHARGE FOR 5 IN THE <(><<)>60 GROUP, 14 IN THE =60 GROUP, 6 IN THE <(><<)>65 GROUP, 13 IN THE =65 GROUP, 15 IN THE <(> <<)>80 GROUP, AND 4 IN THE =80 GROUP -MRS WAS 2 AT DISCHARGE FOR 4 IN THE <(><<)>60 GROUP, 17 IN THE =60 GROUP, 9 IN THE <(><<)>65 GROUP, 12 IN THE =65 GROUP, 19 IN THE <(> <<)>80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 3 AT DISCHARGE FOR 3 IN THE <(><<)>60 GROUP, 10 IN THE =60 GROUP, 6 IN THE <(><<)>65 GROUP, 7 IN THE =65 GROUP, 12 IN THE <(><<)>80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 4 AT DISCHARGE FOR 1 IN THE <(><<)>60 GROUP, 11 IN THE =60 GROUP, 2 IN THE <(><<)>65 GROUP, 10 IN THE =65 GROUP, 8 IN THE <(><<)>80 GROUP, AND 4 IN THE =80 GROUP -MRS WAS 5 AT DISCHARGE FOR 7 IN THE <(><<)>60 GROUP, 38 IN THE =60 GROUP, 14 IN THE <(><<)>65 GROUP, 31 IN THE =65 GROUP, 33 IN THE <(> <<)>80 GROUP, AND 12 IN THE =80 GROUP -MRS WAS 6 AT DISCHARGE FOR 5 IN THE <(><<)>60 GROUP, 30 IN THE =60 GROUP, 9 IN THE <(><<)>65 GROUP, 26 IN THE =65 GROUP, 26 IN THE <(> <<)>80 GROUP, AND 9 IN THE =80 GROUP -MRS WAS 0 AT 30 DAYS FOR 3 IN THE <(><<)>60 GROUP, 8 IN THE =60 GROUP, 4 IN THE <(><<)>65 GROUP, 7 IN THE =65 GROUP, 9 IN THE <(><<)>80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 1 AT 30 DAYS FOR 6 IN THE <(><<)>60 GROUP, 9 IN THE =60 GROUP, 6 IN THE <(><<)>65 GROUP, 9 IN THE =65 GROUP, 14 IN THE <(><<)>80 GROUP, AND 1IN THE =80 GROUP -MRS WAS 2 AT 30 DAYS FOR 3 IN THE <(><<)>60 GROUP, 16 IN THE =60 GROUP, 7 IN THE <(><<)>65 GROUP, 12 IN THE =65 GROUP, 17 IN THE <(><<)>80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 3 AT 30 DAYS FOR 3 IN THE <(><<)>60 GROUP, 18 IN THE =60 GROUP, 8 IN THE <(><<)>65 GROUP, 13 IN THE =65 GROUP, 19 IN THE <(><<)>80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 4 AT 30 DAYS FOR 0 IN THE <(><<)>60 GROUP, 12 IN THE =60 GROUP, 2 IN THE <(><<)>65 GROUP, 10 IN THE =65 GROUP, 8 IN THE <(><<)>80 GROUP, AND 4 IN THE =80 GROUP -MRS WAS 5 AT 30 DAYS FOR 8 IN THE <(><<)>60 GROUP, 33 IN THE =60 GROUP, 15 IN THE <(><<)>65 GROUP, 26 IN THE =65 GROUP, 31 IN THE <(><<)>80 GROUP, AND 10 IN THE =80 GROUP -MRS WAS 6 AT 30 DAYS FOR 5 IN THE <(><<)>60 GROUP, 24 IN THE =60 GROUP, 7 IN THE <(><<)>65 GROUP, 22 IN THE =65 GROUP, 21 IN THE <(><<)>80 GROUP, AND 8 IN THE =80 GROUP -MRS WAS 0 AT 90 DAYS FOR 1 IN THE <(><<)>60 GROUP, 5 IN THE =60 GROUP, 1 IN THE <(><<)>65 GROUP, 5 IN THE =65 GROUP, 4 IN THE <(><<)>80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 1 AT 90 DAYS FOR 5 IN THE <(><<)>60 GROUP, 9 IN THE =60 GROUP, 6 IN THE <(><<)>65 GROUP, 8 IN THE =65 GROUP, 14 IN THE <(><<)>80 GROUP, AND 0 IN THE =80 GROUP -MRS WAS 2 AT 90 DAYS FOR 5 IN THE <(><<)>60 GROUP, 17 IN THE =60 GROUP, 10 IN THE <(><<)>65 GROUP, 12 IN THE =65 GROUP, 19 IN THE <(><<)>80 GROUP, AND 3 IN THE =80 GROUP -MRS WAS 3 AT 90 DAYS FOR 0 IN THE <(><<)>60 GROUP, 11 IN THE =60 GROUP, 2 IN THE <(><<)>65 GROUP, 9 IN THE =65 GROUP, 9 IN THE <(><<)>80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 4 AT 90 DAYS FOR 2 IN THE <(><<)>60 GROUP, 12 IN THE =60 GROUP, 5 IN THE <(><<)>65 GROUP, 9 IN THE =65 GROUP, 13 IN THE <(><<)>80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 5 AT 90 DAYS FOR 3 IN THE <(><<)>60 GROUP, 11 IN THE =60 GROUP, 6 IN THE <(><<)>65 GROUP, 8 IN THE =65 GROUP, 12 IN THE <(><<)>80 GROUP, AND 2 IN THE =80 GROUP -MRS WAS 6 AT 90 DAYS FOR 1 IN THE <(><<)>60 GROUP, 18 IN THE =60 GROUP, 2 IN THE <(><<)>65 GROUP, 17 IN THE =65 GROUP, 10 IN THE <(><<)>80 GROUP, AND 9 IN THE =80 GROUP -MRS WAS 0 AT 12 MONTHS FOR 1 IN THE <(><<)>60 GROUP, 1 IN THE =60 GROUP, 1 IN THE <(><<)>65 GROUP, 1 IN THE =65 GROUP, 2 IN THE <(><<)>80 GROUP, AND 0 IN THE =80 GROUP -MRS WAS 1 AT 12 MONTHS FOR 6 IN THE <(><<)>60 GROUP, 6 IN THE =60 GROUP, 6 IN THE <(><<)>65 GROUP, 6 IN THE =65 GROUP, 12 IN THE <(><<)>80 GROUP, AND 0 IN THE =80 GROUP -MRS WAS 2 AT 12 MONTHS FOR 0 IN THE <(><<)>60 GROUP, 10 IN THE =60 GROUP, 5 IN THE <(><<)>65 GROUP, 5 IN THE =65 GROUP, 9 IN THE <(><<)>80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 3 AT 12 MONTHS FOR 2 IN THE <(><<)>60 GROUP, 7 IN THE =60 GROUP, 4 IN THE <(><<)>65 GROUP, 5 IN THE =65 GROUP, 8 IN THE <(><<)>80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 4 AT 12 MONTHS FOR 0 IN THE <(><<)>60 GROUP, 4 IN THE =60 GROUP, 1 IN THE <(><<)>65 GROUP, 3 IN THE =65 GROUP, 3 IN THE <(><<)>80 GROUP, AND 1 IN THE =80 GROUP -MRS WAS 5 AT 12 MONTHS FOR 0 IN THE <(><<)>60 GROUP, 1 IN THE =60 GROUP, 0 IN THE <(><<)>65 GROUP, 1 IN THE =65 GROUP, 1 IN THE <(><<)>80 GROUP, AND 0 IN THE =80 GROUP -MRS WAS 6 AT 12 MONTHS FOR 1 IN THE <(><<)>60 GROUP, 15 IN THE =60 GROUP, 3 IN THE <(><<)>65 GROUP, 13 IN THE =65 GROUP, 9 IN THE <(><<)>80 GROUP, AND 7 IN THE =80 GROUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 512562 | REACT CATHETER | CATHETER, PERCUTANEOUS | DQY | MICRO THERAPEUTICS, INC. DBA EV3 | REACT-68 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Death | SEE H11... |