UNKNOWN SOLITAIRE
Report
- Report Number
- 2029214-2024-00059
- Event Type
- Injury
- Date Received
- January 9, 2024
- Date of Event
- December 22, 2022
- Report Date
- February 23, 2024
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- NRY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G2: CITATION: AUTHORS: NARIAI, Y., TAKIGAWA, T., KAWAMURA, Y., HYODO, A., <(>&<)> SUZUKI, K.. NARIAI Y, TAKIGAWA T, KAWAMURA Y, HYODO A, SUZUKI K. POSSIBLE CONTRIBUTION OF THE ASPIRATION CATHETER IN PREVENTING POST-STENT RETRIEVER THROMBECTOMY SUBARACHNOID HEMORRHAGE. CLINICAL NEURORADIOLOGY:. CLINICAL NEURORADIOLOGY: OFFICIAL JOURNAL OF THE GERMAN, AUS 2 2023. DOI:10.1007/S00062-022-01240-4 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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 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.
NARIAI Y, TAKIGAWA T, KAWAMURA Y, HYODO A, SUZUKI K. POSSIBLE CONTRIBUTION OF THE ASPIRATION CATHETER IN PREVENTING POST-STENT RETRI EVER THROMBECTOMY SUBARACHNOID HEMORRHAGE. CLINICAL NEURORADIOLOGY: OFFICIAL JOURNAL OF THE GERMAN, AUSTRIAN, AND SWISS SOCIETIES OF NEURORADIOLOGY. 2023;33(2):509-518. DOI:10.1007/S00062-022-01240-4. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF POST-THROMBECTOMY SUBARACHNOID HEMORRHAGE IN ASSOCIATION WITH THE SOLITAIRE STENT. THE PURPOSE OF THIS ARTICLE WAS TO IDENTIFY FACTORS RELATED TO THE INCIDENCE OF POST-THROMBECTOMY SUBARACHNOID HEMORRHAGE (PTSAH). THIS RETROSPECTIVE, OBSERVATIONAL COHORT STUDY ENROLLED CONSECUTIVE PATIENTS WITH ACUTE ISCHEMIC STROKE (AIS) DUE TO THE INTERNAL CAROTID ARTERY (IC) TOP OR MIDDLE CEREBRAL ARTERY (MCA) M1 OR M2 SEGMENT OCCLUSION WHO UNDERWENT SINGLE-PASS STENT RETRIEVER (SR) TREATMENT BETWEEN JANUARY 2015 AND MAY 2022 AT TWO ACUTE CARE HOSPITALS. ACCORDING TO THE PRESENCE OF PTSAH, THE PATIENTS WERE DIVIDED INTO TWO GROUPS (THE PTSAH GROUP AND THE NON-PTSAH GROUP). OF THE 54 INCLUDED PATIENTS, 10 WERE IN THE PTSAH GROUP (18.5%). THE STUDY POPULATION HAD A MEAN AGE OF 75.3 YEARS (RANGE 46¿92 YEARS) AND INCLUDED 22 WOMEN (40.7%). ALL PROCEDURES WERE PERFORMED UNDER LOCAL ANESTHESIA VIA THE FEMORAL ARTERY. A 25-CM 9 FRENCH (FR) OR 8 FR SHEATH WAS PLACED IN A FEMORAL SITE. BALLOON GUIDE CATHETERS (BGCS) (OPTIMO CATHETER) WERE USED IN ALL CASES AND ADVANCED UP TO THE CERVICAL PORTION OF THE IC OR COMMON CAROTID ARTERY DEPENDING ON VESSEL TORTUOSITY FROM AORTA. THE MICROCATHETERS WERE DISTALLY DELIVERED BEYOND THE CLOT USING A J-CONFIGURED (THE CURVE AT THE TIP OF THE WIRE) MICROWIRE (ASAHI CHIKAI 14) TO PRECLUDE SELECTION OF SMALL BRANCHES WHICH COULD LEAD TO HEMORRHAGIC OR ISCHEMIC COMPLICATIONS. SUBSEQUENTLY, THE ASPIRATION CATHETER (AC) WAS ADVANCED AS FAR AS POSSIBLE INTRACRANIALLY TOWARD THE CLOT INTERFACE IN THE AC USE CASES BEFORE DEPLOYMENT OF THE SR. AMONG STENT RETRIEVER TREATMENT (SRT) CASES WITH AN AC, THE COMBINED GROUP INCLUDED CASES IN WHICH AN AC WAS ADVANCED AT LEAST TO THE MOST PROXIMAL MARKER OF AN SR. IN ADDITION, IF POSSIBLE, THE AC WAS ADVANCED UNTIL IT WAS ENGAGED BY THE PROXIMAL THROMBUS. SRT WAS PERFORMED USING SOLITAIRE (MEDTRONIC NEUROVASCULAR) IN 30 CASES (6 CASE WITH PTSAH), TREVO (STRYKER NEUROVASCULAR) IN 21 CASES, TRON (JIMRO; TERUMO) IN TWO CASES, AND EMBOTRAP (CERENOVUS, JOHNSON AND JOHNSON MEDICAL DEVICES) IN ONE CASE. ACS WERE USED IN 32 PATIENTS (59.3%), AND THE COMBINED TECHNIQUE WAS ACTUALLY USED IN 26 PATIENTS (48.1%). IN THE COMBINED GROUP, THE CAPTIVE AND ASAP TECHNIQUES WERE USED IN 23 AND 3 CASES, RESPECTIVELY AND 34 PATIENTS (63.0%) HAD A FAVORABLE PROGNOSIS IN THIS STUDY, THE CONTINUOUS ASPIRATION PRIOR TO INTRACRANIAL VASCULAR EMBOLECTOMY (CAPTIVE) TECHNIQUE AND A STENT-RETRIEVING INTO AN AC WITH PROXIMAL BALLOON (ASAP) TECHNIQUE WERE USED AT THE DISCRETION OF THE SURGEONS. THE CONCEPT OF THE CAPTIVE TECHNIQUE IS AS FOLLOWS: AFTER AN SR DEPLOYMENT, AN AC IS ADVANCED UNDER CONTINUOUS ASPIRATION UNTIL THE PROXIMAL THROMBUS CLOGS IT. THE SR AND AC ARE WITHDRAWN INTO THE GUIDING CATHETER AS A SINGLE UNIT . THE CONCEPT OF THE ASAP IS AS FOLLOWS: A BGC IS INFLATED, AND DISTAL ASPIRATION FROM AN AC IS INITIATED BEFORE PASSAGE THROUGH THE THROMBUS TO PREVENT DISTAL EMBOLIZATION. AFTER AN SR IS DEPLOYED, THE AC IS MANEUVERED UP TO A POSITION JUST PROXIMAL TO THE SR. THE SR IS WITHDRAWN INTO THE AC POSITIONED AT THE LOCAL SITE UNTIL THE SR IS COMPLETELY REMOVED FROM THE ENTIRE SYSTEM. FINALLY, THE AC IS REMOVED UNDER CONTINUOUS ASPIRATION AND PROXIMAL FLOW ARREST OF THE BGC. FOLLOW-UP CT AND MRI SCANS WITHIN 24 H OF SRT WERE REVIEWED TO DETERMINE THE PRESENCE OF INTRACRANIAL HEMORRHAGE, INCLUDING PTSAH. SUBARACHNOID HYPERINTENSITY ON FLUID-ATTENUATED INVERSION RECOVERY MRI AND/OR HYPOINTENSITY ON SUSCEPTIBILITY-WEIGHTED IMAGES LOCALIZED TO THE TREATED MCA TERRITORY WERE CONSIDERED POSITIVE FOR PTSAH. SYMPTOMATIC PTSAH WAS DEFINED AS A WORSENING OF THE NIHSS SCORE BY =4 POINTS OR WORSENING BY =2 POINTS IN ONE NIHSS CATEGORY IF ALTERNATIVE EXPLANATIONS FOR THIS DETERIORATION WERE LACKING. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE STENT. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -THE TOTAL RATE OF PTSAH IN THIS STUDY WAS 18.5%. TEN PATIENT'S HAD PTSAH OF WHICH 6 HAD SOLITAIRE STENTS. -IN THE PTSAH GROUP, THERE WAS ONE CASE (1.9%), IN WHICH PTSAH SYMPTOMATICALLY WORSENED THE PATIENT¿S CONDITION. IN THIS CASE, THE C APTIVE TECHNIQUE WAS USED. THE NEUROLOGICAL STATE TEMPORARILY IMPROVED IMMEDIATELY AFTER THE PROCEDURE, BUT THERE WAS A NEUROLOGICAL DECLINE 6 H AFTER THE PROCEDURE. THE CT IMAGE AT THAT TIME SHOWED SYLVIAN HEMATOMA WITH MASS EFFECT WITH AN INCREASE OF 6 POINTS I N THE NIHSS SCORE. FINALLY, THE MRS SCORE AT 3 MONTHS AFTER THE PROCEDURE WAS 5 FOR THE PATIENT.
ADDITIONAL INFORMATION WAS RECEIVED THAT OF THE 10 POST-THROMBECTOMY SUBARACHNOID HEMORRHAGE (PTSAH) CASES, 6 SOLITAIRE STENTS WHICH WERE MANUFACTURED BY MEDTRONIC, WERE RELATED TO THE PTSAH (ADVERSE EVENTS). THE 6 SOLITAIRES WERE COMPOSED OF 4 SOLITAIRE 4*20 MM STENTS, 1 SOLITAIRE 4*40 MM STENT, 1 SOLITAIRE 6*30 MM STENT. OF 6 PTSAH CASES, ONLY ONE CASE WAS SYMPTOMATIC (SOLITAIRE 4*40 MM STENT). WITH REGARD TO USE OF ASPIRATION CATHETERS, ASPIRATION CATHETERS WERE USED IN THE 32 MECHANICAL THROMBECTOMY PROCEDURES. OF THE 32 CASES, REACT71 ASPIRATION CATHETERS WHICH WERE MANUFACTURED BY MEDTRONIC, WERE USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 462434 | UNKNOWN SOLITAIRE | CATHETER, THROMBUS RETRIEVER | NRY | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-SOLITAIRE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Disability |