UNKNOWN SOLITAIRE
Report
- Report Number
- 2029214-2023-00141
- Event Type
- Injury
- Date Received
- January 31, 2023
- Date of Event
- August 28, 2018
- Report Date
- February 27, 2023
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- NRY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 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.
ANJA HANSER,LUDGER SIEVERDING, TILL-KARSTEN HAUSER, GESA WIEGAND, MICHAEL HOFBECK; CATHETERIZATION <(>&<)> CARDIOVASCULAR INTERVENTIONS; 2019; 93:E357¿E361; STENT-RETRIEVER THROMBECTOMY IN THE TREATMENT OF INFANTS WITH ACUTE THROMBOSIS OF THE SUPERIOR VENA CAVA AND INNOMINATE VEIN; DOI: 10.1002/CCD.28142 MEDTORNIC RECIEVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENT TREATED WITH A SOLITAIRE 6/20MM SAW IMPROVEMENT IN REESTABLISHING FLOW FROM A THROMBECTOMY BUT REQURED ADDITIONAL TREATMENT. THE PURPOSE OF THE STUDY WAS TO DESCRIBE THE EFFICACY AND SAFETY OF STENT-RETRIEVER THROMBECTOMY IN INFANTS WITH THROMBOSIS OF THE SUPERIOR VENA CAVA (SVC) AND INNOMINATE VEIN. ONE PATIENT WAS TREATED WITH A SOLITIARE STENT. PROCEDURE: ACCESS WAS GAINED PERCUTANEOUSLY FROM THE RIGHT OR LEFT FEMORAL VEIN USING 4 AND 5 FRENCH SHEATHS. SUPPORTED BY A 0.03500 TERUMO WIRE WE ADVANCED A 4 FRENCH OR 5 FRENCH CATHETER INTO THE THROMBUS. THE STENT-RETRIEVER SYSTEM WAS CHOSEN TO MATCH THE DIAMETER OF THE THROMBOSED VESSEL. THE SYSTEM IS INTRODUCED VIA AN INSERTION TUBE INTO THE GUIDING CATHETER, THE PROXIMAL END OF WHICH IS SECURED BY A ROTATING HEMOSTATIC VALVE. DISTAL RADIOPAQUE MARKERS ALLOW TO CONTROL THE POSITION OF THE STENT, WHICH IS ADVANCED TO THE DISTAL END OF THE GUIDING CATHETER. WHILE THE PUSHER WIRE IS FIXED TO MAINTAIN THE POSITION OF THE SYSTEM, THE GUIDING CATHETER IS WITHDRAWN BEYOND THE PROXIMAL END OF THE STENT ALLOWING EXPANSION OF THE STRUTS. THEY LEFT THE STENT IN PLACE FOR SEVERAL MINUTES TO ALLOW INTEGRATION OF THROMBOTIC MATERIAL INTO THE STRUTS OF THE STENT. TO RETRIEVE THE THROMBUS THE STENT-RETRIEVER SYSTEM WAS SLOWLY WITHDRAWN INTO THE GUIDING CATHETER APPLYING ASPIRATION VIA THE SIDE ARM OF THE ROTATING HEMOSTATIC VALVE USING A SYRINGE. THE STENT WAS EXTERIORIZED TO REMOVE THROMBOTIC MATERIAL OF THE CLOT ADHERING TO THE STRUTS OF THE STENT. THE PROCEDURE WAS REPEATED 4¿6 TIMES, UNTIL ADEQUATE FLOW WAS RESTORED IN THE AFFECTED VESSELS. THEY PERFORMED THE SAME MANOEUVERS TO OPEN THE INNOMINATE VEIN AND THROMBOSED INTERNAL JUGULAR AND SUBCLAVIAN VEINS. SIGNIFICANT RESIDUAL THROMBOTIC MATERIAL WAS DETECTED ADHERING TO THE WALL OF THE SVC OR INNOMINATE VEIN, THEY PERFORMED BALLOON DILATATION WITH 5 MM/20 MM OR 8 MM/30 MM TYSHAK® II BALLOONS OR 7/40 MM SENRI® B ALLOON TO IMPROVE FLOW BY COMPRESSION OF THROMBOTIC MATERIAL. RESULTS: INTERVENTIONAL TREATMENT RESULTED IN ESTABLISHMENT OF FLOW IN THE SVC, INNOMINATE AND BRACHIOCEPHALIC VEINS IN ALL PATIENTS AND WAS PERFORMED WITHOUT COMPLICATIONS. THE POSTINTERVENTIONAL COURSE WAS UNEVENTFUL AND NONE OF OUR PATIENTS REQUIRED TRANSFUSION DUE TO PERIPROCEDURAL BLOOD LOSS. NONE OF OUR PATIENTS SHOWED EVIDENCE OF PULMONARY OR SYSTEMIC EMBOLI. REPEAT EXAMINATIONS OF CEREBRAL ULTRASOUND IN BOTH OF OUR PATIENTS WITH FUNCTIONAL UNIVENTRICULAR HEARTS REVEALED NO EVIDENCE OF CEREBRAL EMBOLIZATION OR BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 897043 | UNKNOWN SOLITAIRE | CATHETER, THROMBUS RETRIEVER | NRY | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-SOLITAIRE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 DA | Male | Required Intervention |