REACT CATHETER
Report
- Report Number
- 2029214-2021-01634
- Event Type
- Injury
- Date Received
- December 20, 2021
- Date of Event
- December 7, 2021
- Report Date
- January 4, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- DQY
- PMA / PMN Number
- K180715
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THIS IS NO LONGER CONSIDERED A REPORTABLE EVENT. MDR DECISION CORRECT TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS WILL BE SUBMITTED UNLESS ADDITIONAL INFORMATION OBTAINED INDICATES A REPORTABLE EVENT. DUE TO GCH FUNCTIONALITY, THE COMPLAINT FLAG CANNOT BE FLIPPED TO "NO" AS A REGULATORY REPORT EXISTS IN THIS PE. H6. CODING UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED. 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPORT OF UNSUCCESSFUL THROMBECTOMY WAS A DATA ENTRY ERROR. THERE WAS UNSUCCESSFUL THROMBECTOMY TO BE REPORTED AND NO DEVICE DEFICIENCY. THIS IS NO LONGER CONSIDERED A REPORTABLE EVENT. MDR DECISION CORRECT TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS WILL BE SUBMITTED UNLESS ADDITIONAL INFORMATION OBTAINED INDICATES A REPORTABLE EVENT. DUE TO GCH FUNCTIONALITY, THE COMPLAINT FLAG CANNOT BE FLIPPED TO "NO" AS A REGULATORY REPORT EXISTS IN THIS PE.
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN UNSUCCESSFUL THROMBECTOMY. THE SITE REPORTED THAT THERE WERE INTERVENTIONS PERFORMED BEYOND THE MECHANICAL THROMBECTOMY AND IVA TPA AS INTRAARTERIAL TIROFIBAN 10MG, AFTER THE MECHANICAL THROMBECTOMY. THE REASON FOR THE INTERVENTION WAS UNKNOWN. THE PATIENT'S MTICI WAS 0 AT THE END OF PASS #1 AND #2. DURING PASS #2, THE MT TYPE WAS CHANGED FROM ASPIRATION REACT ONLY TO A COMBINATION OF REACT AND SOLITAIRE. THE REASON FOR THE CHANGE WAS DUE TO UNSUCCESSFUL THROMBECTOMY. THE THIRD PASS THE CERENVOUS NIMBUS DEVICE WAS USED ALONG WITH THE REACT AND THE FINAL TICI SCORE 2B WAS ACHIEVED. THE MECHANICAL THROMBECTOMY WAS FOR AIS TREATMENT FOR AN ISCHEMIC STROKE. THE PATIENT'S MRS BASELINE WAS 1, THE PROCEDURE MRS SCORE WAS UNKNOWN THE PATIENT'S NIHSS SCORE BASELINE WAS 8 AND THE POST-PROCEDURE SCORE WAS NOT APPLICABLE. THE PATIENT'S TICI SCORE BASELINE WAS 0 AND THE POST-PROCEDURE SCORE WAS 2B. AN IV TPA WAS CONTRAINDICATED AND THREE PASSES WERE MADE WITH THE DEVICE. THE STROKE ONSET WAS 23:00 ON (B)(6) 2021 AND REPERFUSION TIME: 12:55 ON (B)(6) 2021.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1940489 | REACT CATHETER | CATHETER, PERCUTANEOUS | DQY | MICRO THERAPEUTICS, INC. DBA EV3 | REACT-68 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Female | Required Intervention |