REACT CATHETER
Report
- Report Number
- 2029214-2022-00115
- Event Type
- Injury
- Date Received
- January 28, 2022
- Date of Event
- January 21, 2021
- Report Date
- November 30, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- DQY
- PMA / PMN Number
- K182097
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- 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.
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.
ADDITIONAL INFORMATION RECEIVED REPORTED SITE HAS UPDATED THE DATA TO REACT-68 LOT A982880.
MEDTRONIC RECEIVED A REPORT THAT A CT SCAN ON (B)(6) 2021 24 HOURS AFTER A SOLITAIRE PROCEDURE SHOWED AN EXPANSION OF THE INDEX INFARCT. AN MRI AND RADIOGRAPHY SHOWED A MASS EFFECT WITH MID-LINE SHIFT OF 7 MM. THE PATIENT DID NOT EXPERIENCE ANY INJURY, SYMPTOMS, OR COMPLICATIONS. THE DEVICE WAS USED PER STANDARD OF CARE. THE PATIENT¿S BASELINE NIHSS SCORE WAS 18. THE INITIAL CLOT WAS AT RIGHT MCA-M1. EXTRA CRANIAL ANGIOPLASTY BEFORE THE MECHANICAL THROMBECTOMY AND EXTRACRANIAL CERVICAL ICA STENTING AFTER MECHANICAL THROMBECTOMY WAS PERFORMED. AN MTICI SCORE OF 3 WAS ACHIEVED AT PASS # 1. TWENTY-FOUR HOURS POST PROCEDURE THE PATIENT¿S NIHSS SCORE WAS 9, AND AT DISCHARGE IT WAS 5. ANCILLARY DEVICES INCLUDE A REACT 71 CATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THE CORE-LAB IMAGE SHOWED A NEW ACUTE ISCHEMIC INFARCTION IN A PRIMARY UNAFFECTED VASCULAR TERRITORY IN THE PCA AND THE RIGHT ICA WITH RE-OCCLUSION OF THE RIGHT PCA IN THE CTA ON (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS THROMBOSIS OF THE STENT LOCATED IN THE C1 SEGMENT OF THE RIGHT ICA WITHOUT DISTAL PATENCY. THE EVENT WAS NO THE RESULT OF A DEVICE DEFICIENCY, AND THIS WAS NOT A NEW OR RECURRENT STROKE. THE PATIENT'S MRS SCORE WAS 2 AND THEIR NIHSS SCORE WAS 18. THE EVENT RESOLVED WITH SEQUELAE ON (B)(6) 2021. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE PROCEDURE.
ADDITIONAL INFORMATION RECEIVED REPORTED GREATER HYPODENSITY IN RELATION TO AREAS OF ESTABLISHED ACUTE INFARCTION WITH DEVIATION OF THE MIDLINE STRUCTURES 4 MM AND STENT THROMBOSIS RE-OCCLUSION OF RIGHT ICA ON 24 HOUR POST-PROCEDURE IMAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1685238 | REACT CATHETER | CATHETER, PERCUTANEOUS | DQY | MICRO THERAPEUTICS, INC. DBA EV3 | REACT-71 | A982880 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Other |