LRS INSTANT DETACHER
Report
- Report Number
- 2029214-2023-00684
- Event Type
- Death
- Date Received
- April 24, 2023
- Date of Event
- April 22, 2023
- Report Date
- October 10, 2023
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- HCG
- PMA / PMN Number
- K060747
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H3: PRODUCT ANALYSIS#: (B)(4): EQUIPMENT USED: VIDEO INSPECTION SYSTEM (M-85519) WITH MICROSCOPE, RULER (M-83361), CAMERA (PANASONIC LUMIX DMC-ZS5); IN-HOUSE COIL QC-2.5-4 HELIX LOT: A280588, DRAWING(S) REFERENCED: DWGS30914 REV. G, AS FOUND CONDITION: THE INSTANT DETACHER WAS RETURNED FOR EVALUATION WITHIN THE INNER POUCH; INSIDE A BIOHAZARD PLASTIC BAG AND A SHIPPING BOX,. DAMAGE LOCATION DETAILS: VISUAL INSPECTION OF THE ASSEMBLED INSTANT DETACHER SHOWED NO DEFECTS. TESTING/ANALYSIS: AN IN-HOUSE AXIUM COIL WAS THEN SELECTED FOR TESTING WITH THE INSTANT DETACHER. NO DIFFICULTY WAS EXPERIENCED INSERTING THE PROXIMAL END OF PUSHWIRE INTO THE INSTANT DETACHER, AND THE LOAD INDICATOR WAS NOT VISIBLE WHEN THE PUSHWIRE WAS FULLY SEATED IN THE INSTANT DETACHER CAP. THE IMPLANT COIL WAS SUCCESSFULLY DETACHED ON THE FIRST ATTEMPT WITHOUT ANY DIFFICULTY. DURING EVALUATION, THE INSTANT DETACHER WAS TAKEN APART TO EVALUATE THE COMPONENTS. ALL COMPONENTS APPEARED TO BE NORMAL. THE SURFACE AROUND THE BOTTOM INNER DIAMETER OF THE INSTANT DETACHER CAP APPEARED TO BE CLEAN. THE INSTANT DETACHER CAP BOTTOM INNER DIAMETER WAS MEASURED TO BE 0.0140¿ WHICH IS WITHIN SPECIFICATIONS. NO OTHER ANOMALIES WERE OBSERVED. CONCLUSION: BASED ON THE ANALYSIS FINDINGS AND THE REPORTED EVENT DETAILS, THE INSTANT DETACHER WAS NOT CONFIRMED TO HAVE "UNABLE TO DETACH" ISSUE. THE ROOT CAUSE COULD NOT BE DETERMINED AS NO DEFECT WAS FOUND WITH THE RETURNED INSTANT DETACHER. THE RETURNED INSTANT DETACHER WAS USED TO SUCCESSFULLY DETACH THE IN-HOUSE COIL WITH NO ISSUE. LS 2023-07-17. 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.
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.
ASSOCIATED WITH MDR#: 2029214-2023-00683. B5. UPDATED WITH ADDITIONAL INFORMATION RECEIVED. H6. DEVICE EVAL CONCLUSION CODE ADDED BASED ON PREVIOUSLY REPORTED DEVICE ANALYSIS AND 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.
SEE MANUFACTURER REPORT # 2029214-2023-00683 FOR THE COIL INVOLVED IN THIS EVENT. 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.
ADDITIONAL INFORMATION RECEIVED REPORT THE PATIENT DIED IN THE INTENSIVE CARE UNIT (ICA). IT WAS NOTED THAT THE PATIENT'S DEATH WAS "DUE TO ANOTHER PATHOLOGY" AND WAS NOT RELATED TO THE AXIUM COIL DETACHMENT ISSUES.
MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS UNABLE TO BE DETACHED AND THEN DETACHED INSIDE THE CATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER AND NECK DIAMETER WERE 2MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE DOCTOR INSERTED THE MICROCATHETER WITH THE MICROGUIDE AND POSITIONED IT IN THE ANEURYSM, REMOVED THE MICROGUIDE AND INSERTED THE COIL PREVIOUSLY HYDRATED BY THE MICROCATHETER THEY BEGAN TO DETACH IT INSIDE THE ANEURYSM UNTIL THE 3D BASKET WAS ASSEMBLED. THEY TRIED RELEASING THE COIL WITH THE INSTANT DETACHER. A SECOND INSTANT DETACHER WAS ALSO USED, BUT THE COIL COULD NOT BE DETACHED. NO DETACHMENT ATTEMPTS WERE MADE WITH THE MANUAL METHOD. IT WAS STATED THAT THERE WERE NO PROBLEMS WITH THE INSTANT DETACHER. THEY THEN BEGAN TO WITHDRAW THE PUSHER FROM THE COIL, AND WHEN IT HAS WITHDRAWN A LITTLE MORE THAN 3CM, IT BEGAN TO DISARM AND RETRACT THROUGH THE MICROCATHETER. THE DOCTOR TRIED TO PUSH IT TO INSERT IT INSIDE THE ANEURYSM, BUT THEY HAD NO CONTROL OF THE COILS BECAUSE IT WAS ONLY HOLDING ONTO THE FILAMENT. AFTER THIS, THE COIL CAME OUT OF THE ANEURYSM AND IMMEDIATELY TRAVELED TO THE CALLOSOMARGINAL ARTERY, COMPLETELY OCCLUDING IT. THE DOCTOR IMMEDIATELY A SOLITAIRE STENT RETRIEVER AND MANAGED TO CAPTURE AND EXTRACT THE COIL. THEY PERFORMED A CONTROL IMAGE AND COMPLETE OCCLUSION OF THE CALLOSOMARGINAL ARTERY WAS OBSERVED. THEY PROCEEDED TO OCCLUDE THE ANEURYSM WITH ANOTHER COIL, AND LATER TRIED TO UNCOVER THE CALLOSOMARGINAL ARTERY WITH CHEMICAL THROMBOLYSIS WITHOUT SUCCESSFULLY MAKING IT PERMEABLE. THE PATIENT EXPERIENCED A STROKE. ALL SYSTEMS ARE REMOVED AND THE PATIENT WAS TRANSFERRED TO THE ICU. THE PATIENT STATUS WAS NOTED TO BE ALIVE WITH INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DIED ON (B)(6) 2023, WITH A DIAGNOSIS OF SUDDEN DEATH. THERE WAS NO PROBLEM BEFORE THE COILS CAME OFF. NO DAMAGE WAS OBSERVED, THE COIL APPEARED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1164262 | LRS INSTANT DETACHER | DEVICE, NEUROVASCULAR EMBOLIZATION | HCG | MICRO THERAPEUTICS, INC. DBA EV3 | ID-1-5 | B418853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Life Threatening| R| H| D |