CONCERTO COIL
Report
- Report Number
- 2029214-2019-00761
- Event Type
- Malfunction
- Date Received
- July 19, 2019
- Report Date
- September 26, 2019
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRD
- UDI-DI
- 00847536013360
- PMA / PMN Number
- K090046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
UPDATED SECTIONS: A-2:AGE, A-3: SEX, B-5:ADDITIONAL EVENT DETAILS. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. 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. 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.
H3: THERE WAS NO INSTANT DETACHER, MICRO CATHETER, OR ACCESSORIES RETURNED WITH THE DEVICE. THE ACTUATOR INTERFACE WAS SECURELY ATTACHED TO THE COUPLER TUBE BUT FOUND TO BE BENT AT THE JOINT. THE POSITIVE LOAD INDICATOR, COUPLER TUBE, BREAK INDICATOR AND ALL CRIMPS WERE FOUND TO BE INTACT. THERE IS NO EVIDENCE OF ANY DETACHMENT ATTEMPTS BY MECHANICAL OR MANUAL METHODS. THE CONCERTO PUSHWIRE WAS FOUND BENT AT ~63.6CM FROM THE PROXIMAL END. THE COIN WAS PRESENT AND AGAINST THE LUMEN STOP. THE SHIELD COIL WAS PRESENT AND INTACT. THE DETACH ELEMENT BALL WAS STILL ATTACHED TO THE PUSHWIRE WITH THE DETACH ELEMENT STICK AND LOOP BROKEN OFF WITH THE IMPLANT COIL. THE IMPLANT COIL AND THE BROKEN PART OF THE DETACH ELEMENT WERE NOT RETURNED FOR ANALYSIS. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS PERFORMED THE CONCERTO COIL WAS NOT CONFIRMED TO HAVE PREMATURELY DETACHED AS THE DETACH ELEMENT WAS STILL ATTACHED. THE IMPLANT COIL WAS FOUND TO BE BROKEN OFF FROM THE DETACH ELEMENT, HOWEVER THE CAUSE OF THE COIL BREAK CANNOT BE DETERMINED. IT IS LIKELY CUSTOMER MISIDENTIFIED THE BROKEN IMPLANT AS A PREMATURE DETACHMENT. POSSIBLE CAUSES FOR ¿COIL SEPARATION/BREAK¿ ARE: TORTUOUS ANATOMY, COIL IS NOT RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING, PUSHWIRE ROTATION, AND USER ADVANCES THE COIL AGAINST RESISTANCE. SINCE THE MICRO CATHETER WAS NOT RETURNED, ANY CONTRIBUTION OF THE MICRO CATHETER (OTHER THAN COMPATIBILITY) TO THE ISSUE COULD NOT BE DETERMINED. CUSTOMER REPORTED USING A TERUMO 2.8F PROGREAT MICRO CATHETER. THE PROGREAT 2.8F HAS AN INNER DIAMETER OF 0.027¿ (PER TERUMO WEBSITE), WHICH IS COMPATIBLE WITH THE CONCERTO COIL PER INSTRUCTION FOR USE: CONCERTO DETACHABLE COIL SYSTEM TO BE USED WITH ¿MINIMUM MICRO CATHETER INSIDE DIAMETER OF 0.0165¿ WITH TWO MARKER BANDS¿. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A MANUFACTURING ISSUE AND NO DEVICE HISTORY RECORD WAS REQUESTED, THEREFORE A DHR REVIEW WAS NOT REQUIRED. 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 RECEIVED REPORT THAT THIS EVENT OCCURRED DURING THE TREATMENT OF A RIGHT GASTRIC ARTERY. IT IS UNKNOWN IF THE DEVICE WERE PREPARED AND USED EXACTLY AS PER THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED WITH NEW DEVICES.
THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE. HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. NO CORRECTIVE ACTION. MONITORING AND TRENDING THIS TYPE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED REPORT THAT ONE COIL DEPLOYED IN THE MICROCATHETER. THERE WAS NO ALLEGATION THAT A PATIENT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600090 | CONCERTO COIL | DEVICE, EMBOLIZATION, VASCULAR | KRD | MICRO THERAPEUTICS, INC. DBA EV3 | NV-3-4-HELIX | A810996 | 00847536013360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |