CONCERTO NYLON
Report
- Report Number
- 2029214-2021-00099
- Event Type
- Malfunction
- Date Received
- January 26, 2021
- Date of Event
- January 22, 2021
- Report Date
- April 5, 2021
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRD
- UDI-DI
- 00847536033566
- PMA / PMN Number
- K090046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
H3: ANALYSIS OF THE CONCERTO COIL (MODEL: NV-5-20-HELIX LOT: B100353) FOUND THAT THE ACTUATOR INTERFACE WAS BROKEN FROM THE COUPLER TUBE AND NOT RETURNED. THE CONCERTO PUSHER WAS FOUND BROKEN AT THE POSITIVE LOAD INDICATOR AND DISTAL TO THE POSITIVE LOAD INDICATOR, WITH THE SEGMENTS RETAINED BY THE RELEASE WIRE. IT IS LIKELY DETACHMENT WAS ATTEMPTED AT THESE LOCATIONS. THE BREAK INDICATOR WAS FOUND INTACT. NO DETACHMENT WAS ATTEMPTED AT THIS LOCATION. THE COIN WAS FOUND AGAINST THE LUMEN STOP. THE SHIELD COIL WAS FOUND INTACT, AND THE IMPLANT COIL WAS STILL ATTACHED. THE EXPOSED RELEASE WIRE WAS RETRACTED AND FOUND TO BE BROKEN AT ~66.5 CM FROM THE PROXIMAL END. THE DISTAL OUTER JACKET WAS REMOVED, AND DRIED BLOOD WAS FOUND WITHIN THE JACKET AND LUMEN STOP. THE DEVICE WAS PUT INTO AN ULTRASONIC CLEANER TO DISSOLVE THE DRIED BLOOD. THE REMAINING RELEASE WIRE WAS THEN RETRACTED, AND THE COIN RETRACTED FREELY OUT OF THE LUMEN STOP AND DETACHING THE IMPLANT COIL. THE LUMEN STOP WAS FOUND TO BE VISUALLY UNDAMAGED. THE LUMEN STOP INNER DIAMETER (ID) WAS MEASURED TO BE 0.0029¿ AND FOUND TO BE WITHIN SPECIFICATION. THE COIN WAS TO BE 0.083 MM @ 0.063 MM, MEASURED 0.105 MM @ 0.127 MM AND MEASURED 0.107 MM @ 0.275 MM; WHICH IS WITHIN SPECIFICATION. NO OTHER DAMAGES OR ABNORMALITIES WERE OBSERVED. BASED ON THE ANALYSIS PERFORMED, THE CUSTOMER REPORT OF ¿NON-DETACHMENT¿ WAS CONFIRMED AS THE DEVICE WAS RETURNED WITH THE IMPLANT COIL STILL ATTACHED. THERE WERE EVIDENCE OF DETACHMENT ATTEMPTS AT THE ACTUATOR INTERFACE AND POSITIVE LOAD INDICATOR. THE LIKELY CAUSE OF THE NON-DETACHMENT IS THE DRIED BLOOD FOUND WITHIN THE LUMEN STOP. WHEN THE DRIED BLOOD WAS DISSOLVED, THE IMPLANT COIL DETACHED WITH NO ISSUE. THE RELEASE WIRE WAS FOUND BROKEN. IT IS LIKELY THE BREAK ON THE RELEASE WIRE OCCURRED DURING THE ATTEMPT TO RETRACT THE RELEASE WIRE AGAINST THE RESISTANCE CAUSED BY THE COAGULATED BLOOD. AS THE INSTANT DETACHER AND ACTUATOR INTERFACE WERE NOT RETURNED FOR ANALYSIS, ANY CONTRIBUTION OF THE INSTANT DETACHER AND ACTUATOR INTERFACE TOWARDS THE NON-DETACHMENT COULD NOT BE DETERMINED. THE IMPLANT COIL WAS FOUND DAMAGED, INDICATIVE OF ADVANCING AGAINST RESISTANCE OR DAMAGE DURING RETURN SHIPPING AS THE DEVICE WAS RETURNED WITHOUT ITS PROTECTIVE DISPENSER COIL AND INTRODUCER SHEATH. THERE WAS NO NON-CONFORMANCE TO SPECIFICATION IDENTIFIED THAT COULD POTENTIALLY CONTRIBUTE TOWARDS THE NON-DETACHMENT. H6: METHOD CODE UPDATED TO B19. RESULT CODE UPDATED TO C070601 AND C070603. CONCLUSION CODE UPDATED TO D15. 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.
NO ADDITIONAL INFORMATION RECEIVED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE AFTER REMOVAL.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS INSERTED BUT THEN EXPERIENCED NON-DETACHMENT. ABOUT FIVE ATTEMPTS WERE MADE USING THE INSTANT DETACHER (ID), AND IT WAS UNKNOWN IF ANOTHER ID OR MANUAL DETACHMENT METHOD WERE USED. THE ID WAS DISCARDED, AND IT WAS UNKNOWN IF THERE WERE ANY ISSUES WITH THE ID. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127420 | CONCERTO NYLON | DEVICE, EMBOLIZATION, VASCULAR | KRD | MICRO THERAPEUTICS, INC. DBA EV3 | NV-5-20-HELIX | B100353 | 00847536033566 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |