CONCERTO VERSA¿
Report
- Report Number
- 2029214-2021-01065
- Event Type
- Malfunction
- Date Received
- August 25, 2021
- Date of Event
- August 19, 2021
- Report Date
- November 8, 2021
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- PUU
- UDI-DI
- 00763000321864
- PMA / PMN Number
- K202850
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
BOTH COILS WERE RETURNED FOR ANALYSIS THOUGH THE COMPLAINT ALLEGATION WAS ONLY REPORTED FOR ONE COIL. H3. PRODUCT ANALYSIS: TWO CONCERTO VERSA PUSHERS (A AND B) WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN INDIVIDUAL OPENED CONCERTO VERSA OUTER CARTONS; WITHIN INDIVIDUAL OPENED CONCERTO VERSA INNER POUCHES AND WITHIN INDIVIDUAL DISPENSER COILS. THE TWO DETACHED IMPLANT COILS (LABELED PART 1 AND PART 2) WERE RETURNED SEPARATELY WITHIN A RESEALABLE PLASTIC POUCH; WITHIN INDIVIDUAL RESEALABLE PLASTIC POUCHES AND WITHIN INDIVIDUAL GLASS VIALS. IT IS NOT POSSIBLE TO DETERMINE WHICH COIL BELONGED TO WHICH PUSHER. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: (A) THE ACTUATOR INTERFACE WAS FOUND TO BE FULLY RETRACTED AND STILL ATTACHED TO THE COUPLER TUBE. THERE IS AN INDICATION THAT A DETACHMENT WAS ATTEMPTED AT THIS LOCATION USING AN INSTANT DETACHER. THE BREAK INDICATOR WAS FOUND INTACT. THERE WERE NO EVIDENCE OF MANUAL DETACHMENT ATTEMPTS AT THIS LOCATION. THE CONCERTO VERSA PUSHER WAS FOUND TO BE INTACT AND UNDAMAGED. THE COIN WAS FOUND PRESENT AND UNDAMAGED. THE COIN WAS FULLY RETRACTED OUT OF THE LUMEN STOP. THE IMPLANT COIL WAS ALREADY DETACHED. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE RETAINER RING (B) THE CONCERTO PUSHER WAS FOUND BROKEN DISTAL TO THE BREAK INDICATOR WITH THE RELEASE WIRE ALSO BROKEN. THE PROXIMAL SEGMENT (ACTUATOR INTERFACE, POSITIVE LOAD INDICATOR, BREAK INDICATOR, AND COUPLER TUBE) WERE NOT RETURNED FOR ANALYSIS. THIS IS INDICATIVE THAT A POTENTIAL MANUAL DETACHMENT WAS ATTEMPTED AT THIS LOCATION. NO OTHER DAMAGES WERE FOUND WITH THE CONCERTO VERSA PUSHER. THE COIN WAS FOUND UNDAMAGED. THE COIN AND RELEASE WIRE WERE FOUND RETRACTED OUT OF THE LUMEN STOP. THE IMPLANT COIL WAS ALREADY DETACHED. THE RETAINER RING WAS FOUND DAMAGED. (PART 1 & 2) BOTH CONCERTO VERSA IMPLANT COILS WERE FOUND DAMAGED, STRETCHED AND BROKEN WITH THE POLYPROPYLENE FILAMENTS ALSO BROKEN. THE DETACH ELEMENT WERE ALREADY SEPARATED FROM THE IMPLANT COIL AND COULD NOT BE LOCATED AND PRESUMED LOST. CONCLUSION: BASED ON THE CUSTOMER REPORT AND DEVICE ANALYSIS, THE CUSTOMER REPORT OF "NON-DETACHMENT" COULD NOT BE CONFIRMED FOR BOTH COILS. IN BOTH DEVICES THE COIN WAS RETRACTED OUT OF THE LUMEN STOP, DETACHING THE IMPLANT COIL AS EXPECTED BY THE DETACHMENT ELEMENTS. PUSHER A HAS EVIDENCE OF DETACHMENT ATTEMPTS USING AN INSTANT DETACHER AND PUSHER B HAS EVIDENCE OF DETACHMENT ATTEMPT BY MANUAL METHOD. HOWEVER, AS THE RELEASE WIRE WAS FOUND BROKEN ON PUSHER B, IT IS POSSIBLE THAT THE NON-DETACHMENT OCCURRED DUE TO THE RELEASE WIRE NOT RETRACTING PROPERLY DURING DETACHMENT ATTEMPT, ALTHOUGH THIS CANNOT BE CONFIRMED THROUGH DEVICE ANALYSIS. THE IMPLANT COILS AND THE SECOND RETAINER RING WERE FOUND DAMAGED/STRETCHED/BROKEN. POSSIBLE CAUSES INCLUDE, BUT NOT LIMITED TO, LACK OF HYDRATION BEFORE PROCEDURE, CONTINUOUS FLUSH NOT PERFORMED DURING PROCEDURE (OR INSUFFICIENT CONTINUOUS FLUSH), TORTUOUS ¿ANATOMY¿, COIL IS NOT RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING, PUSHWIRE ROTATION, USER ADVANCES/RETRACTS THE COIL AGAINST RESISTANCE OR INCOMPATIBLE CATHETER. THE DAMAGED RETAINER RING COLD HAVE CAUSED THE SECOND CONCERTO VERSA TO DETACH FOLLOWING THE REPORTED NON-DETACHMENT. THE INSTANT DETACHER USED IN THE EVENT WAS NOT RETURNED. THEREFORE, ANY CONTRIBUTION OF THE INSTANT DETACHER TOWARDS THE NON-DETACHMENT AND CONFORMANCE TO SPECIFICATION COULD NOT BE ASSESSED. THERE IS NO INDICATION THAT THE EVENT IS RELATED TO A POTENTIAL MANUFACTURING ISSUE. 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 REPORTED THAT THE ANEURYSM MODEL WAS GLASS RATHER THAN SILICONE AS PREVIOUSLY STATED. THE COIL ALSO DETACHED IMMEDIATELY UPON THE SECOND ATTEMPT TO BREAK THE HYPOTUBE, SO IT WAS ONLY RETRACTED UNSUCCESSFULLY TWICE RATHER THAN 3 TIMES.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL DID NOT DETACH. THIS MALFUNCTION OCCURRED DURING A PHYSICIAN USABILITY STUDY WITH A SILICONE MODEL UNDER FLUOROSCOPY. PHYSICIAN DEPLOYED COIL INTO A SILICONE MODEL OF AN ANEURYSM, INTO WHICH A 16X65 VERSA HAD ALREADY BEEN DEPLOYED (THUS LEADING TO A DENSE COIL MASS). PER THE PROTOCOL OF THE USABILITY STUDY, THE MEDTRONIC TEAM ASKED THE PHYSICIAN TO MANUALLY DETACH THIS COIL. PHYSICIAN BROKE THE PUSHER AT THE EDGE OF THE BLACK HEAT SHRINK (HBI), AND THE COIL DID NOT DETACH (SHE PULLED BACK ON THE PUSHER AND THE COIL MOVED AND WITHDREW SEVERAL CENTIMETERS INTO THE CATHETER). THE TEAM ASKED HER TO PULL THE TWO PORTIONS OF THE PUSHER APART 1-2CENTIMETERS AND TRY AGAIN. SHE DID THIS, AND THE RELEASE WIRE BROKE; THE COIL WAS STILL ATTACHED TO THE PUSHER (SHE MOVED THE PUSHER AND THE COIL MOVED AS WELL). MEDTRONIC PERSONNEL ASKED HER TO BREAK THE PUSHER AGAIN 1 CM MORE DISTALLY (ON THE BLACK HEAT SHRINK) AND PULL THOSE PIECES APART. SHE DID, AND SHE ATTEMPTED TO RETRACT AGAIN; AGAIN, THE COIL WAS WITHDRAWN WITH THE PUSHER SEVERAL CENTIMETERS INTO THE CATHETER. SHE ADVANCED THE SYSTEM BACK INTO THE ANEURYSM, AND MEDTRONIC PERSONNEL ASKED HER TO PULL THE WHOLE SYSTEM OUT. SHE BEGAN WITHDRAWING, AND DURING THE WITHDRAWAL, THE COIL DID DETACH. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. 3 PULLS. NO INSTANT DETACHER USED WITH THIS COIL PER REQUEST OF MEDTRONIC PERSONNEL. THE DEVICES WERE NOT PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). DEVIATIONS: NO CONTINUOUS FLUSH, NO RHV USED, PUSHER MAY HAVE BEEN EXTENDED BEYOND CATHETER TIP INTO DENSE COIL MASS. THERE IS NO PATIENT INVOLVED IN THIS EVENT ANCILLARY DEVICES: TERUMO DESTINATION 6F RSC01 ST-TBV LOT QF22 SHEATH, TERUMO 4F GLIDECATH STRAIGHT TIP REF: (B)(4), LOT: 190128 GUIDECATHETER, BOSTON SCIENTIFIC RENEGADE HI FLO (.027" ID) REF: (B)(4), LOT: 25376428 MICROCATHETER, TERUMO ANGLED TIP GLIDEWIRE (0.03 5") REF: (B)(4), LOT 170310, GUIDEWIRE THIS WIRE WAS USED TO ACCESS SITE BUT WAS NO LONGER IN USE AT THE TIM:E OF THE DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1266066 | CONCERTO VERSA¿ | TEMPORARY COIL EMBOLIZATION ASSIST DEVICE | PUU | MICRO THERAPEUTICS, INC. DBA EV3 | CV-18-65 | B172131 | 00763000321864 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |