AXIUM PRIME BRPL HLX
Report
- Report Number
- 2029214-2022-00083
- Event Type
- Malfunction
- Date Received
- January 24, 2022
- Date of Event
- January 19, 2022
- Report Date
- April 8, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRD
- UDI-DI
- 00847536032149
- PMA / PMN Number
- K151447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
H3. PRODUCT ANALYSIS:EQUIPMENT USED: VIDEO INSPECTION SYSTEM (M-78210) WITH MICROSCOPE, RULER (M-83361), CAMERA (PANASONIC LUMIX DMC-ZS5) . AS FOUND CONDITION: THE PUSHWIRE WAS RETURNED FOR EVALUATION; INSIDE OF A BIOHAZARD BAG AND A SHIPPING BOX. THERE WAS NO IMPLANT COIL OR INSTANT DETACHER RETURNED WITH THE PUSHWIRE. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE IMPLANT COIL APPEARED TO BE DETACHED FROM THE PUSHWIRE. THE SHIELD COIL FOUND INTACT WITH NO DAMAGE. THE COIN WAS NOT PRESENT AGAINST THE LUMEN STOP AS IT WAS PULLING BACK. THE PUSHER WAS FOUND BROKEN AT THE DISTAL BREAK INDICATOR (MANUAL DETACHMENT LOCATION); IT APPEARED THAT THE MANUAL DETACHMENT WAS ATTEMPTED AT THIS LOCATION. THE AI AND COUPLER TUBING WERE PRESENT AND INTACT; IT APPEARED THAT THE MECHANICAL DETACHMENT WAS NOT ATTEMPTED AT THIS LOCATION. TESTING/ANALYSIS: UNDER THE MICROSCOPE, THE OUTER JACKET WAS THEN REMOVED TO GAIN ACCESS THE COIN. THE COIN WAS MEASURED IN 3 LOCATIONS (0.074MM @ 0.063MM; MEASURED 0.083MM @ 0.127MM; MEASURED 0.095MM @ 0.275MM) AND FOUND TO BE WITHIN SPECIFICATIONS. THE INNER DIAMETER OF THE LUMEN STOP, AND THE INNER DIAMETER OF THE RETAINER RING WERE FOUND TO BE VISUALLY ACCEPTABLE. THE LUMEN STOP INNER DIAMETER (ID) WAS MEASURED TO BE 0.00280¿ AND FOUND TO BE WITHIN SPECIFICATION. THE RETAINER RING INNER DIAMETER (ID) WAS MEASURED TO BE 0.00462 ¿AND FOUND TO BE WITHIN SPECIFICATION. ALL OTHER SUBASSEMBLIES APPEARED TO BE NORMAL, AND NO OTHER ANOMALIES WERE OBSERVED. CONCLUSION: BASED ON THE ANALYSIS PERFORMED, THE AXIUM PRIME COIL WAS NOT CONFIRMED TO HAVE "NON-DETACHMENT" ISSUE AS THE PUSHWIRE WAS RETURNED WITH THE IMPLANT COIL ALREADY DETACHED. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE RETURNED DEVICE, THERE WAS EVIDENCE OF MANUAL DETACHMENT ATTEMPTS TO DETACH THE COIL AS THE PUSHWIRE WAS FOUND BROKEN AT THE MANUAL DETACHMENT LOCATION. THE COIN WAS PULLED BACK FROM THE LUMEN STOP. THE PULLING BACK OF THE COIN FROM THE LUMEN STOP MAY HAVE CONTRIBUTED TO THE DETACHMENT OF THE IMPLANT COIL FROM THE PUSHWIRE. THERE WAS NO NON-CONFORMANCE TO SPECIFICATION IDENTIFIED THAT THAT LED TO THE REPORTED ISSUE. THE REVIEW OF LOT HISTORY RECORDS SHOWS THAT THE FINISHED DEVICE HAS MET ALL MANUFACTURING REQUIREMENTS AND SPECIFICATIONS DURING FINAL ASSEMBLY AND QUALITY INSPECTION. SINCE THE IMPLANT COIL AND INSTANT DETACHER WERE NOT RETURNED; ANY CONTRIBUTION OF THE IMPLANT COIL AND INSTANT DETACHER TO THE NON-DETACHMENT ISSUE COULD NOT BE DETERMINED. H6. CODING UPDATED BASED AN ANALYSIS RESULTS. 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.
MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT COULD NOT BE DETACHED AND ANOTHER AXIUM COIL THAT HAD RESISTANCE AND JUMPING DURING DELIVERY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED AMORPHOUS CAVERNOUS SINUS SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.37MM AND THE NECK DIAMETER WAS 4.27MM. BLOOD FLOW WAS HIGH. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE AXIUM COIL (MODEL: APB-1.5-4-HX-ES, LOT: B170548) COULD NOT BE DETACHED DURING THE FILLING PROCESS. 2 ATTEMPTS WERE MADE WITH ONE INSTANT DETACHER (ID) AND 1 ATTEMPT WAS MADE WITH A SECOND ID WITHOUT SUCCESS; IT WAS NOTED THERE WAS NO ISSUE WITH THE INSTANT DETACHERS. 1 ATTEMPT WAS ALSO MADE AT MANUAL DETACHMENT WITHOUT SUCCESS. THE COIL WAS REMOVED AND REPLACED. DURING THE SAME PROCEDURE, ANOTHER AXIUM COIL (MODEL: QC-4-8-3D, LOT: B201128) FELT VERY HARD DURING THE FILLING PROCESS WITH JUMPING OBSERVED AND THE COIL COULD NOT BE RANDOMLY TURNED IN THE ANEURYSM. IT WAS NOTED THE TIP OF THE CATHETER WAS MOVED DURING DEPLOYMENT. THE PHYSICIAN ROTATED THE PUSHER. THERE WAS CONCERN THAT THE COIL COULD RUPTURE THE ANEURYSM WITH CONTINUED ATTEMPTS SO THE COIL WAS REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICE: ECHELON 10 MICROCATHETER, NAVIEN 6F CATHETER, SYNCHRO2 GUIDEWIRE
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE MANUAL DETACHMENT WAS USED, WITH NO INSTANT DETACHER. THERE WAS RESISTANCE TO RETRACTION OF THE PUSH WIRE. THERE WAS NO PUSHWIRE OR COIL DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1949191 | AXIUM PRIME BRPL HLX | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION | KRD | MICRO THERAPEUTICS, INC. DBA EV3 | APB-1.5-4-HX-ES | B170548 | 00847536032149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |