ONYX AVM
Report
- Report Number
- 2029214-2020-01014
- Event Type
- Injury
- Date Received
- October 11, 2020
- Date of Event
- October 6, 2020
- Report Date
- December 28, 2020
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ANALYSIS FINDINGS: THE ONYX KIT (LOT # A992791) WAS RETURNED FOR EVALUATION INSIDE A SHIPPING BOX. THERE WAS NO CATHETER RETURNED WITH THE ONYX KIT. NO DAMAGES TO THE ONYX KIT PACKAGING. THE ONYX KIT WAS NOT USED. THE RETURNED ONYX KIT CONTAINED A SYRINGE POUCH (LOT # A970884), IFU (LOT # 802582), DMSO VIAL (LOT # A976632) AND ONYX VIAL (LOT # A976615). THESE WERE COMPONENTS THAT WENT INTO AN ONYX KIT. EACH OF THE COMPONENTS HAD ITS OWN LOT NUMBER. THE ONYX KIT WAS THE FINAL PRODUCT AND HAD ITS OWN SEPARATE LOT NUMBER. THE DEVICE HISTORY REVIEW (DHR) WAS PERFORMED ON THE ONYX KIT LOT #A992791 AND ONYX SUB-COMPONENT LOT #A976615. NO LABELING ERROR WAS FOUND. THE RETURNED ONYX VIAL WAS NOT USED. THE ONYX VIAL WAS THEN PLACED ON AN IN-HOUSE ONYX MIXER AND THEN SHOOK FOR 20 MINUTES A SETTING OF 8 PER THE IFU. THE ONYX SOLUTION IN THE VIAL APPEARED TO BE MIXING WELL. AFTER MIXING, THE ONYX SOLUTION WAS THEN ASPIRATED IMMEDIATELY INTO AN IN-HOUSE ONYX 1ML SYRINGE WITH AN 18 GAUGE NEEDLE FOR DENSITY TESTING. THE DENSITY MEASUREMENT FOR LOT: A976615 = 1.70G/ML; WHICH IS WITHIN THE SPECIFICATIONS. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS AND THE REPORTED EVENT DETAILS, THE CUSTOMER'S REPORT OF ¿LABELING ERROR¿, ¿POOR ONYX VISUALIZATION¿ AND ¿PREMATURE SOLIDIFICATION¿ WERE NOT CONFIRMED. THE ONYX VIAL LOT (A976615) DID NOT MATCH WITH THE ONYX KIT LOT (A992791) WAS DUE TO THE ONYX VIAL LOT WAS ONE OF THE COMPONENTS THAT WENT INTO AN ONYX KIT. THE RETURNED ONYX VIAL WAS VISUALLY INSPECTED, MIXED AND THEN TESTED FOR DENSITY; AND FOUND TO BE WITHIN SPECIFICATIONS. THE LOT HISTORY RECORD OF THE TANTALUM POWDER'S LOT NUMBER HAS BEEN REVIEWED AND NO QUALITY ISSUES WERE NOTED. THE VIAL FILL CHECK SHEET RECORD WAS ALSO VERIFIED FOR VIALS WEIGHT AND THE RESULTS ARE WITHIN ACTUAL VOLUME. IN ADDITION, THE REVIEW OF LOT HISTORY RECORDS SHOWS THAT THE FINISHED DEVICE HAS MET ALL MANUFACTURING REQUIREMENTS AND SPECIFICATIONS DURING FINAL ASSEMBLY AND QUALITY INSPECTION. THERE WAS NO NON-CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE REPORTED ISSUE. SINCE THE CATHETER WAS NOT RETURNED; THEREFORE, ANY CONTRIBUTION OF THE CATHETER TO THE ONYX PREMATURE SOLIDIFICATION ISSUE COULD NOT BE DETERMINED. PER OUR INSTRUCTIONS FOR USE (IFU): ¿SHAKE ONYX AT LEAST 20 MINUTES ON AN ONYX MIXER AT A SETTING OF 8. CONTINUE MIXING UNTIL READY TO INJECT. FAILURE TO CONTINUOUSLY MIX ONYX FOR THE REQUIRED TIME MAY RESULT IN INADEQUATE SUSPENSION OF THE TANTALUM, RESULTING IN INADEQUATE FLUOROSCOPIC VISUALIZATION DURING DELIVERY. INJECT ONYX IMMEDIATELY AFTER MIXING. IF ONYX INJECTION IS DELAYED, TANTALUM SETTLING CAN OCCUR WITHIN THE SYRINGE RESULTING IN POOR VISUALIZATION OF ONYX DURING INJECTION. PREMATURE SOLIDIFICATION OF ONYX LES MAY OCCUR IF MICRO CATHETER LUER CONTACTS SALINE, BLOOD OR CONTRAST OF ANY AMOUNT. VERIFY THAT THE CATHETERS AND ACCESSORIES USED IN DIRECT CONTACT WITH THE ONYX LES POLYMER ARE CLEAN AND COMPATIBLE WITH THE MATERIAL AND DO NOT TRIGGER PRECIPITATION OR DEGRADE WITH CONTACT.¿ H6. CODING WAS UPDATED. 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 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 PATIENT WAS CURRENTLY RECOVERING. THERE HAD BEEN NO LONG PAUSES OF OVER 2 MINUTES DURING THE INJECTION. THERE WAS NO RESISTANCE NOTED DURING THE DMSO INJECTION.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONLY 4 OF THE 10 VIALS USED HAD THE PACKAGING ISSUE. THERE HAD BEEN NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE SECOND CATHETER USED WAS AN APOLLO. A CAUSE FOR THE BLEED IN THE VESSEL WAS NOT DETERMINED, THOUGH THE DOCTOR THEORIZED IT MAY HAVE BEEN A VASOSPASM. THE PATIENT WAS RECOVERING FROM THE PROCEDURE. NO ADDITIONAL ADVERSE EVENTS OR ANY MEDICAL/SURGICAL INTERVENTIONS HAVE BEEN PERFORMED TO TREAT THE HEMORRHAGING.
REFER TO MANUFACTURER REPORTS 2029214-2020-01012 AND 2029214-2020-01013 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED A REPORT THAT DURING THE INITIAL EMBOLIZATION, THE DOCTOR COMPLAINED OF THE ONYX NOT FEELING SMOOTH, THE INJECTION WAS COMING IN COLUMNS, BREAKING OFF, AND POOR VISUALIZATION . THE SPEED SETTING ON THE SHAKER WAS 8, AND THE ONYX WAS SHAKEN FOR MORE THAN 20 MINUTES. IT WAS NOTED THE VIALS DID NOT SIT FOR MORE THAN FIVE MINUTES PRIOR TO INJECTION SINCE INJECTION WAS PERFORMED IMMEDIATELY AFTER SHAKING. THE ONYX WAS CHANGED OUT TO CONTINUE EMBOLIZATION. LATER IN THE PROCEDURE, THE DOCTOR DECIDED TO EMBOLIZE A DIFFERENT FEEDER TO THE ARTERIOVENOUS MALFORMATION (AVM), BUT UPON CONNECTING THE SYRINGE, THERE WAS HIGH RESISTANCE DUE TO CATHETER OCCLUSION, AND THE DOCTOR WAS UNABLE TO VISUALIZE THE ONYX AGAIN. INJECTION WAS STOPPED, AND THE CATHETER WAS CHANGED OUT. THE VESSEL WAS RE-CATHETERIZED, AND A DIFFERENT BATCH OF ONYX WAS PREPARED. EMBOLIZATION WENT AS NORMAL, BUT WHEN PULLING THE CATHETER OUT AFTER A FEW MINUTES OF INJECTION, THE PATIENT ENCOUNTERED A BLEED IN THE VESSEL. THE VESSEL WAS ACCESSED AGAIN, AND THE BLEED WAS SUCCESSFULLY ARRESTED. IT WAS UNCLEAR IF THERE WAS ANY ISSUE WITH THE CATHETER OR ONYX. HOWEVER, IT WAS REALIZED THE ONYX VIALS LOT NUMBER WAS A976615 WHILE THE PACKAGING STATED A992791. POST-PROCEDURE EXPERT COMPUTERIZED TOMOGRAPHY (CT) IMAGING SHOWED THE PATIENT HAD A SMALL SUBDURAL AND SUBARACHNOID BLEEDING. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION (AVM) IN THE ELOQUENT REGION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1124799 | ONYX AVM | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | 105-7000-060 | A992791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |