SOLITAIRE FR
Report
- Report Number
- 2029214-2024-00638
- Event Type
- Malfunction
- Date Received
- April 11, 2024
- Date of Event
- April 8, 2024
- Report Date
- June 28, 2024
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- NRY
- PMA / PMN Number
- K113455
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT ANALYSIS #(B)(4):¿ EQUIPMENT USED: VIS (M-78210), 203CM RULER (M-83361) ¿ AS FOUND CONDITION: THE SOLITAIRE FR REVASCULARIZATION DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, A PLASTIC POUCH, AND AN OPENED SOLITAIRE FR INNER POUCH (B508978). ¿ DAMAGE LOCATION DETAILS: THE SOLITAIRE FR REVASCULARIZATION DEVICE WAS RETURNED WITHIN ITS INTRODUCER SHEATH. NO DAMAGES WERE FOUND WITH THE INTRODUCER SHEATH. NO BENDS OR KINKS WERE FOUND WITH THE PUSHER. THE STENT WAS FOUND STILL ATTACHED TO THE PUSHER. THE STENT¿S NON-WORKING LENGTH STRUTS WERE FOUND BENT AND A STRUT WAS FOUND BROKEN. THE STENT¿S REMAINING WORKING LENGTH STRUTS WERE FOUND TO BE IN GOOD CONDITION. ¿ TESTING/ANALYSIS: THE SOLITAIRE FR REVASCULARIZATION DEVICE COULD NOT BE PUSHED OUT FROM WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS PULLED OUT PROXIMALLY. THE BROKEN STENT WAS SENT OUT FOR SEM FAILURE ANALYSIS. PER THE SEM REPORT, THE BROKEN END FAILED VIA FATIGUE AT THE SURFACE, THEN TO OVERLOAD. ¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿RESISTANCE¿ AND ¿SEPARATION¿ REPORTS WERE CONFIRMED. DAMAGE TO THE SOLITAIRE FR STENT (BENT/BROKEN) CAN OCCUR IF ADVANCED/RETRIEVED AGAINST RESISTANCE. POSSIBLE CAUSES OF ¿RESISTANCE DURING DELIVERY¿ INCLUDE THE USE OF AN INCOMPATIBLE CATHETER, CATHETER DAMAGE, PATIENT VESSEL TORTUOSITY, OR FAILURE TO MAINTAIN A CONTINUOUS FLUSH. IN THIS EVENT, IT IS LIKELY THE USE OF AN INCOMPATIBLE CATHETER CONTRIBUTED TO THE REPORTED RESISTANCE. THE REBAR-18 CATHETER HAS A LABELED INNER DIAMETER (ID) OF 0.021¿. AS PER THE SOLITAIRE FR INSTRUCTIONS FOR USE (IFU), ¿SOLITAIRE¿ FR REVASCULARIZATION DEVICE WITH THE SFR-6-20 AND SFR-6-30 REFERENCE NUMBERS SHOULD BE INTRODUCED ONLY THROUGH A MICROCATHETER WITH A MINIMUM INSIDE DIAMETER OF 0.027 INCHES.¿ MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC RECEIVED A REPORT THAT THE HEALTHCARE PROVIDER (HCP) USED THE 8F GAIDIAN (BOSTON SCIENTIFIC CORPORATION), AND ZHONGTIAN DISTAL ACCESS CATHETER (6F 125CM) AS PROXIMAL SUPPORT. THE REBAR-18 MICROCATHETER WAS GUIDED BY THE GUIDEWIRE TO THE LOCATION OF THE INNER CERVICAL LESION. DURING THE THROMBECTOMY PROCESS, WHEN THE INTRACRANIAL THROMBECTOMY STENT (SFR-6-30) WAS INSERTED INTO THE REBAR-18 MICROCATHETER, RESISTANCE WAS FOUND IN THE STENT DURING RETRIEVAL. AFTER BEING WITHDRAWN, IT WAS FOUND THAT THE PROXIMAL END OF THE STENT WAS BROKEN, MAKING IT IMPOSSIBLE TO PUSH IT INTO PLACE AGAIN. THE DAMAGE WAS LOCATED ON THE CONNECTION OF THE PUSH ROD. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ISCHEMIC STROKE. IT WAS NOTED THE PATIENT'S BLOOD VESSEL TORTUOSITY WAS MINIMAL. STROKE ONSET TO REPERFUSION TIME WAS 40 MINUTES.
ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED, BUT IT MIGHT BE RELATED TO THE FORCE USED IN PULLING OUT THE THROMBUS. THE RESISTANCE WAS LOCATED IN THE PROXIMAL SECTION OF THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1446099 | SOLITAIRE FR | CATHETER, THROMBUS RETRIEVER | NRY | MICRO THERAPEUTICS, INC. DBA EV3 | SFR-6-30 | B508978 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female |