FRED 27
Report
- Report Number
- 2032493-2023-00929
- Event Type
- Injury
- Date Received
- September 7, 2023
- Date of Event
- July 25, 2023
- Report Date
- August 21, 2023
- Manufacturer
- MICROVENTION, INC.
- Product Code
- OUT
- UDI-DI
- 00842429117170
- PMA / PMN Number
- P180027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION FINDINGS ITEMS RETURNED: - N/A. VISUAL ANALYSIS: A VISUAL INSPECTION OF THE DEVICE CAPTURED IN THIS FILE COULD NOT BE PERFORMED AS A PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION, NOR WERE ANY IMAGES OF THE DEVICE PROVIDED IN PLACE OF A DEVICE RETURN. PROCEDURE AND MEDICAL IMAGING WAS NOT PROVIDED FOR THIS INVESTIGATION. INVESTIGATION FINDINGS: WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT DEFINITIVELY DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION DEFINITIVELY DETERMINE THE CAUSE OF THE REPORTED EVENT. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE ANY POTENTIAL OR NEW MANUFACTURING, DESIGN, QUALITY, OR OTHER SYSTEMIC ISSUES, OR NON-CONFORMANCES. THE COMPLAINT CODE IS MONITORED THROUGH THE TRENDING PROCESS; CORRECTIVE ACTION IS DETERMINED, AS NEEDED, THROUGH THIS PROCESS. INVESTIGATIONS OF HISTORIC COMPLAINT FILES WITH SIMILAR COMPLAINT CATEGORY CODING ARE RECORDED IN THE COMPLAINT HANDLING SYSTEM; WITHOUT THE ABILITY TO PERFORM AND ANALYSIS OF THE DEVICE, THIS INVESTIGATION CANNOT IDENTIFY WITH CERTAINTY ANY POTENTIAL ROOT CAUSES. BATCH REVIEW: A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. COMPLAINT SYSTEM REVIEW: LISTED BELOW ARE THE COMPLAINTS FROM THE LAST 2 YEARS RECORDED IN THE COMPLAINT HANDLING SYSTEM WITH THIS BATCH NUMBER AT THE TIME OF THIS INVESTIGATION: P23-4364, P23-4002. BASED ON A REVIEW OF THE LAST 2 YEARS OF COMPLAINT DATA, AND AT THE TIME OF THIS INVESTIGATION, NO SYSTEMIC ISSUES HAVE BEEN IDENTIFIED FOR THIS BATCH NUMBER THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): POTENTIAL COMPLICATIONS: POSSIBLE COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: ¿ BLEEDING OR HEMORRHAGE INCLUDING INTRACEREBRAL, RETROPERITONEAL OR OTHER LOCATIONS. ¿ COMPLICATIONS OF ARTERIAL PUNCTURE INCLUDING PAIN, LOCAL BLEEDING (HEMATOMA) OR INJURY TO THE ARTERY OR ADJACENT NERVES. ¿ DEVICE MIGRATION. ¿ DISTAL EMBOLIZATION. ¿ HEADACHE. ¿ INCOMPLETE ANEURYSM OCCLUSION. ¿ NEUROLOGIC DEFICITS INCLUDING STROKE AND/OR DEATH. ¿ PERFORATION OR DISSECTION OF THE VESSEL(S). ¿ PSEUDOANEURYSM FORMATION. ¿ RUPTURE OR PERFORATION OF ANEURYSM. ¿ TRANSIENT ISCHEMIC ATTACK (TIA) OR ISCHEMIC STROKE. ¿ VASOSPASM. ¿ VESSEL OCCLUSION. ¿ VESSEL STENOSIS OR THROMBOSIS. WARNINGS: THE FRED 27-SYSTEM SHOULD ONLY BE DELIVERED THROUGH A HEADWAY 27 MICROCATHETER AND THE FRED 21-SYSTEM SHOULD ONLY BE DELIVERED THROUGH A HEADWAY 21 MICROCATHETER. IF REPEATED FRICTION IS ENCOUNTERED DURING FRED SYSTEM DELIVERY, VERIFY MICROCATHETER IS NOT KINKED OR IN EXTREMELY TORTUOUS ANATOMY. CONFIRM THAT THE MICROCATHETER DOES NOT OVALIZE. CONFIRM THAT THERE IS ADEQUATE STERILE HEPARINIZED FLUSH SOLUTION. DO NOT REPOSITION THE FRED SYSTEM IN THE PARENT VESSEL WITHOUT FULLY RETRIEVING THE DEVICE. THE FRED SYSTEM MUST BE RETRIEVED/RESHEATHED INTO THE MICROCATHETER AND RE-DEPLOYED AT THE DESIRED TARGET LOCATION OR REMOVED COMPLETELY FROM THE PATIENT. THE FRED SYSTEM MUST NOT BE RE-DEPLOYED MORE THAN THREE TIMES. SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING ACCESS OR REMOVAL, THE INTRODUCER/GUIDE CATHETER/MICROCATHETER AND FRED SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE DURING DELIVERY OR RETRIEVAL OF THE FRED SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE DEVICE AND DELIVERY COMPONENTS. THE FRED SYSTEM DELIVERY WIRE SHOULD NOT BE UTILIZED AS A GUIDEWIRE. DO NOT TORQUE THE FRED SYSTEM. A TORQUE DEVICE SHOULD NOT BE USED. DIRECTIONS FOR USE: 17. ADVANCE THE DELIVERY WIRE TO TRANSFER THE FRED SYSTEM FROM WITHIN THE INTRODUCER INTO THE MICROCATHETER. 18. WARNING: DO NOT TORQUE THE DELIVERY WIRE WHILE ADVANCING OR RETRACTING THE FRED SYSTEM. 21. WARNING: DO NOT APPLY UNDUE FORCE. IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING DELIVERY OR MANIPULATION, WITHDRAW THE UNIT AND SELECT A NEW FRED SYSTEM. 23. POSITION THE FRED SYSTEM FOR DEPLOYMENT BY ALIGNING THE FRED SYSTEM IMPLANT DISTAL RADIOPAQUE END MARKERS PAST THE ANEURYSM NECK, ALLOWING FOR ADEQUATE DISTAL AND PROXIMAL DEVICE LANDING ZONES AS SHOWN IN THE FOLLOWING FIGURES FOR FRED-27 SYSTEM AND FRED-21 SYSTEM. 26. NOTE: A SLOW, PROPER PUSH/PULL TECHNIQUE, ENCOMPASSING SUFFICIENT DELIVERY WIRE PUSH FORCE, IN ADDITION TO AN OPPOSING MICROCATHETER WITHDRAWAL FORCE, TO REMOVE EXCESS MICROCATHETER SLACK WHILE MAINTAINING THE MICROCATHETER TIP WITHIN THE CENTER OF THE PARENT VESSEL, WILL FACILITATE PROPERLY DEPLOYING THE FRED SYSTEM AT THE PROPER LOCATION, TO ACHIEVE FULL EXPANSION AND GOOD VESSEL APPOSITION.
A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL MDR REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES THROMBUS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.
IT WAS REPORTED THAT A RIGHT C4 UNRUPTURED, SACCULAR ANEURYSM WAS TREATED, THE STENT WAS SUCCESSFULLY IMPLANTED. IMMEDIATE POSTOPERATIVE IMAGING RESULTS REVEALED THE STENT FULLY COVERING THE ANEURYSM NECK, WITH GOOD WALL APPOSITION, PARENT ARTERY PERFUSION, RETENTION OF CONTRAST MEDIA. THROMBOSIS OCCURRED IN THE A1 SEGMENT DURING THE OPERATION, WHICH WAS SUSPECTED TO BE CAUSED BY THE HEAD END OF GUIDE WIRE OF THE FRED. THE PATIENT WAS RELIEVED AFTER THROMBOLYSIS.
IT WAS REPORTED THAT A RIGHT C4 UNRUPTURED, SACCULAR ANEURYSM WAS TREATED, THE STENT WAS SUCCESSFULLY IMPLANTED. IMMEDIATE POSTOPERATIVE IMAGING RESULTS REVEALED THE STENT FULLY COVERING THE ANEURYSM NECK, WITH GOOD WALL APPOSITION, PARENT ARTERY PERFUSION, RETENTION OF CONTRAST MEDIA. THROMBOSIS OCCURRED IN THE A1 SEGMENT DURING THE OPERATION, WHICH WAS SUSPECTED TO BE CAUSED BY THE HEAD END OF GUIDE WIRE OF THE FRED. THE PATIENT WAS RELIEVED AFTER THROMBOLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1105579 | FRED 27 | INTRALUMINAL DEVICES | OUT | MICROVENTION, INC. | FRED5029-CN | 0000347911 | 00842429117170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention |