FRED X27
Report
- Report Number
- 2032493-2024-00217
- Event Type
- Death
- Date Received
- March 13, 2024
- Date of Event
- February 23, 2024
- Report Date
- March 28, 2024
- Manufacturer
- MICROVENTION, INC.
- Product Code
- OUT
- UDI-DI
- 00842429114360
- PMA / PMN Number
- P180027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED 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 IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS AND INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES VESSEL STENOSIS OR THROMBOSIS, NEUROLOGIC DEFICITS INCLUDING STROKE AND/OR DEATH AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.
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. 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. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THE PRESENCE OF 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: THERE ARE NO SIMILAR COMPLAINTS BASED ON THE COMPLAINT CATEGORY REGARDING THIS BATCH NUMBER FROM THE LAST TWO YEARS RECORDED IN THE COMPLAINT SYSTEM AT THE TIME OF THIS INVESTIGATION. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): POTENTIAL COMPLICATIONS BELOW IS A LIST OF THE PROBABLE ADVERSE EFFECTS (E.G., COMPLICATIONS) ASSOCIATED WITH THE USE OF NEUROVASCULAR FLOW DIVERTING STENTS. ¿ ALLERGIC REACTION, INCLUDING BUT NOT LIMITED TO: CONTRAST DYE, NITINOL METAL, AND ANY OTHER MEDICATIONS USED DURING THE PROCEDURE. AMAUROSIS FUGAX OR TRANSIENT BLINDNESS. APHASIA. BLINDNESS. CARDIAC ARRHYTHMIA. COMPLICATIONS OF ARTERIAL PUNCTURE INCLUDING PAIN, LOCAL BLEEDING, OR INJURY TO THE ARTERY, OR ADJACENT NERVES. CRANIAL NEUROPATHY. DEATH. DEVICE FRACTURE, MIGRATION OR MISPLACEMENT. DIPLOPIA. DISSECTION OR PERFORATION OF THE PARENT ARTERY. HEADACHE. HEMIPLEGIA. HEMORRHAGE, INCLUDING INTRACRANIAL HEMORRHAGE (ICH), SUBARACHNOID HEMORRHAGE (SAH), AND RETROPERITONEAL. HYDROCEPHALUS. INFECTION. MASS EFFECT. MYOCARDIAL INFARCTION. NEUROLOGICAL DEFICITS. PSEUDOANEURYSM FORMATION. REACTIONS TO ANTI-PLATELET OR ANTI-COAGULANT AGENTS. REACTIONS DUE TO RADIATION EXPOSURE, INCLUDING ALOPECIA, BURNS RANGING IN SEVERITY FROM SKIN REDDENING TO ULCERS, CATARACTS, AND DELAYED NEOPLASIA. REACTIONS TO ANESTHESIA AND RELATED PROCEDURES. REACTIONS TO CONTRAST AGENTS INCLUDING ALLERGIC REACTIONS AND KIDNEY FAILURE. REDUCED VISUAL ACUITY OR VISUAL FIELD. RETINAL ARTERY OCCLUSION OR INFARCTION. RETINAL ISCHEMIA. RUPTURE OR PERFORATION OF THE ANEURYSM. STENOSIS OF STENTED SEGMENT. SEIZURE. STENT THROMBOSIS. STROKE OR TIA (TRANSIENT ISCHEMIC ATTACK). THROMBOEMBOLIC EVENT. VASOSPASM. VISUAL IMPAIRMENT. 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/RE-SHEATHED 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. 27. CAUTION: USING A RAPID MICROCATHETER WITHDRAWAL TECHNIQUE TO DEPLOY THE FRED SYSTEM IS NOT RECOMMENDED AND MAY RESULT IN DEVICE ELONGATION OR IMPROPER DEPLOYMENT. BE AWARE OF DELIVERY WIRE TIP POSITION DURING DEPLOYMENT. 28. IF THE FRED SYSTEM POSITIONING IS NOT SATISFACTORY, THE IMPLANT MAY BE RECAPTURED AND REPOSITIONED IF IT IS NOT FULLY DEPLOYED. THE IMPLANT MAY BE RECAPTURED UNTIL THE POINT WHERE THE DISTAL-MOST WIRE MARKER, COLLOCATED DISTAL TO THE IMPLANT PROXIMAL MARKERS, IS ALIGNED APPROXIMATELY 50% OF LENGTH PROXIMAL TO THE MICROCATHETER DISTAL MARKER BAND. 29. CAUTION: IF RESISTANCE IS FELT WHILE RECAPTURING THE DEVICE, DO NOT CONTINUE TO RECAPTURE. WITHDRAW THE MICROCATHETER SLIGHTLY TO UNSHEATH THE DEVICE (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE AGAIN. 30. CAUTION: THE FRED SYSTEM MUST NOT BE RE-DEPLOYED MORE THAN THREE TIMES. 31. IF FRED SYSTEM POSITIONING IS SATISFACTORY, CAREFULLY ADVANCE THE DELIVERY WIRE WHILE RETRACTING THE MICROCATHETER AS NEEDED TO MINIMIZE SLACK, MAINTAINING THE MICROCATHETER AROUND THE CENTER OF THE PARENT VESSEL, TO ALLOW THE IMPLANT TO DEPLOY ACROSS THE NECK OF THE ANEURYSM. ENSURE THE IMPLANT PROXIMAL RADIOPAQUE END MARKERS ARE IN THE ADVISED POSITION (SEE STEP 23) PROXIMAL TO THE ANEURYSM NECK FOR ADEQUATE COVERAGE. 32. NOTE: THE FRED SYSTEM WILL EXPAND AND MAY FORESHORTEN UP TO 60% FROM ITS UNDEPLOYED LENGTH. VISUALLY VERIFY OPENING OF THE PROXIMAL END, ENSURING THAT THE MICROCATHETER DISTAL TIP MARKER IS PULLED BACK, ADEQUATELY AWAY FROM THE IMPLANT PROXIMAL END, TO ALLOW THE PROXIMAL END TO FREELY OPEN. PUSH FORWARD ON THE DELIVERY WIRE TO ASSIST IN MAINTAINING ACCESS WITHIN THE IMPLANT AS NEEDED. 33. NOTE: VISUALIZE AND REFER TO IMPLANT RADIOPAQUE END MARKERS TO MAINTAIN ADEQUATE IMPLANT LENGTH ON EACH SIDE OF THE ANEURYSM NECK/TARGET LOCATION TO ENSURE APPROPRIATE COVERAGE. 34. WARNING: DO NOT FULLY DEPLOY THE FRED SYSTEM IF POSITIONING IN THE PARENT VESSEL IS NOT SATISFACTORY. 37. CAREFULLY INSPECT THE DEPLOYED FRED IMPLANT UNDER FLUOROSCOPY TO CONFIRM THAT IT IS COMPLETELY OPEN AND OPPOSED TO THE VESSEL WALL AND NOT KINKED. IF THE IMPLANT IS NOT FULLY OPEN AND APPOSED OR IS KINKED, CONSIDER UTILIZING A SUITABLE MICRO GUIDEWIRE AND/OR OCCLUSION BALLOON CATHETER TO FULLY OPEN THE IMPLANT. 38. CAUTION: CAREFULLY WATCH THE FRED IMPLANT DISTAL AND PROXIMAL MARKERS WHEN PASSING THROUGH THE IMPLANTED DEVICE WITH OTHER DEVICES TO AVOID DISPLACING THE IMPLANT.¿ PROCEDURE/MEDICAL INFORMATION REVIEW: MEDICAL OPERATIVE PROCEDURE NOTE REVIEW, P24-1171, BY FRANK TURNER, D.P.M., DATED MARCH 15, 2024: ¿A DETAILED OPERATIVE PROCEDURE NOTE MEDICAL REVIEW DATED FEBRUARY 19, 2024, WAS PERFORMED ON (B)(6), 2024. AS PART OF THE (B)(6) CLINICAL STUDY, AN EMBOLIZATION PERFORMED UTILIZING FRED X 4.0 X 23/17 IMPLANTABLE DEVICE. INDEX PROCEDURE WAS PERFORMED ON (B)(6), 2024, AND THE EVENT OF THE FRED X DEVICE ASSOCIATED WITH SOME DIFFICULTY OF THE STENT OPENING AROUND THE CAVERNOUS GENUINE OCCURRED DURING THE PERFORMANCE OF THE PROCEDURE ((B)(6) 2024). DATA REVIEW INDICATES THAT THE STENT WAS PARTIALLY RECAPTURED AND THEN REDEPLOYED. A REPEAT SINGLE RUN FRAME IMAGE DEMONSTRATED THAT THE STENT WAS NOW MORE OPPOSED AND OPEN AND ALSO DEMONSTRATED PATENCY OF THE STENT. A DILUTED 3-D ANGIOGRAM WAS OBTAINED WHICH DEMONSTRATED THAT BOTH THE PROXIMAL AND DISTAL ENDS OF THE STENT WERE WELL OPPOSED. DATA REVIEW INDICATES THAT BOTH PROXIMAL AND DISTAL ENDS OF THE STENT ARE OPEN WITHOUT EVIDENCE OF IN-STENT STENOSIS. REVIEW OF DATA FURTHER INDICATES THAT A FINAL AP AND LATERAL CRANIAL VIEWS DID NOT DEMONSTRATE ANY EVIDENCE OF DISTAL EMBOLI. AP AND LATERAL CRANIAL VIEWS DEMONSTRATE THAT THE IDENTIFIED STENT KINK HAS BEEN RESOLVED AND THE STENT DEMONSTRATE THAT IT WAS WELL APPOSED. BASED ON THE REVIEW, AND IN MY MEDICAL OPINION, AN INTRAOPERATIVE IN-STENT OCCLUSION OCCURRED, STROKE WITH ASSOCIATED RIGHT-SIDE WEAKNESS, FACIAL DROP AND APHASIA WHICH WAS TREATED WITH TENECTEPLASE (TNK). REVASCULARIZATION WAS ATTEMPTED BUT WAS REPORTED AS UNSUCCESSFUL. THE REPORTED INTRAOPERATIVE IN-STENT OCCLUSION WHICH OCCURRED AND THE RELATIONSHIP TO THE STUDY DEVICE FRED X STENT CANNOT BE RULED OUT WITH POSSIBLE RELATIONSHIP TO THE STUDY DISEASE.¿ CONCLUSION: AN OPERATIVE PROCEDURE NOTE MEDICAL REVIEW WAS PERFORMED. AS PART OF THE (B)(6) CLINICAL STUDY, AN EMBOLIZATION WAS PERFORMED UTILIZING THE FRED X 4.0 X 23/17 IMPLANTABLE DEVICE. INDEX PROCEDURE WAS PERFORMED ON (B)(6), 2024, AND THE EVENT OF THE FRED X DEVICE ASSOCIATED WITH SOME REPORTED DIFFICULTY OF THE STENT OPENING AROUND THE CAVERNOUS GENUINE OCCURRED DURING THE PERFORMANCE OF THE PROCEDURE ((B)(6), 2024). THE STENT WAS REPORTEDLY PARTIALLY RECAPTURED AND THEN REDEPLOYED. A REPEAT SINGLE RUN FRAME IMAGE DEMONSTRATED THAT THE STENT WAS NOW MORE OPPOSED AND OPEN AND DEMONSTRATED PATENCY OF THE STENT. A DILUTED 3-D ANGIOGRAM WAS OBTAINED WHICH DEMONSTRATED THAT BOTH THE PROXIMAL AND DISTAL ENDS OF THE STENT WERE WELL OPPOSED. BOTH PROXIMAL AND DISTAL ENDS OF THE STENT WERE OPEN WITHOUT EVIDENCE OF IN-STENT STENOSIS. A FINAL AP AND LATERAL CRANIAL VIEWS DID NOT DEMONSTRATE ANY EVIDENCE OF DISTAL EMBOLI. AP AND LATERAL CRANIAL VIEWS DEMONSTRATE THAT THE IDENTIFIED STENT KINK HAD BEEN RESOLVED AND THE STENT DEMONSTRATES THAT IT WAS WELL APPOSED. BASED ON THE REVIEW OF THE DATA, THE REPORTED INTRAOPERATIVE IN-STENT OCCLUSION AND ITS RELATIONSHIP TO THE STUDY DEVICE FRED X STENT CANNOT BE RULED OUT. HOWEVER, 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. MANUFACTURER DISCLAIMER TO BE ADDED TO THE MANUFACTURER NARRATIVE PORTION OF THE FORM: MICROVENTION 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 MICROVENTION, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MICROVENTION 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, MICROVENTION, OR ITS EMPLOYEES THAT THE DEVICE, MICROVENTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. 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.
AS COMMUNICATED THROUGH THE FREDX PAS CLINICAL STUDY TECHNICAL EVENT REPORT, THE PATIENT SUFFERED AN IN-STENT OCCLUSION (AE1) ON POD 5 AND WAS GIVEN TNK BUT THEN HAD A CONTRALATERAL HEMORRHAGE (AE2). SHE WAS BROUGHT TO ANGIO TO TRY TO OPEN THE STENT WHICH WAS UNSUCCESSFUL, AND THE CONTRALATERAL HEMORRHAGE SIGNIFICANTLY INCREASED SO THE FAMILY ELECTED NOT TO PURSUE FURTHER INTERVENTION. THE PATIENT DETAILS, PROCEDURE DETAILS AND AE DETAILS ARE PENDING SITE ENTRY ON THE ELECTRONIC DATA CAPTURE SYSTEM. THE CONTRALATERAL HEMORRHAGE (AE2) WAS INDICATED AS NOT RELATED TO THE STUDY DEVICE, BUT PROBABLY RELATED TO THE INDEX PROCEDURE. ADDITIONAL INFORMATION INDICATED, EVENT: STENT OCCLUSION/STROKE. ¿PATIENT PRESENTED TO THE ED AS A TRANSFER FROM OUTSIDE HOSPITAL WITH ACUTE ONSET RIGHT-SIDED WEAKNESS, FACIAL DROOP, AND APHASIA. PATIENT GIVEN TNK AT OUTSIDE HOSPITAL AND TRANSFERRED. REVASCULARIZATION WAS ATTEMPTED BUT UNSUCCESSFUL. PRU 185 ON BRILLINTA.¿ PATIENT OUTCOME, FATAL. DATE OF DEATH: (B)(6) 2024. THE EVENT IS INDICATED AS PROBABLE RELATION TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE STUDY DISEASE. ADDITIONAL INFORMATION RECEIVED ON 28FEB2024: MEDICATION TYPE, TENECTEPLASE. INITIAL FRED TREATMENT DATE: (B)(6) 2024. DATE OF STENT OCCLUSION ONSET: (B)(6) 2024. CAUSE OF DEATH: ¿STENT OCCLUSION (AE1) TREATED WITH TNK CAUSING CONTRALATERAL INTRACRANIAL HEMORRHAGE (AE2) LEADING TO DEATH¿. THIS WAS A CASE OF DEVICE THROMBOSIS AND ¿OPEN THE STENT¿ HAS BEEN REFERRED TO AS REVASCULARIZING THE VESSEL I.E., TRYING TO CLEAR THE THROMBUS. THIS PATIENT WAS A NON-RESPONDER TO CLOPIDOGREL WITH PRU 186 ON (B)(6) 2024 (POD 0) AND PRU 185 ON BRILINTA AT AE1 ON (B)(6) 2024 (POD 5). IT IS NOT CLEAR IF IT WAS DUE TO A TRUE NON-RESPONDER OR NON-COMPLIANCE TO DAPT. ADDITIONAL INFORMATION, WHICH ARE PART OF THE INDEX PROCEDURE, RECEIVED ON 05MAR2024 INDICATED: ¿THERE WAS SOME DIFFICULTY WITH THE STENT OPENING AROUND THE CAVERNOUS GENUINE. THE STENT WAS PARTIALLY RECAPTURED AND THEN DEPLOYED. THERE IS STILL FELT TO BE SOME KINKING OF THE STENT. (¿) REPEAT SINGLE FRAME SHOT DEMONSTRATED THAT THE STENT WAS NOT MORE OPPOSED AND OPEN. A RUN DEMONSTRATED PATENCY OF THE STENT. THE DILUTED 3-D ANGIOGRAM WAS OBTAINED WHICH ALSO DEMONSTRATED THAT BOTH THE PROXIMAL AND DISTAL ENDS OF THE STENT WERE WELL OPPOSED. (¿)DURING FINAL DEPLOYMENT OF THE STENT WHICH DOES DEMONSTRATE THAT THE PORTION OF THE STENT ALONG THE CAVERNOUS GENUINE APPEARS TO BE KINKED. (¿)LATERAL VIEWS DEMONSTRATED THAT THE KINK HAD BEEN RESOLVED.(¿)BOTH THE PROXIMAL AND DISTAL ENDS OF THE FRED ARE OPEN WITHOUT ANY EVIDENCE OF IN-STENT STENOSIS.¿ MICROVENTION 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 MICROVENTION, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MICROVENTION 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, MICROVENTION, OR ITS EMPLOYEES THAT THE DEVICE, MICROVENTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2465127 | FRED X27 | INTRALUMINAL DEVICES | OUT | MICROVENTION, INC. | FREDX4023-PMA | 0000319838 | 00842429114360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Death |