SOLITAIRE FR2

Additional Manufacturer Narrative

THE SOLITAIRE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. THE DEVICE WAS NOT RETURNED; THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

MEDTRONIC RECEIVED REPORT OF SOLITAIRE PUSHWIRE SEPARATION. THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY PROCEDURE. THE PATIENT¿S VASCULATURE WAS REPORTED TO BE SEVERE IN TORTUOSITY. IT WAS REPORTED THAT DURING THE PROCEDURE, A SOLITAIRE STENT WAS ADVANCED WITH RESISTANCE IN THE MICROCATHETER. DUE TO THE RESISTANCE, THE PHYSICIAN REMOVED THE SOLITAIRE FROM THE MICROCATHETER. OUTSIDE OF THE PATIENT, THE SOLITAIRE PUSHWIRE WAS OBSERVED TO BE BROKEN IN THE DISTAL SECTION. THE PHYSICIAN REPORTEDLY HAD NOT TORQUE PUSHWIRE DURING ADVANCEMENT. ALL COMPONENTS WERE REMOVED THROUGH THE CATHETER FROM THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT.

Additional Manufacturer Narrative

THE SOLITAIRE 2 REVASCULARIZATION DEVICE WAS RETURNED FOR ANALYSIS WITHOUT THE REBAR-18 AS IT WAS DISCARDED AT THE SITE. THE SOLITAIRE 2 REVASCULARIZATION DEVICE WAS EXAMINED WITHIN THE INTRODUCER SHEATH. THE STENT WAS UNABLE TO BE PUSHED OUT FROM WITHIN THE INTRODUCER SHEATH; THEREFORE, WAS GENTLY PULLED PROXIMALLY OUT. THE SOLITAIRE 2 PUSHWIRE WAS FOUND TO BE BROKEN WITHIN THE STRETCHED PTFE SHRINK TUBING AT APPROXIMATELY 173.6CM FROM THE PUSHWIRE¿S PROXIMAL END WHICH IS APPROXIMATELY 9.2CM FROM ATTACHMENT ZONE (PROXIMAL MARKER) AND RETAINED BY THE PTFE SHRINK TUBING. DUE TO ITS DAMAGED CONDITION, THE SOLITAIRE 2 REVASCULARIZATION DEVICE COULD NOT BE USED FOR RESISTANCE TESTING. THE PUSHWIRE¿S PROXIMAL BROKEN END WAS CUT AND SENT OUT FOR SEM (SCANNING ELECTRON MICROSCOPY) ANALYSIS. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿SEPARATION¿ WAS CONFIRMED AS THE PUSHWIRE WAS FOUND TO BE BROKEN. PER THE SEM (SCANNING ELECTRON MICROSCOPY) ANALYSIS REPORT, ¿THE CRACK INITIATED FROM THE BAR OUTER SURFACE VIA FATIGUE. REST OF THE FRACTURE SURFACE EXHIBITS DUCTILE OVERLOAD FEATURES.¿ IT IS LIKELY THE PUSHWIRE BROKE AS A RESULT OF EXCESSIVE FORCE (PUSHING/PULLING) AGAINST THE REPORTED RESISTANCE. PRODUCT LABELING WAS REVIEWED AND PROVIDES SEVERAL CONTRAINDICATIONS, COMPLICATIONS, WARNINGS, AND INSTRUCTIONS FOR THE USE AND HANDLING OF THE DEVICE IN ORDER TO PREVENT DAMAGE AND SEPARATION. BASED ON THE FORMAL INVESTIGATION CONDUCTED, DEVICE SEPARATION CAN OCCUR DUE TO ANATOMICAL CONSIDERATIONS (LEVEL OF TORTUOSITY, VARIANTS OF ANATOMY AT THE AORTIC ARCH OR NEUROVASULATURE); DELIVERY AND RETRIEVAL FRICTION; HIGHER NUMBER OF DEVICE PASSES; CATHETER INTEGRITY ISSUES SUCH AS KINKING WITHIN THE SHAFT; PRESENCE OF HARD CLOTS / THROMBUS ENTANGLEMENT WITH OVERBENDING DURING THE RETRACTION PROCESS; ALIGNMENT OF THE MICROCATHETER WITH THE PROXIMAL END OF THE SOLITAIRE DEVICE OR REMOVAL OF THE MICROCATHETER PRIOR TO RETRIEVAL OF THE SOLITAIRE DEVICE. THE SOLITAIRE 2 PRODUCT ANALYSIS DOES NOT SUGGEST A POTENTIAL OR CONFIRMED MANUFACTURING ISSUE. IN ADDITION, THE REBAR-18 COMPLAINT INVESTIGATION DOES NOT INDICATE A POTENTIAL OR CONFIRMED MANUFACTURING ISSUE. THEREFORE, NO LOT HISTORY RECORD REVIEW IS REQUIRED. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. AS NOTED IN THE SOLITAIRE PLATINUM IFU (INSTRUCTIONS FOR USE): ¿IF EXCESSIVE RESISTANCE IS ENCOUNTERED DURING RECOVERY OF THE SOLITAIRE¿ PLATINUM REVASCULARIZATION DEVICE, DISCONTINUE THE RECOVERY AND IDENTIFY THE CAUSE OF THE RESISTANCE.¿ IN ADDITION, ¿TO PREVENT DEVICE SEPARATION: DO NOT OVERSIZE DEVICE; DO NOT RECOVER (I.E. PULL BACK) THE DEVICE WHEN ENCOUNTERING EXCESSIVE RESISTANCE. INSTEAD, RESHEATH THE DEVICE WITH THE MICROCATHETER AND THEN, REMOVE THE ENTIRE SYSTEM UNDER ASPIRATION. IF RESISTANCE IS ENCOUNTERED DURING RESHEATHING, DISCONTINUE AND REMOVE THE ENTIRE SYSTEM UNDER ASPIRATION; DO NOT TREAT PATIENTS WITH KNOWN STENOSIS PROXIMAL TO THE THROMBUS SITE.¿ IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.