CASPER 5F
Report
- Report Number
- 2032493-2025-00157
- Event Type
- Injury
- Date Received
- February 22, 2025
- Date of Event
- August 1, 2024
- Report Date
- March 31, 2025
- Manufacturer
- MICROVENTION INC.
- Product Code
- NIM
- UDI-DI
- 00842429111857
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE PRODUCT REPORTED IN THIS REPORT IS AN EXPORTED DEVICE NOT CLEARED OR APPROVED FOR MARKETING IN THE US. THE COMPLAINT IS BEING REPORTED BASED ON THIS PRODUCT MEETING SIMILAR PRODUCT CRITERIA (SIMILAR TO ROADSAVER/CASPER CAROTID STENT DEVICE ¿ PMA # P210030). 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 IMPLANTED AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION BY THE MANUFACTURER. HOWEVER, MEDICAL INFORMATION WAS PROVIDED AND WILL BE REVIEWED. THE INVESTIGATION IS ONGOING AND UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
PROCEDURE/MEDICAL INFORMATION REVIEW: A DETAILED MEDICAL REVIEW OF MEDICAL REPORT DATA DATED (B)(6) 2024, WAS PERFORMED ON (B)(6) 2025. MEDICAL DATA REVIEWED INDICATES THAT AS REPORTED, DURING THE PERFORMANCE OF A MECHANICAL THROMBECTOMY PROCEDURE, THE PATIENT WAS TREATED WITH A CASPER X DEVICE FOR THE TREATMENT OF A DIAGNOSED ACUTE TANDEM OCCLUSION, ATHEROSCLEROTIC PLAQUE STENOSIS LOCATED AT THE BIFURCATION CCA-ICA. INDEX PROCEDURE DATE WAS (B)(6) 2024. DURING THE PERFORMANCE OF THE PROCEDURE WHICH OCCURRED ON (B)(6)2024, THE PATIENT EXPERIENCED AN IN-STENT THROMBOSIS AFTER STENT-DEPLOYMENT DUE TO ADDITIONAL CAROTID-T OCCLUSION AND THEREFORE, NO FLOW ON THE LCI ARTERY WAS DIAGNOSED. AFTER STENT-RETRIEVAL OF THE INTRACRANIAL OCCLUSION AND MULTIPLE ASPIRATION MANEUVERS WITHIN THE CASPER X DEVICE, THROMBOTIC MATERIAL WAS REMOVED WHICH RESULTED IN SUFFICIENT IN-STENT BLOOD FLOW. THE PATIENT RECEIVED TREATMENT WITH ASA 500 MG, WITH THE OPERATIVE PHYSICIAN REPORTING THAT THE IN-STENT THROMBOSIS WAS CAUSED DUE TO NO BLOOD FLOW AT THE TIME OF STENT DEPLOYMENT. AT THE END OF THE PROCEDURE THE PATIENT HAD A 2C TICI, WITH OPERATIVE PHYSICIAN REPORTED AS DOING VERY WELL. CT CONTROL NEXT DAY SHOWED THE STENT HAD NO THROMBUS MATERIAL AND THE PATIENT IS DOING WELL. THE PATIENT'S OUTCOME/CURRENT STATUS IS REPORTED AS HEMIPARESIS, APHASIA, NIHSS 31 (STARTED WITH NIHSS 30), 50% STENOSE LEFT (INCREASED WITHIN 24H), MRS 5. BASED ON A REVIEW OF THE AVAILABLE MEDICAL DATA AND IN MY PROFESSIONAL OPINION, THE RELATIONSHIP OF THE REPORTED EVENT TO THE CASPER X CAN BE RULED OUT AS THE OPERATIVE PHYSICIAN HAS DECLARATIVELY STATED THAT AN IN-STENT THROMBOSIS AFTER STENT-DEPLOYMENT OCCURRED DUE TO ADDITIONAL CAROTID-T OCCLUSION AND THEREFORE, NO FLOW ON THE LCI ARTERY WAS DIAGNOSED AND THE IN-STENT THROMBOSIS CAUSATION WAS DUE TO NO BLOOD FLOW AT THE TIME OF STENT DEPLOYMENT. NO DEVICE MALFUNCTION WAS REPORTED AND/OR NO DEVICE MALFUNCTION WAS REPORTED AS THE CAUSE OF THE IN-STENT THROMBOSIS EVENT. INVESTIGATION FINDINGS: WITHOUT THE RETURN AND PHYSICAL EVALUATION OF THE DEVICE, THE INVESTIGATION CANNOT FURTHER EXAMINE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE 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 AN ANALYSIS OF THE DEVICE, THIS INVESTIGATION CANNOT IDENTIFY WITH CERTAINTY ANY POTENTIAL ROOT CAUSES. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU): POTENTIAL COMPLICATIONS POSSIBLE COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: ¿ ARRHYTHMIA ¿ ANEURYSM AND PSEUDOANEURYSM FORMATION ¿ ABRUPT VESSEL CLOSURE ¿ ALLERGIC REACTIONS (INCLUDING TO ANTIPLATELET AGENTS, CONTRAST MEDIUM OR STENT MATERIALS) ¿ ARTERIOVENOUS FISTULA ¿ BLEEDING FROM ANTICOAGULATION/ANTIPLATELET MEDICATION ¿ BRADYCARDIA AND HYPOTENSION ¿ CAROTID ARTERY SPASM ¿ CORONARY ISCHEMIA ¿ DEATH ¿ DISSEMINATED INTRAVASCULAR COAGULATION ¿ EMBOLI (AIR, TISSUE, PLAQUE, THROMBUS, DEVICE OR OTHER) ¿ EMERGENCY ARTERY BYPASS GRAFT SURGERY ¿ HEMATOMA ¿ HEMORRHAGIC OR EMBOLIC STROKE/TIA ¿ INFECTION AND/OR PAIN AT INSERTION SITE/SEPSIS ¿ INTIMAL TEAR/DISSECTION ¿ MYOCARDIAL INFARCTION (MI) ¿ NEW OR WORSE ENCEPHALOPATHY ¿ RENAL FAILURE/INSUFFICIENCY ¿ RESPIRATORY ARREST ¿ STENT MISPLACEMENT ¿ TISSUE NECROSIS ¿ VESSEL INJURY/DISSECTION/PERFORATION/RUPTURE/TRAUMA ¿ VESSEL OCCLUSION OR THROMBOSIS ¿ VESSEL SPASM OR RECOIL. WARNINGS SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING ACCESS OR REMOVAL, THE SHEATH INTRODUCER/GUIDE CATHETER AND CASPER X SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE DURING DELIVERY OR RETRIEVAL OF THE CASPER X SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE DEVICE AND DELIVERY COMPONENTS. IF AN EPD DEVICE IS USED, ALLOW FOR AND MAINTAIN ADEQUATE DISTANCE BETWEEN THE FILTER, THE STENT DELIVERY SYSTEM OR DEPLOYED STENT TO AVOID POTENTIAL ENTANGLEMENT. DO NOT REPOSITION THE CASPER X SYSTEM WITHOUT FULLY RETRIEVING THE DEVICE. THE CASPER X STENT MUST BE RETRIEVED INTO THE DELIVERY SYSTEM AND REDEPLOYED AT THE DESIRED TARGET LOCATION OR REMOVED COMPLETELY FROM THE PATIENT. THE USE OF A GUIDING SHEATH OR GUIDING CATHETER WITH A FIXED HEMOSTASIS VALVE MAY CAUSE THE DISTAL TIP OF THE DELIVERY CATHETER TO DETACH AT THE HEMOSTASIS VALVE UPON REMOVAL IF THE VALVE IS NOT ADEQUATELY OPENED. PRECAUTIONS EXERCISE CAUTION WHEN CROSSING THE DEPLOYED/DETACHED CASPER X SYSTEM WITH ADJUNCTIVE DEVICES SUCH AS GUIDEWIRES, CATHETERS OR BALLOON CATHETERS TO AVOID DISRUPTING THE DEVICE GEOMETRY AND DEVICE PLACEMENT. DIRECTIONS FOR USE INTRODUCTION OF THE STENT DELIVERY SYSTEM ACCESS THE TREATMENT SITE USING THE APPROPRIATE ACCESSORY EQUIPMENT AND INSERT AN EPD USABLE AS A GUIDEWIRE. IF AN EPD IS NOT PREFERRED, USE A SUFFICIENTLY LONG .014¿ GUIDEWIRE AND PLACE IT ACROSS THE LESION. WARNING: ALWAYS USE A GUIDEWIRE OR EPD WHEN ADVANCING OR WITHDRAWING THE DELIVERY SYSTEM. IF NECESSARY, PERFORM A PRE-DILATATION AT THE LESION TARGET SITE USING A STANDARD PTA TECHNIQUE USING THE RECOMMENDED GUIDE SHEATH OR GUIDING CATHETER ON THE OUTER BOX LABEL. THE GUIDE WIRE OR EPD DEVICE SHOULD BE ADVANCED PAST THE TARGET LESION SITE. THEN THE DELIVERY SYSTEM SHOULD BE ADVANCED OVER THE GUIDE WIRE OR EPD TO THE LESION SITE USING FLUOROSCOPY. CAUTION: DO NOT ADVANCE THE DELIVERY SYSTEM AGAINST SIGNIFICANT RESISTANCE. THE CAUSE OF THE RESISTANCE SHOULD BE DETERMINED BY FLUOROSCOPY AND REMEDIAL ACTION TAKEN. WITHDRAW THE SYSTEM AND USE A NEW ONE. SLACK REMOVAL ENSURE THAT THE DELIVERY SYSTEM CATHETER OUTSIDE THE PATIENT REMAINS FLAT AND STRAIGHT. WARNING: SLACK IN THE DELIVERY SYSTEM CATHETER EITHER OUTSIDE OR WITHIN THE PATIENT MAY RESULT IN MISPLACEMENT OF THE STENT BEYOND THE LESION. STENT DEPLOYMENT NOTE: THE CASPER X STENT SHOULD BE SIZED TO THE VESSEL ACCORDING TO THE REFERENCE VESSEL DIAMETER RANGE LISTED ON THE PRODUCT LABEL. THE CASPER X STENT FORESHORTENS AS IT EXPANDS TO THE DIAMETER OF THE NATIVE VESSEL. THE STENT FORESHORTENING SHOULD BE TAKEN INTO ACCOUNT WHEN SIZING AND DEPLOYING THE CASPER X CAROTID STENT SYSTEM. IF THE CASPER X STENT POSITIONING IS NOT SATISFACTORY ACROSS THE TARGET LESION, THE STENT MAY BE RECAPTURED AND REPOSITIONED IF IT IS NOT FULLY DEPLOYED. THE IMPLANT MAY BE RECAPTURED UP TO 50% OF ITS DEPLOYMENT FROM THE CATHETER DELIVERY SYSTEM (SEE FIGURE 5 AND 6). RECAPTURING OF STENT CAN BE ACCOMPLISHED BY REMOVING THE SLACK IN THE DELIVERY CATHETER SHAFT AND THEN MAINTAINING THE INNER CATHETER (HANDLE) POSITION AND ADVANCING OR PUSHING FORWARD THE OUTER CATHETER. AFTER RECAPTURING THE STENT INTO THE DELIVERY SYSTEM THEN YOU CAN REDEPLOY THE STENT ACROSS THE LESION, TAKING INTO CONSIDERATION THE FORESHORTENING OF THE STENT. ENSURE THE RHV IS OPEN. THE STENT IS DEPLOYED BY OUTER CATHETER RETRACTION. DEPLOYMENT IS COMPLETE BY MAINTAINING INNER CATHETER POSITION (HOLDING HANDLE) WHILE RETRACTING THE OUTER CATHETER AND ALLOWING THE STENT TO EXPAND (SEE FIGURE 4). WITHDRAWING STENT DELIVERY SYSTEM AFTER THE STENT HAS BEEN COMPLETELY DEPLOYED, USING FLUOROSCOPY, WITHDRAW THE DELIVERY SYSTEM CAREFULLY, LEAVING THE GUIDEWIRE OR EPD IN PLACE. PERFORM STANDARD POST-PROCEDURAL ANGIOGRAPHY. POST-DEPLOYMENT STENT DILATATION IF THE STENT IS NOT COMPLETELY EXPANDED WITHIN THE LENGTH OF THE LESION, POST-DILATION WITH THE BALLOON CATHETER INSIDE THE STENT MAY BE DONE WITH STANDARD PTA TECHNIQUE. THE INFLATED NOMINAL DIAMETER OF THE PTA BALLOON USED FOR POST-DILATION SHOULD BE APPROXIMATELY THE SAME AS THE DIAMETER OF THE REFERENCED NATIVE VESSEL.
IT WAS REPORTED THAT DURING A TANDEM OCCLUSION TREATMENT, THE PATIENT WAS TREATED USING A CAROTID STENT. THE VESSEL DIAMETER MEASURED 8.9 PROXIMAL. AFTER THE STENT DEPLOYMENT, INITIAL IN-STENT THROMBOSIS OCCURRED DUE TO ADDITIONAL CAROTID-T OCCLUSION. THEREFORE, THERE WAS NO FLOW ON THE LCI ARTERY. AFTER STENT-RETRIEVAL OF THE INTRACRANIAL OCCLUSION AND MULTIPLE ASPIRATION MANEUVERS WITHIN THE CAROTID STENT, THE THROMBOTIC MATERIAL WAS REMOVED. AFTERWARDS, THERE WAS SUFFICIENT IN-STENT BLOOD FLOW. AT THE END OF THE PROCEDURE, THE PATIENT HAD A 2C TICI, VERY GOOD RESULTS. CT CONTROL NEXT DAY SHOWED THE STENT HAD NO THROMBUS MATERIAL AND THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED BY GIVING THE PATIENT TIROFIBAN MEDICATION, AND THE STENT WAS CLEAR WITH 30% STENOSIS LEFT. THE PATIENT¿S CURRENT STATUS AND OUTCOME WAS REPORTED AS ¿HEMIPARESIS, APHASIA, NIHSS 31 (STARTED WITH NIHSS 30), 50% STENOSIS LEFT (INCREASED WITHIN 24HOURS), MRS 5.¿ THERE WAS NO FURTHER TREATMENT DONE.
SEE H11.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1268008 | CASPER 5F | STENT CAROTID | NIM | MICROVENTION INC. | XCPR-1030-143RX-ME | 536030 | 00842429111857 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |