CASPER X
Report
- Report Number
- 2032493-2025-00160
- Event Type
- Injury
- Date Received
- February 23, 2025
- Date of Event
- December 28, 2023
- Report Date
- April 3, 2025
- Manufacturer
- MICROVENTION, INC.
- Product Code
- NIM
- 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). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A SEARCH FOR PRODUCTION-RELATED NON-CONFORMANCES COULD NOT BE PERFORMED. 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.
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. 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. 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. BATCH REVIEW: A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART / LOT NUMBER COMBINATION COULD NOT BE PERFORMED AS THIS INFORMATION WAS NOT AVAILABLE AT THE TIME THIS INVESTIGATION WAS PERFORMED. COMPLAINT SYSTEM REVIEW: A SEARCH OF THE COMPLAINT HANDLING SYSTEM COULD NOT BE PERFORMED TO DETERMINE IF OTHER SIMILAR COMPLAINTS EXIST FOR THIS BATCH NUMBER, BECAUSE THE BATCH NUMBER WAS NOT PROVIDED FOR THE PRODUCT ON THIS COMPLAINT FILE. 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. PROCEDURE/MEDICAL INFORMATION REVIEW: A DETAILED MEDICAL REVIEW OF THE PROCEDURE NOTE WAS PERFORMED. PATIENT WAS RECEIVING TREATMENT WITH A CASPER¿ X DEVICE FOR A TANDEM OCCLUSION WITH AN ATHEROSCLEROTIC PLAQUE AT CCA-ICA BIFURCATION WITH (100% STENOSIS) DIAGNOSED. DURING THE PERFORMANCE OF THE PROCEDURE ((B)(6) 2023), AND AFTER CASPER¿ X STENT DEPLOYMENT WITH STENT, WHICH WAS REPORTED TO HAVE FULLY OPENED, THE OPERATIVE PHYSICIAN REPORTED APPOSITION THROMBUS ON THE DEPLOYED STENT. THE THROMBUS WAS TREATED WITH TIROFIBAN, AND THE THROMBUS WAS REPORTED AS DISSOLVED. THE PATIENT IS DOING WELL AND WAS FEELING BETTER THE NEXT DAY; THE PATIENT STARTED WITH TICI 0 AND FINAL 2C. BASED ON A REVIEW OF THE AVAILABLE MEDICAL REPORT DATA AND PROFESSIONAL MEDICAL OPINION AND INTRAOPERATIVE STENT THROMBOSIS OCCURRED DURING THE PERFORMANCE OF THE PROCEDURE FOR THE TREATMENT OF A TANDEM OCCLUSION WITH AN ATHEROSCLEROTIC PLAQUE AT CCA-ICA BIFURCATION WITH A CASPER¿ X DEVICE AND THE RELATIONSHIP TO THE DEVICE CANNOT BE RULED OUT. NO DEVICE MALFUNCTION WAS REPORTED AS ASSOCIATED WITH THE REPORTED THROMBUS AND/OR NO DEVICE MALFUNCTION WAS REPORTED AS THE CAUSE OF THE REPORTED THROMBUS. INVESTIGATION CONCLUSION: A MEDICAL REVIEW OF THE PROVIDED MEDICAL REPORT WAS PERFORMED. AS REPORTED, THE PATIENT WAS RECEIVING TREATMENT WITH A CASPER¿ X DEVICE FOR A TANDEM OCCLUSION WITH AN ATHEROSCLEROTIC PLAQUE AT CCA-ICA BIFURCATION WITH (100% STENOSIS) DIAGNOSED. DURING THE PERFORMANCE OF THE PROCEDURE ((B)(6) 2023), AND AFTER CASPER¿ X STENT DEPLOYMENT, WHICH WAS REPORTED TO HAVE FULLY OPENED, THE OPERATIVE PHYSICIAN REPORTED APPOSITION THROMBUS ON THE DEPLOYED STENT. THE THROMBUS WAS TREATED WITH TIROFIBAN, AND THE THROMBUS WAS REPORTED AS DISSOLVED. THE PATIENT IS DOING WELL AND WAS FEELING BETTER THE NEXT DAY; THE PATIENT STARTED WITH TICI 0 AND FINAL 2C. BASED ON A REVIEW OF THE AVAILABLE MEDICAL REPORT DATA, INTRAOPERATIVE STENT THROMBOSIS OCCURRED DURING THE PERFORMANCE OF THE PROCEDURE FOR THE TREATMENT OF A TANDEM OCCLUSION WITH AN ATHEROSCLEROTIC PLAQUE AT CCA-ICA BIFURCATION WITH A CASPER¿ X DEVICE AND THE RELATIONSHIP TO THE DEVICE CANNOT BE RULED OUT. NO DEVICE MALFUNCTION WAS REPORTED AS ASSOCIATED WITH THE REPORTED THROMBUS AND NO DEVICE MALFUNCTION WAS REPORTED AS THE CAUSE OF THE REPORTED THROMBUS. SUPPLEMENTAL IMAGING WAS UNAVAILABLE FOR REVIEW. WITHOUT THE RETURN AND EVALUATION OF THE PHYSICAL DEVICE, THE INVESTIGATION CANNOT FURTHER EXAMINE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.
AS REPORTED: STENT THROMBOSIS DURING A TANDEM OCCLUSION. TREATMENT OF A TANDEM OCCLUSION WITH AN ATHEROSCLEROTIC PLAQUE AT CCA-ICA BIFURCATION (100% STENOSIS). PRE-DILATION AND POST STENTING DILATION BALLOON ANGIOPLASTY PERFORMED AT THE CAROTID STENOSIS. DURING THE PROCEDURE, AFTER STENT DEPLOYMENT, THE PHYSICIANS NOTICED APPOSITION THROMBUS ON THE STENT. THE PHYSICIANS GAVE TIROFIBAN, AND THE THROMBUS WAS DISSOLVED. THE PATIENT IS DOING WELL AND WAS FEELING BETTER THE NEXT DAY; THE PATIENT STARTED WITH TICI 0 AND FINAL 2C. PERI-PROCEDURE: TIROFIBAN, SAPT. POST-PROCEDURE: 100MG ASA, 90MG CLOPIDOGREL, DAPT. AT DISCHARGE: 100MG ASA, 90MG CLOPIDOGREL, DAPT.
PLEASE SEE SECTION H11 FOR INVESTIGATION AND MEDICAL REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1472114 | CASPER X | STENT, CAROTID | NIM | MICROVENTION, INC. | XCPR-0630-143RX-ME | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | BALENCE MIDDLE GUIDEWIRE| SOPHIA 6F| TREVO, SOLITAIRE |