CASPER X 5F
Report
- Report Number
- 2032493-2025-00155
- Event Type
- Injury
- Date Received
- February 22, 2025
- Date of Event
- December 24, 2024
- Report Date
- April 3, 2025
- Manufacturer
- MICROVENTION, INC.
- Product Code
- NIM
- UDI-DI
- 00842429111826
- 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). INVESTIGATION FINDINGS: ITEMS RETURNED: N/A; DEVICE REMAINS IMPLANTED IN THE PATIENT. 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 WERE NOT PROVIDED FOR THIS INVESTIGATION. 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. WITHOUT IMAGING, THE INVESTIGATION CANNOT FURTHER VERIFY IF THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EVALUATE THE CAUSE OF 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 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. 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. INVESTIGATION CONCLUSION: THE PHYSICAL DEVICE WAS NOT AVAILABLE FOR EVALUATION TO INVESTIGATE IF A CONDITION EXISTED THAT WOULD HAVE CONTRIBUTED TO EVENT. SUPPLEMENTAL IMAGING WAS ALSO UNAVAILABLE FOR REVIEW; WITHOUT IMAGING, THE INVESTIGATION CANNOT VERIFY THE EVENT OCCURRED AS DESCRIBED, NOR COULD THE INVESTIGATION FURTHER EXAMINE THE CAUSE OF THE REPORTED EVENT. THIS INFORMATION MAY BE UPDATED IF ADDITIONAL INFORMATION IS PROVIDED AT A LATER DATE.
MEDICAL REPORT REVIEW: A DETAILED REVIEW OF THE MEDICAL REPORT WAS PERFORMED. AS REPORTED, A THROMBECTOMY WAS PERFORMED FOR THE TREATMENT OF A TANDEM OCCLUSION WITH ATHEROSCLEROTIC PLAQUE AT CCA-ICA BIFURCATION WITH IDENTIFIED (99% STENOSIS). INDEX PROCEDURE DATE WAS (B)(6) 2024. DATA REVIEWED INDICATES THAT A SOFIA PLUS WAS USED TOGETHER WITH SOLITAIRE X 4X20MM FOR A THROMBECTOMY. THE INTRACRANIAL OCCLUSION WAS TREATED, FOLLOWED BY TREATMENT OF THE CAROTID STENOSIS. PLACEMENT OF A CASPER X WAS COMPLETED POST-PERFORMANCE OF DILATION DURING THE PERFORMANCE OF THE MECHANICAL THROMBECTOMY. CLOTTING OCCURRED IMMEDIATELY AFTER PLACEMENT OF THE 9MM X 20MM CASPER X STENT DEVICE. PROMINENT APPOSITIONAL CLOTTING WAS TREATED BY ASPIRATION TO REMOVE THE THROMBUS. BASED ON A REVIEW OF THE MEDICAL REPORT DATA AVAILABLE AND PROFESSIONAL MEDICAL OPINION, AS REPORTED, A THROMBUS/CLOTTING WAS IDENTIFIED ON THE 9MM X 20MM CASPER X STENT IMMEDIATELY AFTER PLACEMENT WHICH WAS TREATED WITH ASPIRATION TO REMOVE THE CLOT. THE RELATIONSHIP OF THE EVENT TO THE CASPER X DEVICE CANNOT BE RULED OUT. NO DEVICE MALFUNCTION WAS REPORTED AS ASSOCIATED WITH THE REPORTED THROMBUS/CLOTTING AND/OR NO DEVICE MALFUNCTION WAS REPORTED AS THE CAUSE OF THE REPORTED THROMBUS/CLOTTING.
AS REPORTED: RELATIVELY EARLY AND PROMINENT APPOSITIONAL CLOTTING TREATED BY ASPIRATION. TREATMENT OF A TANDEM OCCLUSION WITH AN ATHEROSCLEROTIC PLAQUE AT CCA-ICA BIFURCATION (99% STENOSIS) AND MCA OCCLUSION. THE PROCEDURE WAS PERFORMED WITH A GUIDING CATHETER / SHEATH. 6F CATHETER WAS USED TOGETHER WITH 4MM X 20MM REVASCULARIZATION DEVICE FOR THROMBECTOMY. FIRST THE INTRACRANIAL OCCLUSION WAS TREATED, THEN THE CAROTID STENOSIS. AFTER PLACEMENT OF CASPER X, A POST DILATION WAS PERFORMED. AFTER 9MM X 20MM CASPER X STENT DEPLOYMENT DURING THE PROCEDURE, THE PHYSICIANS NOTICED THROMBUS / CLOTTING ON THE STENT IMMEDIATELY AFTER PLACEMENT. ASPIRATION WAS USED TO REMOVE THE THROMBUS. BEFORE PROCEDURE THE PATIENT HAD TAKEN ASA, SO NO ASA IV WAS ADMINISTERED. THE PATIENT WENT TO REHABILITATION CENTER, NIHSS 13, MRS 5, STATUS REMAINED NOT WELL, NO WORSENING. PRE-PROCEDURE: 100MG ASA. AT DISCHARGE: 100MG ASA, DAPT, AND 75MG CLOPIDOGREL.
PLEASE SEE SECTION H11 FOR REVIEW OF THE MEDICAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1109098 | CASPER X 5F | STENT, CAROTID | NIM | MICROVENTION, INC. | XCPR-0920-143RX-ME | 0000415882 | 00842429111826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | 8F VISTA BRITE TIP GUIDE CATHETER.| SOFIA PLUS 6F.| SOLITAIRE X 4X20MM: MEDTRONIC.| TRAXCESS 14 GUIDEWIRE. |