SMART CONTROL
Report
- Report Number
- 9616099-2024-00259
- Event Type
- Injury
- Date Received
- August 9, 2024
- Date of Event
- July 16, 2024
- Report Date
- October 11, 2024
- Manufacturer
- CORDIS US CORP.
- Product Code
- NIO
- UDI-DI
- 10705032023504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AS REPORTED, WHEN A SMART CONTROL 6 X 40 120 SELF EXPANDING STENT (SES) WAS RELEASED DURING A MESENTERIC DISSECTION SURGERY, THE STENT JUMPED FORWARD SEVERELY AND WAS COMPLETELY OUT OF THE DISSECTION AREA. A NEW SMART CONTROL STENT WAS LATER USED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS MILD CALCIFICATION, MODERATE VESSEL TORTUOSITY AND SIXTY PERCENT (60%) STENOSIS AT TARGET SITE. THE PRODUCT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING NOR KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION AND THE LOCKING PIN WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT. THERE WAS NO UNUSUAL FORCE APPLIED DURING DEPLOYMENT OF THE STENT. MORE THAN HALF OF THE STENT WAS PRE-MATURELY DEPLOYED. THE STENT WAS NOT REMOVED; ANOTHER SMART CONTROL WAS IMPLANTED. THE TANTALUM MARKERS WERE OBSERVED TO OPEN SYMMETRICALLY; THE DEVICE WAS NOT ATTEMPTED TO BE DEPLOYED OUTSIDE THE BODY. THE DEVICE WAS RETURNED FOR ANALYSIS. A NON-STERILE ¿PKG ASSY 6X040 SMART VAS120CM¿ WAS RECEIVED COILED INSIDE OF A CLEAR PLASTIC BAG. THE DEVICE WAS UNPACKED FOR PRODUCT EVALUATION. THE STENT WAS RECEIVED IN ITS MANUFACTURING POSITION. AN OUTER SHEATH SEPARATION WAS OBSERVED APPROXIMATELY 117 CM FROM THE DISTAL TIP. NO OTHER DAMAGES OR ANOMALIES WERE NOTED ON THE RETURNED DEVICE. DIMENSIONAL ANALYSIS WAS CONDUCTED TO MEASURE THE SEPARATED AREA AND VERIFY THE INNER DIAMETER (ID) AND OUTER DIAMETER (OD) NEAR THE SEPARATION. THE ID/OD MEASUREMENTS WERE WITHIN SPECIFICATION. A FUNCTIONAL TEST WAS NOT PERFORMED DUE TO THE SEPARATED CONDITION OF THE OUTER SHEATH. THE SEPARATED AREA WAS ANALYZED USING A VISION SYSTEM, REVEALING THAT THE EDGES OF THE SEPARATED AREA SHOWED EVIDENCE OF ELONGATIONS. THESE ELONGATIONS AND PLASTIC DEFORMATIONS ARE TYPICALLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL WAS SUBJECTED TO A TENSILE FORCE EXCEEDING ITS YIELD STRENGTH BEFORE THE SEPARATION OCCURRED. ADDITIONALLY, THE STENT WAS NOTED TO BE IN ITS MANUFACTURING POSITION. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS NOT CONDUCTED AS THE DAMAGES ASSOCIATED WITH THE SEPARATION WERE VISIBLE WITH THE MAGNIFICATION PROVIDED BY A VISION SYSTEM. THE REPORTED ¿STENT DELIVERY SYSTEM (SDS) DEPLOYMENT DIFFICULTY- INACCURATE PLACEMENT¿ CANNOT BE CONFIRMED AS THE DEVICE WAS RECEIVED WITH THE STENT LOCATED IN THE SDS IN ITS MANUFACTURING POSITION. THEREFORE, THE EXACT CAUSE CANNOT BE DETERMINED. AN OUTER SHEATH SEPARATION ALONG WITH ELONGATIONS AND PLASTIC DEFORMATIONS WERE NOTED DURING DEVICE ANALYSIS. THIS PREVENTED SIMULATION OF THE DEPLOYMENT MECHANISM, THIS SEPARATION MAY HAVE BEEN A CONTRIBUTING FACTOR; HOWEVER, CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW IT IS LIKELY PROCEDURAL FACTORS AND DEVICE HANDLING CONTRIBUTED TO THE EVENTS REPORTED AS THE STENT IS STILL LOCATED WITHIN THE DEVICE AND NEVER DEPLOYED. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, FOR SMART CONTROL, ¿ENSURE LOCKING PIN IS STILL IN PLACE. NOTE: IF THE LOCKING PIN IS NOT IN PLACE, SYSTEM PERFORMANCE MAY BE COMPROMISED, AND ANOTHER SYSTEM SHOULD BE USED. ADVANCE THE STENT DELIVERY SYSTEM OVER THE GUIDEWIRE THROUGH THE SHEATH INTRODUCER TO THE LESION SITE. NOTE: IF RESISTANCE IS MET DURING DELIVERY SYSTEM INTRODUCTION, THE SYSTEM SHOULD BE WITHDRAWN AND ANOTHER SYSTEM SHOULD BE USED. CAUTION: ALWAYS USE AN APPROPRIATE SIZE INTRODUCER SHEATH FOR THE IMPLANT PROCEDURE TO PROTECT VESSEL AND ACCESS SITE. SLACK REMOVAL ADVANCE THE STENT DELIVERY SYSTEM PAST THE LESION SITE. PULL BACK THE STENT DELIVERY SYSTEM UNTIL THE RADIOPAQUE STENT MARKERS (LEADING AND TRAILING ENDS) MOVE IN POSITION SO THAT THEY ARE PROXIMAL AND DISTAL TO THE LESION SITE. ENSURE THAT THE STENT DELIVERY SYSTEM OUTSIDE THE PATIENT REMAINS FLAT AND STRAIGHT. CAUTION: SLACK IN THE CATHETER SHAFT EITHER OUTSIDE OR INSIDE THE PATIENT MAY RESULT IN DEPLOYING THE STENT BEYOND THE LESION SITE. STENT DEPLOYMENT: A. VERIFY THAT THE DELIVERY SYSTEM¿S RADIOPAQUE STENT MARKERS (LEADING AND TRAILING ENDS) ARE PROXIMAL AND DISTAL TO THE TARGET LESION. B. ENSURE THAT THE INTRODUCER SHEATH DOES NOT MOVE DURING DEPLOYMENT. C. REMOVE LOCKING PIN FROM HANDLE. D. INITIATE ONE-HANDED STENT DEPLOYMENT BY ROTATING THE TUNING DIAL WITH THUMB AND INDEX FINGERS IN A CLOCKWISE DIRECTION (DIRECTION OF ARROW) WHILE HOLDING THE HANDLE IN A FIXED POSITION [FIGURE 2]. E. WHILE USING FLUOROSCOPY, MAINTAIN POSITION OF THE RADIOPAQUE STENT MARKERS RELATIVE TO THE TARGETED LESION SITE. WATCH FOR THE DISTAL RADIOPAQUE MARKERS TO BEGIN SEPARATING. SEPARATION OF THE DISTAL STENT MARKERS SIGNALS THAT THE STENT IS UNSHEATHED. CONTINUE TURNING THE TUNING DIAL UNTIL THE DISTAL END OF THE STENT OBTAINS FULL APPOSITION WITH THE VESSEL WALL. NOTE: ONLY THE INITIAL 40 MM OF THE STENT MAY BE UNSHEATHED USING THE TUNING DIAL. F. WITH MAINTAINING A FIXED HANDLE POSITION, PULL BACK THE DEPLOYMENT LEVER TO UNSHEATHE THE REMAINDER OF THE STENT [FIGURE 3]. NOTE: FAILURE TO MAINTAIN A FIXED HANDLE POSITION OR CONSTRAINING THE CATHETER SHAFT DURING DEPLOYMENT MAY RESULT IN STENT COMPRESSION (SHORTENING) OR ELONGATION. NOTE: THE STENT MAY BE DEPLOYED USING TWO HANDS (¿PIN AND PULL¿ METHOD) BY HOLDING THE PROXIMAL END OF THE HANDLE STATIONARY WITH ONE HAND AND SLIDING THE DEPLOYMENT LEVER BACK TOWARDS THE STATIONARY HAND [FIGURE 4].¿ THE INFORMATION AVAILABLE DOES NOT SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.
THE DEVICE WAS RECEIVED FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, WHEN A SMART CONTROL 6 X 40 120 SELF EXPANDING STENT (SES) WAS RELEASED DURING A MESENTERIC DISSECTION SURGERY, THE STENT JUMPED FORWARD SEVERELY AND WAS COMPLETELY OUT OF THE DISSECTION AREA. A NEW SMART CONTROL STENT WAS LATER USED. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS MILD CALCIFICATION, MODERATE VESSEL TORTUOSITY AND SIXTY PERCENT (60%) STENOSIS AT TARGET SITE. THE PRODUCT WAS STORED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING NOR KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE SMART CONTROL LOCKING PIN WAS IN PLACE DURING ADVANCEMENT TOWARDS THE LESION AND THE LOCKING PIN WAS REMOVED BEFORE ATTEMPTING TO DEPLOY THE SMART CONTROL STENT. THE USER HELD THE HANDLE OF THE SMART CONTROL SDS FLAT AND STRAIGHT OUTSIDE THE PATIENT. THERE WAS NO UNUSUAL FORCE APPLIED DURING DEPLOYMENT OF THE STENT. MORE THAN HALF OF THE STENT WAS PRE-MATURELY DEPLOYED. THE STENT WAS NOT REMOVED; ANOTHER SMART CONTROL WAS IMPLANTED. THE TANTALUM MARKERS WERE OBSERVED TO OPEN SYMMETRICALLY; THE DEVICE WAS NOT ATTEMPTED TO BE DEPLOYED OUTSIDE THE BODY. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2200071 | SMART CONTROL | STENT, ILIAC | NIO | 18218585 | 10705032023504 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | 4*40 6*40 UNKNOWN STENT.| 6F 11CMAVANTI. 5FPIG MPA. |