SMART CONTROL
Report
- Report Number
- 9616099-2024-00243
- Event Type
- Injury
- Date Received
- July 23, 2024
- Report Date
- July 30, 2024
- Manufacturer
- CORDIS US. CORP
- Product Code
- FGE
- PMA / PMN Number
- K042969
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AS REPORTED, APPROXIMATELY 15 MONTHS AFTER A 6X150 NON-CORDIS STENT WAS IMPLANTED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND A 6X150MM SMART CONTROL SELF-EXPANDING STENT (SES) WAS PLACED IN THE PROXIMAL SFA. THE DISTAL PORTION HAD A STENOSIS, AND THE PROXIMAL PORTION HAD A CHRONIC TOTAL OCCLUSION (CTO). THE PREOPERATIVE CT SCAN FOR CANCER AT THE GASTROINTESTINAL SURGERY DEPARTMENT REVEALED A PSEUDOANEURYSM AT THE STENT SITE. AS A RESULT, A PROCEDURE WAS PERFORMED. A PSEUDOANEURYSM MEASURING APPROXIMATELY 5 MM WAS FOUND AT THE SITE OF THE SMART CONTROL STENT PLACEMENT AND WAS SURGICALLY REMOVED. SINCE THE AREA WHERE THE PSEUDOANEURYSM WAS FOUND HAD NO INTIMAL COVERING AND THE STENT WAS EXPOSED, THE STENT WAS REMOVED AND CONNECTED TO AN ARTIFICIAL BLOOD VESSEL, AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAD NO CURRENT SYMPTOMS, BUT IT WAS LATER DISCOVERED THAT HE HAD EXPERIENCED SWELLING IN HIS THIGH IMMEDIATELY AFTER EVT. AN UNKNOWN STENT WAS PLACED WHERE THE UNKNOWN WIRE PASSED THROUGH THE FALSE LUMEN DURING THE EVT. THE CINE-IMAGE AFTER THE EVT SHOWED BLOOD LEAKING OUT OF THE BLOOD VESSEL, SO THE DOCTOR COMMENTED THAT THIS MAY HAVE BEEN THE CAUSE OF THE ANEURYSM. THE LEAK IN THE VESSEL WAS RESOLVED. THE PSEUDOANEURYSM WAS NOT REMOVED. THE PATIENT IS NOTED TO BE IN GOOD STATUS. THE REPORTED ¿PSEUDOANEURYSM¿ AS A RESULT OF USING THE PRODUCT, COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, NOR WERE PROCEDURAL IMAGES PROVIDED; ADDITIONALLY, NO DEVICE MALFUNCTION WAS REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL DAMAGE, SUCH AS A PSEUDOANEURYSM, IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY PROCEDURE IN WHICH MULTIPLE DEVICES ARE INTRODUCED INTO THE PATIENT. IN THIS CASE THE PATIENT HAD STENT PLACEMENT APPROXIMATELY 15 MONTHS AGO IN THE DISTAL AND PROXIMAL SECTIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THIS INVOLVES THE INTRODUCTION OF A SHEATH, STIFF GUIDEWIRES, BALLOONS, CATHETERS, AND STENTS, ANY OF THESE DEVICES COULD HAVE LED TO A PSEUDOANEURYSM FORMATION. ACCORDING TO THE WARNINGS IN THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE, ¿THE STENT IS NOT DESIGNED FOR REPOSITIONING OR RECAPTURING. ONCE THE STENT IS PARTIALLY DEPLOYED, IT CANNOT BE RECAPTURED USING THE STENT DELIVERY SYSTEM. AVOID STENT PLACEMENT THAT MAY OBSTRUCT ACCESS TO A VITAL SIDE BRANCH. AS WITH ANY TYPE OF VASCULAR IMPLANT, INFECTION, SECONDARY TO CONTAMINATION OF THE STENT, MAY LEAD TO THROMBOSIS, PSEUDOANEURYSM OR RUPTURE INTO A NEIGHBORING ORGAN OR THE RETROPERITONEUM. THE STENT MAY CAUSE A THROMBUS, DISTAL EMBOLIZATION OR MAY MIGRATE FROM THE SITE OF THE IMPLANT DOWN THE ARTERIAL LUMEN. OVERSTRETCHING OF THE ARTERY MAY RESULT IN RUPTURE AND LIFE-THREATENING BLEEDING.¿ PROCEDURES REQUIRING PERCUTANEOUS CATHETER INTRODUCTION SHOULD NOT BE ATTEMPTED BY PHYSICIANS UNFAMILIAR WITH THE POSSIBLE COMPLICATIONS. COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POTENTIAL COMPLICATIONS MAY INCLUDE, BUT ARE NOT LIMITED TO: AMPUTATION, ANEURYSM AND PSEUDOANEURYSM FORMATION, ARRHYTHMIA, ARTERIOVENOUS FISTULA, BLUE TOE SYNDROME, CORONARY ISCHEMIA, DEATH, DISSEMINATED INTRAVASCULAR COAGULATION, DRUG REACTIONS, ALLERGIC REACTION TO CONTRAST MEDIUM OR TO THE IMPLANTED DEVICE, EMBOLISM, EMERGENCY ARTERY BYPASS GRAFT SURGERY, G.I. BLEEDING FROM ANTICOAGULATION/ANTIPLATELET MEDICATION, HEMATOMA, HEMOBILIA, HEMORRHAGE, HEMORRHAGIC OR EMBOLIC STROKE/ TIA, ILIAC ARTERY SPASM, INTIMAL TEAR/DISSECTION, PNEUMOTHORAX, RENAL FAILURE, RESPIRATORY ARREST, SEPSIS/INFECTION, STENT MIGRATION/EMBOLIZATION, STENT MISPLACEMENT, THROMBOSIS, TISSUE NECROSIS, VASCULAR INJURY, INCLUDING PERFORATION, RUPTURE AND DISSECTION, VESSEL OCCLUSION, AND RESTENOSIS.¿ BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.
ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, APPROXIMATELY 15 MONTHS AFTER A 6X150 NON-CORDIS STENT WAS IMPLANTED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND A 6X150MM SMART CONTROL SELF-EXPANDING STENT (SES) WAS PLACED IN THE PROXIMAL SFA. THE DISTAL PORTION HAD A STENOSIS, AND THE PROXIMAL PORTION HAD A CHRONIC TOTAL OCCLUSION (CTO). THE PREOPERATIVE CT SCAN FOR CANCER AT THE GASTROINTESTINAL SURGERY DEPARTMENT REVEALED A PSEUDOANEURYSM AT THE STENT SITE. AS A RESULT, A PROCEDURE WAS PERFORMED. A PSEUDOANEURYSM MEASURING APPROXIMATELY 5 MM WAS FOUND AT THE SITE OF THE SMART CONTROL STENT PLACEMENT AND WAS SURGICALLY REMOVED. SINCE THE AREA WHERE THE PSEUDOANEURYSM WAS FOUND HAD NO INTIMAL COVERING AND THE STENT WAS EXPOSED, THE STENT WAS REMOVED AND CONNECTED TO AN ARTIFICIAL BLOOD VESSEL, AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAD NO CURRENT SYMPTOMS, BUT IT WAS LATER DISCOVERED THAT HE HAD EXPERIENCED SWELLING IN HIS THIGH IMMEDIATELY AFTER EVT. AN UNKNOWN STENT WAS PLACED WHERE THE UNKNOWN WIRE PASSED THROUGH THE FALSE LUMEN DURING THE EVT. THE CINE-IMAGE AFTER THE EVT SHOWED BLOOD LEAKING OUT OF THE BLOOD VESSEL, SO THE DOCTOR COMMENTED THAT THIS MAY HAVE BEEN THE CAUSE OF THE ANEURYSM. THE LEAK IN THE VESSEL WAS RESOLVED. THE PSEUDOANEURYSM WAS NOT REMOVED. THE PATIENT IS NOTED TO BE IN GOOD STATUS.
AS REPORTED, APPROXIMATELY 15 MONTHS AFTER A 6X150 NON-CORDIS STENT WAS IMPLANTED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND A 6X150MM SMART CONTROL SELF-EXPANDING STENT (SES) WAS PLACED IN THE PROXIMAL SFA. THE DISTAL PORTION HAD A STENOSIS, AND THE PROXIMAL PORTION HAD A CHRONIC TOTAL OCCLUSION (CTO). THE PREOPERATIVE CT SCAN FOR CANCER AT THE GASTROINTESTINAL SURGERY DEPARTMENT REVEALED A PSEUDOANEURYSM AT THE STENT SITE. AS A RESULT, A PROCEDURE WAS PERFORMED. A PSEUDOANEURYSM MEASURING APPROXIMATELY 5 MM WAS FOUND AT THE SITE OF THE SMART CONTROL STENT PLACEMENT AND WAS SURGICALLY REMOVED. SINCE THE AREA WHERE THE PSEUDOANEURYSM WAS FOUND HAD NO INTIMAL COVERING AND THE STENT WAS EXPOSED, THE STENT WAS REMOVED AND CONNECTED TO AN ARTIFICIAL BLOOD VESSEL, AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAD NO CURRENT SYMPTOMS, BUT IT WAS LATER DISCOVERED THAT HE HAD EXPERIENCED SWELLING IN HIS THIGH IMMEDIATELY AFTER EVT. AN UNKNOWN STENT WAS PLACED WHERE THE UNKNOWN WIRE PASSED THROUGH THE FALSE LUMEN DURING THE EVT. THE CINE-IMAGE AFTER THE EVT SHOWED BLOOD LEAKING OUT OF THE BLOOD VESSEL, SO THE DOCTOR COMMENTED THAT THIS MAY HAVE BEEN THE CAUSE OF THE ANEURYSM. THE LEAK IN THE VESSEL WAS RESOLVED. THE PSEUDOANEURYSM WAS NOT REMOVED. THE PATIENT IS NOTED TO BE IN GOOD STATUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 906789 | SMART CONTROL | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | CORDIS US. CORP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Life Threatening| O | LIFE STENT (6-150). |