BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S.M.A.R.T. NITINOL STENT SYSTEM

    MDR report key: 2020203 · Received March 16, 2011

    Report

    Report Number
    9616099-2011-00184
    Event Type
    Injury
    Date Received
    March 16, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT WAS MADE TO STOP THE BLEEDING THROUGH USE OF SUTURES AND A CLAMP BELOW THE RENAL ARTERIES. THESE ATTEMPTS WERE NOT SUCCESSFUL AND THE PATIENT DIED. IT WAS OBSERVED THAT THE AORTA HAD BEEN PERFORATED IN SEVERAL PLACES (STARTING AT THE BIFURCATION UP TO THE LEVEL OF THE RENAL ARTERIES). THE BALLOON CATHETER HAD PROBABLY KINKED. THE LESION WAS VERY CALCIFIED. THERE WAS LIMITED VESSEL TORTUOSITY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WERE NO ANOMALIES NOTED ON THE PRODUCT PRIOR TO USE IN THE PATIENT. THE DEVICE WAS INSERTED THROUGH A REGULAR SHEATH WITH HEMOSTATIC VALVE. MINIMAL RESISTANCE WAS MET WHILE ADVANCING THE DEVICE. EXCESSIVE TORQUING WAS NOT REQUIRED. MINIMAL RESISTANCE WAS MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE PRODUCT WILL BE RETURNED FOR EVALUATION. PLEASE NOTE THE CATALOG NUMBER IS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION INDICATED THAT THE PATIENT WHO HAD AN EARLIER PROCEDURE FOR SMART STENT DEPLOYMENT IN THE SFA (WAS NOTED OCCLUDED AFTER APPROXIMATELY 1 YR) WAS ADMITTED SOME TIME LATER WITH A RED FOOT (ISCHEMIC - INFECTED) AND UNDERWENT THROMBOLYSIS FOR THE NEXT 20 HOURS. ACCESS WAS THROUGH LEFT GROIN (CROSS-OVER TECHNIQUE). THE NEXT DAY ANGIOGRAPHIC IMAGE OF RIGHT LEG REVEALED THE FEM-POP BYPASS WAS OPEN, BUT THERE WAS SUB-OPTIMAL OUTFLOW AND THE PHYSICIAN DECIDED TO DILATE THE TIBIAL PERONEAL TRUNK. A SLEEK RX PTA CATHETER WAS INSERTED OVER THE 0.014" (BSC) GUIDEWIRE. THE PHYSICIAN FELT MINIMAL RESISTANCE WHILE INSERTING THE BALLOON. AT THIS TIME, THE PATIENT COMPLAINED OF A SHARP PAIN IN THE BACK. THE C-ARM WAS MOVED CRANIALLY TO VIEW THE AORTA-ILIAC BIFURCATION. THE OBSERVATION WAS MADE THAT THE SLEEK CATHETER HAD BROKEN INTO 2 PIECES AT THE TRANSITION POINT BETWEEN THE "OVER-THE-WIRE" AND THE "RAPID EXCHANGE" PART: THE DISTAL PART WAS LOCATED APPROXIMATELY 10CM BELOW THE GROIN IN THE RIGHT LEG; THE PROXIMAL PART WAS LOCATED INSIDE THE AORTA. A "SNARE" WAS INSERTED TWICE TO RETRIEVE THE PROXIMAL PART OF THE CATHETER, BUT WAS NOT SUCCESSFUL. AN ABBOTT STARCLOSE CLOSURE DEVICE WAS USED (OVER THE TERUMO GUIDEWIRE) - NO BLEEDING WAS SEEN AT THE TIME OF CLOSURE. PATIENT WAS STILL COMPLAINING OF BACK PAIN AND WAS GIVEN PAIN MEDICATION BY THE ANESTHESIOLOGIST AND WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT. A FEW HOURS LATER, THE PATIENT WENT INTO SHOCK AND A LAPAROTOMY WAS PERFORMED. WHEN OPENING UP THE RETROPERITONEAL CAVITY, BLEEDING WAS NOTICED AT THE LEVEL OF THE AORTA-ILIAC BIFURCATION. AN ATTEMPT WAS MADE TO STOP THE BLEEDING THROUGH USE OF SUTURES AND A CLAMP BELOW THE RENAL ARTERIES. THESE ATTEMPTS WERE NOT SUCCESSFUL AND THE PATIENT EXPIRED. IT WAS OBSERVED THAT THE AORTA HAD BEEN PERFORATED IN SEVERAL PLACES (STARTING AT THE BIFURCATION UP TO THE LEVEL OF THE RENAL ARTERIES). THE BALLOON CATHETER HAD PROBABLY KINKED. THE LESION WAS VERY CALCIFIED WITH LIMITED VESSEL TORTUOSITY. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WERE NO ANOMALIES NOTED ON THE PRODUCT PRIOR TO USE IN THE PATIENT. THE DEVICE WAS INSERTED THROUGH A REGULAR SHEATH WITH HEMOSTATIC VALVE. MINIMAL RESISTANCE WAS MET WHILE ADVANCING THE DEVICE. EXCESSIVE TORQUING WAS NOT REQUIRED. MINIMAL RESISTANCE WAS MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE PATIENT'S MEDICAL HISTORY INCLUDED VENOUS INSUFFICIENCY, DIABETES MELLITUS (TYPE II), HISTORY OF SMOKING (QUIT 15 YEARS AGO), DOES NOT TAKE OPTIMAL CARE OF HERSELF AND HAD A RIGHT FEMORAL-POPLITEAL BYPASS (BELOW THE KNEE) 1.5 YEARS AGO. (B)(4): THE SMART STENT REMAINS IMPLANTED IN THE PATIENT AND WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. ISR IS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION.

    Description of Event or Problem · 1

    THE INFORMATION INDICATED THAT THE PATIENT HAD PROCEDURE FOR SMART STENT DEPLOYMENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA) THAT OCCLUDED APPROXIMATELY A YEAR LATER, WAS ADMITTED SOME TIME LATER WITH A RED FOOT (ISCHEMIC - INFECTED) AND UNDERWENT THROMBOLYSIS FOR THE NEXT 20 HRS. ACCESS WAS THROUGH LEFT GROIN (CROSS-OVER TECHNIQUE). THE NEXT DAY ANGIOGRAPHIC IMAGE OF RIGHT LEG REVEALED THE FEM-POP BYPASS WAS OPEN, BUT THERE WAS SUB-OPTIMAL OUTFLOW AND THE PHYSICIAN DECIDED TO DILATE THE TRUNCUS TIBIALIS PERINEALIS. A SLEEK RX PTA CATHETER WAS INSERTED OVER THE 0.014" (BSC) GUIDEWIRE. THE PHYSICIAN FELT MINIMAL RESISTANCE WHILE INSERTING THE BALLOON. AT THIS TIME, THE PATIENT COMPLAINED OF A SHARP PAIN IN THE BACK. THE C-ARM WAS MOVED CRANIALLY TO VIEW THE AORTA-ILIAC BIFURCATION. THE OBSERVATION WAS MADE THAT THE SLEEK CATHETER HAD BROKEN INTO 2 PIECES AT THE TRANSITION POINT BETWEEN THE "OVER-THE-WIRE" AND THE "RAPID EXCHANGE" PART: THE DISTAL PART WAS LOCATED APPROXIMATELY 10CM BELOW THE GROIN IN THE RIGHT LEG, THE PROXIMAL PART WAS LOCATED INSIDE THE AORTA. A "SNARE" WAS INSERTED TWICE TO RETRIEVE THE PROXIMAL PART OF THE CATHETER, BUT WERE NOT SUCCESSFUL. AN ABBOTT STARCLOSE CLOSURE DEVICE WAS USED (OVER THE TERUMO GUIDEWIRE) - NO BLEEDING WAS SEEN AT THE TIME OF CLOSURE. PATIENT WAS STILL COMPLAINING OF BACK PAIN AND WAS GIVEN PAIN MEDICATION BY THE ANESTHESIOLOGIST. PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT. A FEW HRS LATER, THE PATIENT WENT INTO SHOCK AND THE PHYSICIAN WAS CALLED BACK TO THE PATIENT (LAPARATOMY HAD BEEN STARTED BY THE SURGEON ON DUTY). WHEN OPENING UP THE RETROPERITONEAL CAVITY, A BLEEDING WAS NOTICED AT THE LEVEL OF THE AORTA-ILIAC BIFURCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S.M.A.R.T. NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R