SMART CONTROL NITINOL STENT SYSTEM
Report
- Report Number
- 9616099-2011-00361
- Event Type
- Injury
- Date Received
- May 24, 2011
- Date of Event
- April 25, 2011
- Report Date
- April 25, 2011
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- FGE
- PMA / PMN Number
- K021898
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
THE PATIENT WAS ADMITTED FOR ANGIOPLASTY OF A LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. HOWEVER, DURING THE PROCEDURE A DISSECTION OCCURRED NECESSITATING THE NEED FOR PLACEMENT OF TWO SMART CONTROL STENTS. APPROXIMATELY SEVEN MONTHS LATER, AN ADDITIONAL STENT WAS DEPLOYED FOR IN-STENT RESTENOSIS. IT IS NOT KNOWN IF ONE OR BOTH STENTS HAD RESTENOSED. PHYSICIAN'S COMMENT: THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, AND THE CAUSE OF THE EVENT WAS CONSIDERED TO BE DERIVED FROM THE UNDERLYING DISEASE. THE PATIENT'S MEDICAL HISTORY INCLUDES ABDOMINAL AORTIC ANEURYSM (BLOOD VESSEL PROSTHESIS IMPLANTATION), PERCUTANEOUS CORONARY INTERVENTION OF THE RIGHT CORONARY ARTERY, ARTERIOSCLEROTIC OBLITERATION (PRIMARY DISEASE), HYPERTENSION, HYPERLIPIDEMIA AND ANGINA. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE INVOLVED LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. 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. 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. 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. PLEASE NOTE THAT THIS IS ONE OF TWO PRODUCTS IMPLANTED DURING THE SAME PROCEDURAL SETTING. PLEASE REFERENCE MFR. REPORT #S 9616099-2011-00360 AND 9616099-2011-00361.
THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED IN-STENT RESTENOSIS OF THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS FOUND IN A (B)(6) MALE PATIENT APPROXIMATELY 7 MONTHS AFTER DEPLOYMENT OF 2 SMART CONTROL STENTS. ADDITIONALLY, APPROXIMATELY 2 YEARS AFTER THE INDEX PROCEDURE, IN STENT RESTENOSIS OCCURRED. AT THE TIME OF STUDY INCLUSION, THE PATIENT WAS ADMITTED FOR TREATMENT OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE STUDY WAS EXPLAINED, AND HIS CONSENT WAS OBTAINED. BASED ON THE ANGIOGRAPHY FINDINGS, THE PATIENT WAS JUDGED TO MEET THE STUDY CRITERIA. HE WAS ALLOCATED TO THE POBA GROUP, AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. HOWEVER, BAILOUT STENTING WAS PERFORMED ON THE PATIENT, DUE TO DISSECTION (UNKNOWN CAUSE), AND STUDY STENTS WERE PLACED. THE PROCEDURE WAS CONCLUDED UNEVENTFULLY. SUBSEQUENT ECHO OF THE TREATED ARTERY WERE NORMAL. ADDITIONAL ECHO PERFORMED REVEALED THE TREATED SEGMENT TO NOT BE DETECTABLE THROUGH THE STUDY STENT ON COLOR DOPPLER, AND BLOOD FLOW VELOCITY WAS IMMEASURABLE. SEVEN MONTHS AFTER THE INITIAL STENT DEPLOYMENTS, ADDITIONAL STENT PLACEMENT WAS PERFORMED ON RIGHT SUPERFICIAL FEMORAL ARTERY. THREE DAYS LATER, NO CLAUDICATION SYMPTOMS WERE NOTED, AND THE PATIENT WAS DISCHARGED IN RECOVERY CONDITION. THE PHYSICIAN COMMENTED THAT THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, AND THE CAUSE OF THE EVENT WAS CONSIDERED TO BE DERIVED FROM UNDERLYING DISEASE. HOWEVER I JUDGED IT WAS IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE BECAUSE THE RE-TREATED SEGMENT WAS SAME AS THE AREA OF THE STUDY DEVICES PLACEMENT. APPROXIMATELY 16 MONTHS LATER, THE PATIENT HAD BEEN APPETITE IMPAIRED AND GENERAL MALAISE. HE VISITED THE GASTROENTEROLOGICAL MEDICINE DEPARTMENT IN ANOTHER HOSPITAL BECAUSE THESE SYMPTOMS HAD BECOME GRADUALLY STRONGER. THE RESULT OF BLOOD TEST INDICATED THE SIGNIFICANT HYPONATRAEMIA (116 MEQ/L), AND HE WAS ADMITTED FOR FURTHER INVESTIGATION AND TREATMENT. ABDOMINAL ECHO AND CT WERE PERFORMED. NO MASS, ETC. WAS FOUND. THYROID FUNCTION AND ADRENAL FUNCTION WERE FREE OF AN ABNORMAL FINDING. HE HAD NOT BEEN ABLE TO HAVE A MEAL IN THE WEEKS BEFORE HE WAS ADMITTED TO THE HOSPITAL. CORRECTION OF SODIUM WAS PERFORMED WITH DRIP INFUSION. HIS APPETITE WAS GRADUALLY IMPROVED. APPROXIMATELY 1 YEAR LATER, INTERMITTENT CLAUDICATION OCCURRED IN THE RIGHT LEG. THE ABI WAS 0.69 ON THE RIGHT AND 1.02 ON THE LEFT. ONE MONTH LATER, THE PATIENT WAS ADMITTED TO HOSPITAL FOR VASCULAR TREATMENT OF RESTENOSIS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. POBA WAS PERFORMED FOR THE TREATMENT OF IN-STENT RESTENOSIS. THE PARTIAL INTIMAL FLAP IN THE STENT WAS IDENTIFIED; THEREFORE AN ADDITIONAL STENT WAS PLACED IN THE STENT. HE WAS DISCHARGED TO HOME IN GOOD CONDITION A FEW DAYS LATER. THE PHYSICIAN COMMENTED THAT THE PATIENT ORIGINALLY HAD ARTERIOSCLEROSIS OBLITERANS, WHICH WAS CONSIDERED TO BE THE CAUSE OF THIS EVENT. HOWEVER, THE RETREATED LESION WAS THE AREA WHERE STUDY DEVICE (STENT) WAS PLACED, THEREFORE, IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. ADDITIONALLY, THE PHYSICIAN¿S JUDGMENT INDICATED IT WAS IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. APPROXIMATELY 9 MONTHS LATER, THE PATIENT EXPERIENCED THE CHEST PAIN DURING PHYSICAL ACTIVITY, AND UNDERWENT CORONARY ANGIOGRAPHY. THE STENOSIS RATE WAS 75% IN RCA#1 (THE PROXIMAL PORTION OF STENT), 75% IN LAD#7, AND 50% IN LCX#13. THIS EVENT WAS JUDGED TO BE POSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE BECAUSE THE PATIENT ORIGINALLY HAD ANGINA AS AN UNDERLYING DISEASE, AND THE TREATED AREA WAS DIFFERENT FROM THE ONE WHERE THE STUDY DEVICE (STENT) WAS PLACED. THE PATIENT¿S MEDICAL HISTORY INCLUDED ABDOMINAL AORTIC ANEURYSM (BLOOD VESSEL PROSTHESIS IMPLANTATION), PERCUTANEOUS CORONARY INTERVENTION OF THE RIGHT CORONARY ARTERY, ARTERIOSCLEROTIC OBLITERATION (PRIMARY DISEASE), HYPERTENSION, HYPERLIPIDEMIA, ANGINA, ABDOMINAL AORTIC ANEURYSM, PROSTATIC CANCER, CONSTIPATION, BLEEDING PILES, NEUROGENIC BLADDER AND ARTERIOSCLEROTIC OBLITERATION (PRIMARY DISEASE). THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. 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. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. PLEASE NOTE THAT THIS IS ONE OF TWO PRODUCTS IMPLANTED DURING THE SAME PROCEDURAL SETTING. PLEASE REFERENCE MFR. REPORT #S 9616099-2011-00360 AND 9616099-2011-00361.
ADDITIONAL MEDICAL HISTORY INCLUDES ARTERIOSCLEROTIC OBLITERATION (PRIMARY DISEASE). ADDITIONAL INFORMATION WAS RECEIVED AS INDICATED BELOW FOR TWO NEW EVENTS, RESTENOSIS AND DEVICE INEFFECTIVE. NEW PATIENT CODE FOR RESTENOSIS (1985) AND DEVICE INEFFECTIVE, FOR WHICH A PATIENT CODE IS NOT AVAILABLE. NO UPDATES ARE REQUIRED TO THE DEVICE CODES. ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY 23 MONTHS AFTER STENT IMPLANTATION, THE PATIENT HAD INTERMITTENT CLAUDICATION OCCURRED IN THE RIGHT LEG. THE ABI WAS 0.69 ON THE RIGHT AND 1.02 ON THE LEFT. ONE MONTH LATER, THE PATIENT WAS ADMITTED TO HOSPITAL FOR VASCULAR TREATMENT OF RESTENOSIS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. ON THE FOLLOWING DAY, POBA WAS PERFORMED FOR THE TREATMENT OF IN-STENT RESTENOSIS. THE PARTIAL INTIMAL FLAP IN THE STENT WAS IDENTIFIED; THEREFORE AN ADDITIONAL STENT WAS PLACED IN THE STENT. HE WAS DISCHARGED HOME IN GOOD CONDITION TWO DAYS LATER. PHYSICIAN¿S COMMENT: THE PATIENT ORIGINALLY HAD ARTERIOSCLEROSIS OBLITERANS, WHICH WAS CONSIDERED TO BE THE CAUSE OF THIS EVENT. HOWEVER, THE RETREATED LESION WAS THE AREA WHERE STUDY DEVICE (STENT) WAS PLACED, THEREFORE, IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. THE PHYSICIAN¿S JUDGMENT: IT WAS JUDGED TO BE IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE. PLEASE NOTE THAT THIS IS ONE OF TWO PRODUCTS IMPLANTED DURING THE SAME PROCEDURAL SETTING. PLEASE REFERENCE MFR. REPORT #S 9616099-2011-00360 AND 9616099-2011-00361. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
IN-STENT RESTENOSIS; RIGHT SUPERFICIAL FEMORAL ARTERY. THIS COMPLAINT IS FROM THE (B)(4)STUDY IN (B)(4): ON (B)(6) 2010, THE PATIENT WAS ADMITTED FOR TREATMENT OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE STUDY WAS EXPLAINED, AND HIS CONSENT WAS OBTAINED. ON (B)(6) 2010, BASED ON THE ANGIOGRAPHY FINDINGS, THE PATIENT WAS JUDGED TO MEET THE STUDY CRITERIA. HE WAS ALLOCATED TO THE POBA GROUP, AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED. HOWEVER, BAILOUT STENTING WAS PERFORMED ON THE PATIENT, DUE TO DISSECTION (UNKNOWN CAUSE), AND STUDY STENTS WERE PLACED. THE PROCEDURE WAS CONCLUDED UNEVENTFULLY. ON (B)(6) 2010, AN ECHO OF THE TREATED ARTERY WAS NORMAL. ON (B)(6) 2010, (B)(6) 2011, LOWER EXTREMITY ARTERIAL ECHOS WERE PERFORMED, EACH OF WHICH REVEALED THE TREATED SEGMENT TO NOT BE DETECTABLE THROUGH THE STUDY STENT ON COLOR DOPPLER, AND BLOOD FLOW VELOCITY WAS UNMEASURABLE. ON (B)(6) 2011, STENT PLACEMENT WAS PERFORMED ON RIGHT SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2011, NO CLAUDICATION SYMPTOMS WERE NOTED, AND THE PATIENT WAS DISCHARGED IN RECOVERY CONDITION. PHYSICIAN'S COMMENT: THE PATIENT HAD ARTERIOSCLEROTIC OBLITERATION AS AN UNDERLYING DISEASE, AND THE CAUSE OF THE EVENT WAS CONSIDERED TO BE DERIVED FROM UNDERLYING DISEASE. HOWEVER I JUDGED IT WAS IMPOSSIBLE TO RULE OUT A CAUSAL RELATION TO THE STUDY DEVICE BECAUSE THE RE-TREATED SEGMENT WAS SAME AS THE AREA OF THE STUDY DEVICES PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART CONTROL NITINOL STENT SYSTEM | SELF EXPANDING STENTS (FGE) | FGE | CORDIS DE MEXICO | NA | 15106798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Hospitalization| R | JACKAL AND SAVVY PRE-DILATATION BALLOONS |