CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00157
- Event Type
- Injury
- Date Received
- April 5, 2011
- Date of Event
- March 6, 2012
- Report Date
- June 13, 2012
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THROMBUS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. DISCONTINUATION OF ANTIPLATELET THERAPY MAY CAUSE THROMBUS FORMATION. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR THROMBOTIC EVENTS INCLUDE THOSE WITH LONG LESIONS, A VESSEL DIAMETER LESS THAN 3MM AND PREVIOUS THROMBUS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE POSSIBLE RISK FACTORS PRESENT IN THE PATIENT'S MEDICAL HISTORY, SUCH AS SMOKING, AND VESSEL FACTORS (2.25MM VESSEL DIAMETER) THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.
THE CODE FOR THROMBOSIS SHOULD BE DELETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE REPORT IS FROM (B)(4) STUDY. THE INDICATION FOR THE INTERVENTION WAS STABLE ANGINA PECTORIS. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERTENSION, HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF PERIPHERAL ARTERY DISEASE, HISTORY OF PREVIOUS PCI, HISTORY OF PVD/CLAUDICATION, HISTORY OF DIABETES MELLITUS (TYPE II CONTROLLED WITH ORAL ANTIDIABETICS AND DIET), HISTORY OF RENAL INSUFFICIENCY, HISTORY OF ALLERGY (CODEINE AND DERIVATIVES; ALBUTEROL AND BROCHOLODILATOR AGENTS). THE TARGET LESION WAS 3RD OM. VESSEL DIAMETER WAS 2.25MM AND LESION LENGTH WAS 10MM. LESION CLASSIFICATION WAS A. THE LESION WAS DE NOVO AND 90% STENOSED. THE LESION WAS PRE-DILATED WITH A 2 X 12MM BALLOON AT 12ATM. THE STENT FAILED TO DELIVER THE FIRST ATTEMPT. IT WAS WITHDRAWN AND RETURNED TO THE STERILE FIELD. THE LESION WAS PRE-DILATED AND THE (B)(4) WAS DEPLOYED AT 16ATM. POST-PROCEDURE STENOSIS WAS 0%. APPROXIMATELY 10 MONTHS POST-PROCEDURE, THE PATIENT HAD STENT THROMBOSIS OF THE STENTED SEGMENT. THE THROMBOSIS WAS MEDICALLY MANAGED ONLY. THREE WEEKS LATER, THE PATIENT HAD A RIGHT BRACHIAL HEMATOMA POST-ANGIO. THE HEMATOMA WAS TREATED WITH ICE AND MANUAL PRESSURE. ADDITIONAL INFORMATION INDICATES THAT THE FIRST SHEATH USED TO ACCESS THE RIGHT BRACHIAL ARTERY WAS A CORDIS J&J 6.5FR X 11CM. THIS SHEATH WAS IMMEDIATELY EXCHANGED FOR A SCIMED PINNACLE INTRO 6FR SHEATH. THE CARDIAC CATHETERIZATION CONTROL LOG REPORTS, "THIS SHEATH EXCHANGE WAS NECESSARY IN ORDER TO ACHIEVE VASCULAR HEMOSTASIS." THE PATIENT ALSO REPORTED STABLE ANGINA AT THE 12 MONTH FOLLOW-UP. THE ADJUDICATION COMMITTEE NOTED THAT THERE WAS A SMALL PSEUDOANEURYSM THAT DID NOT REQUIRE TREATMENT. THE ADJUDICATION ALSO INDICATES THE STUDY STENT IN THE OM3 WAS TYPE 4 INSTENT RESTENOSIS PATTERN. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. DISCONTINUATION OF ANTIPLATELET THERAPY MAY CAUSE THROMBUS FORMATION. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS (SPECIFICALLY DIABETES) AND VESSEL/LESION FACTORS (SMALL DIAMETER) THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.
(B)(4). UPDATED COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED A PERI-PROCEDURAL MI, APPROXIMATELY TEN MONTHS POST PROCEDURE, SUFFERED RESTENOSIS, AND APPROXIMATELY 2 YEARS POST INDEX THE PATIENT DIED. THE INDICATION FOR THE INTERVENTION WAS STABLE ANGINA PECTORIS. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERTENSION, HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, PERIPHERAL ARTERY DISEASE, HISTORY OF PREVIOUS PCI, PVD/CLAUDICATION, DIABETES MELLITUS (TYPE II CONTROLLED WITH ORAL ANTIDIABETICS AND DIET), RENAL INSUFFICIENCY, AND ALLERGY TO CODEINE AND DERIVATIVES, ALBUTEROL AND BROCHOLODILATOR AGENTS. THE TARGET LESION WAS 3RD OM. VESSEL DIAMETER WAS 2.25MM AND LESION LENGTH WAS 10MM. LESION CLASSIFICATION WAS A. THE LESION WAS DE NOVO AND 90% STENOSED. THE LESION WAS PRE-DILATED WITH A 2 X 12MM BALLOON AT 12ATM. THE STENT FAILED TO DELIVER THE FIRST ATTEMPT. IT WAS WITHDRAWN AND RETURNED TO THE STERILE FIELD. THE LESION WAS PRE-DILATED AND THE (B)(4) WAS DEPLOYED AT 16ATM. POST-PROCEDURE STENOSIS WAS 0%. POST PROCEDURE THERE WERE ELEVATED CK AND TROPONIN LEVELS THAT WERE ADJUDICATED AS AN ARC EVENT AND ARE BEING CAPTURED AS AN MI. THERE WAS NO SPECIFIC TREATMENT GIVEN AND THE PATIENT WAS DISCHARGED ON DUAL ANTI-PLATELET THERAPY. APPROXIMATELY (B)(6) POST-PROCEDURE, THE PATIENT HAD STENT RESTENOSIS. THE EVENT WAS MEDICALLY MANAGED ONLY. THREE WEEKS LATER, THE PATIENT HAD A RIGHT BRACHIAL HEMATOMA POST-ANGIO. THE HEMATOMA WAS TREATED WITH ICE AND MANUAL PRESSURE. ADDITIONAL INFORMATION INDICATES THAT THE FIRST SHEATH USED TO ACCESS THE RIGHT BRACHIAL ARTERY WAS A CORDIS J&J 6.5FR X 11CM. THIS SHEATH WAS IMMEDIATELY EXCHANGED FOR A SCIMED PINNACLE INTRO 6FR SHEATH. THE CARDIAC CATHETERIZATION CONTROL LOG REPORTS, "THIS SHEATH EXCHANGE WAS NECESSARY IN ORDER TO ACHIEVE VASCULAR HEMOSTASIS." THE PATIENT ALSO REPORTED STABLE ANGINA AT THE 12 MONTH FOLLOW-UP. THE ADJUDICATION COMMITTEE NOTED THAT THERE WAS A SMALL PSEUDOANEURYSM THAT DID NOT REQUIRE TREATMENT. THE ADJUDICATION ALSO INDICATES THE STUDY STENT IN THE OM3 WAS TYPE 4 INSTENT RESTENOSIS PATTERN. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT APPROXIMATELY TWO YEARS POST INDEX PROCEDURE THE PATIENT HAD DIED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PNEUMONIA, A CARDIAC ARREST IN THE NURSING HOME, AND EXPIRED. THE DEATH OCCURRED APPROXIMATELY TWO YEARS AFTER THE INDEX PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE MULTIPLE ATTEMPTS. THE STUDY STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15088658 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MI IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THROMBOTIC OR RESTENOSIS EVENTS WHEREIN THE INNER LUMEN OF THE CORONARY ARTERY BECOMES NARROWED AND BLOOD FLOW DECREASED. THE MYOCARDIAL TISSUES ARE STARVED OF OXYGEN AND OTHER NUTRIENTS SECONDARY TO THE DECREASED OR STOPPED BLOOD FLOW AND IT CAUSES PERMANENT CARDIAC DAMAGE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM (B)(4) 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. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. DEATH, FROM CARDIAC ARREST, IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH.
ADDENDUM: CEC ADJUDICATION MINUTES RECEIVED INDICATED THAT THE PATIENT SUFFERED MI APPROXIMATELY (B)(6) MONTHS POST INDEX PROCEDURE. AS PER THE ADJUDICATION REPORT, ON (B)(6) 2012 AT 16:15, THE TROPONIN I WAS 0.52 (0.03 UNL). ON (B)(6) 2012 AT 23:00, THE TROPONIN I WAS 0.47, AND ON (B)(6) 2012, THE TROPONIN I WAS 0.33. ACCORDING TO THE ER PHYSICIAN'S NOTE, THE INITIAL ECG SHOWED "SOMEWHAT IRREGULAR RHYTHM" WITH PACED BEATS AND NON-SPECIFIC ST SEGMENT CHANGES; AND A REPEAT ECG SHOWED NORMAL SINUS RHYTHM AND NON-SPECIFIC ST SEGMENT CHANGES. THE ECG CORE LAB REPORTED PERSISTENT AV SEQUENTIAL PACING AND UNINTERPRETABLE MI DUE TO PACED RHYTHM. THE ELEVATED TROPONIN I WAS LATER DIAGNOSED AS AN MI BASED ON THE RECEIVED ADJUDICATION MINUTES. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED A PERI-PROCEDURAL MI, APPROXIMATELY (B)(6) MONTHS POST PROCEDURE SUFFERED RESTENOSIS AND APPROXIMATELY (B)(6) YEARS POST INDEX THE PATIENT SUFFERED AN MI AND THEN DIED. THE INDICATION FOR THE INTERVENTION WAS STABLE ANGINA PECTORIS. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERTENSION, HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF PERIPHERAL ARTERY DISEASE, HISTORY OF PREVIOUS PCI, HISTORY OF PVD/CLAUDICATION, HISTORY OF DIABETES MELLITUS (TYPE II CONTROLLED WITH ORAL ANTIDIABETICS AND DIET), HISTORY OF RENAL INSUFFICIENCY, HISTORY OF ALLERGY (CODEINE AND DERIVATIVES; ALBUTEROL AND BRONCHODILATOR AGENTS). THE TARGET LESION WAS 3RD OM. VESSEL DIAMETER WAS 2.25 MM AND LESION LENGTH WAS 10 MM. LESION CLASSIFICATION WAS A. THE LESION WAS DE NOVO AND 90% STENOSED. THE LESION WAS PRE-DILATED WITH A 2 X 12 MM BALLOON AT 12 ATM. THE STENT FAILED TO DELIVER THE FIRST ATTEMPT. IT WAS WITHDRAWN AND RETURNED TO THE STERILE FIELD. THE LESION WAS PRE-DILATED AND THE (B)(4) WAS DEPLOYED AT 16 ATM. POST-PROCEDURE STENOSIS WAS 0%. POST PROCEDURE THERE WERE ELEVATED CK AND TROPONIN LEVELS THAT WERE ADJUDICATED AS AN ARC EVENT AND ARE BEING CAPTURED AS AN MI. THERE WAS NO SPECIFIC TREATMENT GIVEN AND THE PATIENT WAS DISCHARGED ON DUAL ANTI-PLATELET THERAPY. APPROXIMATELY (B)(6) MONTHS POST-PROCEDURE, THE PATIENT HAD STENT RESTENOSIS. THE EVENT WAS MEDICALLY MANAGED ONLY. (B)(6) WEEKS LATER, THE PATIENT HAD A RIGHT BRACHIAL HEMATOMA POST-ANGIO. THE HEMATOMA WAS TREATED WITH ICE AND MANUAL PRESSURE. ADDITIONAL INFORMATION INDICATES THAT THE FIRST SHEATH USED TO ACCESS THE RIGHT BRACHIAL ARTERY WAS A CORDIS J&J 6.5 FR X 11 CM. THIS SHEATH WAS IMMEDIATELY EXCHANGED FOR A SCIMED PINNACLE INTRO 6FR SHEATH. THE CARDIAC CATHETERIZATION CONTROL LOG REPORTS, "THIS SHEATH EXCHANGE WAS NECESSARY IN ORDER TO ACHIEVE VASCULAR HEMOSTASIS". THE PATIENT ALSO REPORTED STABLE ANGINA AT THE 12 MONTH FOLLOW-UP. THE ADJUDICATION COMMITTEE NOTED THAT THERE WAS A SMALL PSEUDOANEURYSM THAT DID NOT REQUIRE TREATMENT. THE ADJUDICATION ALSO INDICATES THE STUDY STENT IN THE OM3 WAS TYPE 4 INSTENT RESTENOSIS PATTERN. APPROXIMATELY TWO YEARS POST PROCEDURE, THE PATIENT DEVELOPED SHORTNESS OF BREATH, WHILE RESIDING IN A NURSING HOME. SHE BECAME UNRESPONSIVE, EMS WAS CALLED TO THE SCENE AND ACLS RESUSCITATIVE EFFORTS WERE INITIATED. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AFTER SUCCESSFUL RESUMPTION OF A PULSE; HOWEVER, REMAINED UNRESPONSIVE. THE INITIAL CK WAS 24, THE CKMB WAS 0.9 AND THE TROPONIN WAS 0.03. LATER THE TROPONIN PEAKED AT 0.52; THE CK AND CKMB WERE NOT TESTED. THIS ENZYME ELEVATION EVENT HAS BEEN DEEMED BY THE CEC COMMITTEE TO BE AN ARC (SPONTANEOUS), THUS THE FILE WAS CODED FOR MI. ACCORDING TO THE ER PHYSICIAN, THE ECG SHOWED SOMEWHAT IRREGULAR RHYTHM WITH PACED BEATS AND NON-SPECIFIC ST SEGMENT CHANGES. THE ECG LAB REPORTED PERSISTENT AV SEQUENTIAL PACING AND UNINTERPRETABLE MI DUE TO PACED RHYTHM. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT APPROXIMATELY (B)(6) WEEKS POST MI, THE PATIENT HAD DIED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PNEUMONIA, A CARDIAC ARREST IN THE NURSING HOME, AND EXPIRED. THE DEATH OCCURRED APPROXIMATELY TWO YEARS AFTER THE INDEX PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE MULTIPLE ATTEMPTS. THE STUDY STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15088658 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MI IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THROMBOTIC OR RESTENOSIS EVENTS WHEREIN THE INNER LUMEN OF THE CORONARY ARTERY BECOMES NARROWED AND BLOOD FLOW DECREASED. THE MYOCARDIAL TISSUES ARE STARVED OF OXYGEN AND OTHER NUTRIENTS SECONDARY TO THE DECREASED OR STOPPED BLOOD FLOW AND IT CAUSES PERMANENT CARDIAC DAMAGE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. 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. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. DEATH, FROM CARDIAC ARREST, IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH.
PLEASE NOTE ADDITIONAL INFORMATION RECEIVED ON 8/2/2011. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
UPDATED COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED A PERI-PROCEDURAL MI AND APPROXIMATELY TEN MONTHS POST PROCEDURE SUFFERED RESTENOSIS. THE INDICATION FOR THE INTERVENTION WAS STABLE ANGINA PECTORIS. THE PATIENT'S MEDICAL HISTORY INCLUDES HYPERTENSION, HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HISTORY OF PERIPHERAL ARTERY DISEASE, HISTORY OF PREVIOUS PCI, HISTORY OF PVD/CLAUDICATION, HISTORY OF DIABETES MELLITUS (TYPE II CONTROLLED WITH ORAL ANTIDIABETICS AND DIET), HISTORY OF RENAL INSUFFICIENCY, HISTORY OF ALLERGY (CODEINE AND DERIVATIVES; ALBUTEROL AND BROCHOLODILATOR AGENTS). THE TARGET LESION WAS 3RD OM. VESSEL DIAMETER WAS 2.25MM AND LESION LENGTH WAS 10MM. LESION CLASSIFICATION WAS A. THE LESION WAS DE NOVO AND 90% STENOSED. THE LESION WAS PRE-DILATED WITH A 2 X 12MM BALLOON AT 12ATM. THE STENT FAILED TO DELIVER THE FIRST ATTEMPT. IT WAS WITHDRAWN AND RETURNED TO THE STERILE FIELD. THE LESION WAS PRE-DILATED AND THE (B)(4) WAS DEPLOYED AT 16ATM. POST-PROCEDURE STENOSIS WAS 0%. POST PROCEDURE THERE WERE ELEVATED CK AND TROPONIN LEVELS THAT WERE ADJUDICATED AS AN ARC EVENT AND ARE BEING CAPTURED AS AN MI. THERE WAS NO SPECIFIC TREATMENT GIVEN AND THE PATIENT WAS DISCHARGED ON DUAL ANTI-PLATELET THERAPY. APPROXIMATELY 10 MONTHS POST-PROCEDURE, THE PATIENT HAD STENT RESTENOSIS. THE EVENT WAS MEDICALLY MANAGED ONLY. THE ADJUDICATION INDICATED THE STUDY STENT IN THE OM3 WAS TYPE 4 INSTENT RESTENOSIS PATTERN. THE DEVICE REMAINED IMPLANTED AND WAS, THEREFORE, NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. MI IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THROMBOTIC OR RESTENOSIS EVENTS WHEREIN THE INNER LUMEN OF THE CORONARY ARTERY BECOMES NARROWED AND BLOOD FLOW DECREASED. THE MYOCARDIAL TISSUES ARE STARVED OF OXYGEN AND OTHER NUTRIENTS SECONDARY TO THE DECREASED OR STOPPED BLOOD FLOW AND IT CAUSES PERMANENT CARDIAC DAMAGE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. 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. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND DIABETES.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PNEUMONIA, AND THREE WEEKS LATER A CARDIAC ARREST IN THE NURSING HOME, AND EXPIRED. THE DEATH OCCURRED APPROXIMATELY TWO YEARS AFTER THE INDEX PROCEDURE. NO FURTHER INFORMATION COULD BE OBTAINED.
ADDITIONAL INFORMATION RECEIVED FROM THE CEC ADJUDICATION MINUTES ON 12/6/2011. THE COMMITTEE DETERMINED THAT THE PATIENT EXPERIENCED A PERI-PROCEDURE MI DURING THE INDEX PROCEDURE BASED ON THE PREVIOUSLY REPORTED TROPONIN I LEVEL OF 0.22 (ULN <0.01). THEY FURTHER REPORTED THAT THE POST-PROCEDURE COURSE WAS UNCOMPLICATED. THE SITE REPORTED THAT THERE WERE NO POST-PROCEDURE SYMPTOMS AND THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. IN ADDITION, THE MINUTES STATED THAT THE ANGIOGRAPHIC CORE LAB REPORTED A TOTALLY OCCLUDED 3RD OM STENT ON (B)(6) 2011 WITH NO EVIDENCE OF THROMBUS. THE PREVIOUSLY REPORTED CODE THROMBUS SHOULD BE DELETED AND THE CODE OF RESTENOSIS WILL REMAIN. THEY ALSO INDICATED THAT THERE WAS 99% IN-STENT RESTENOSIS WITH SLOW FLOW TO UNKNOWN STENTS IN THE RCA. THE SITE WAS UNABLE TO DETERMINE WHAT STENTS WERE PREVIOUSLY IMPLANTED. THE FINAL IMPRESSION AS NOTED IN THE CARDIAC CATHETERIZATION REPORT WAS THAT THE PATIENT'S RCA DISEASE WAS LIKELY RESPONSIBLE FOR HER ANGINA.
A (B)(6) FEMALE FROM THE (B)(4) STUDY EXPERIENCED A THROMBOTIC EVENT APPROXIMATELY ONE YEAR POST IMPLANTATION OF A CYPHER STENT. PAST MEDICAL HISTORY INCLUDED ANGINA, PREVIOUS PCI, PERIPHERAL ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, PVD/CLAUDICATION, DIABETES, RENAL INSUFFICIENCY, SMOKING, ALLERGY TO CODEINE AND DERIVATIVES, ALBUTEROL AND OTHER BRONCHODILATORS, AND A FAMILY HISTORY OF CORONARY ARTERY DISEASE. THE INDICATION FOR THE INTERVENTION WAS STABLE ANGINA PECTORIS. THE TARGET LESION WAS 3RD OM. THE VESSEL DIAMETER WAS 2.25MM AND LESION LENGTH WAS 10MM. THE LESION WAS DESCRIBED AS DE NOVO, 90% STENOSED AND TYPE A. THE LESION WAS PRE-DILATED WITH A 2 X 12MM BALLOON AT 12ATM. THE STENT FAILED TO BE DELIVERED ON THE FIRST ATTEMPT, SO IT WAS WITHDRAWN AND ADDITIONAL PRE-DILATION WAS CONDUCTED. A 2.25X13MM CYPHER WAS DEPLOYED AT 16ATM. POST-PROCEDURE STENOSIS WAS 0%. APPROXIMATELY FOURTEEN MONTHS POST INDEX PROCEDURE, THE PATIENT HAD AN ANGIOGRAM AND THROMBUS WAS VISUALIZED INSIDE THE CYPHER STENT IN THE 3RD OM. THE THROMBUS DID NOT CAUSE A MYOCARDIAL INFARCTION AND DID NOT REQUIRE REVASCULARIZATION. THE PATIENT WAS MEDICALLY MANAGED ONLY. THE PATIENT WAS REPORTED TO BE 80-100% COMPLIANT WITH THE ANTIPLATELET MEDICATION.
ADDITIONAL INFORMATION RECEIVED 8/2/2011: THE ADJUNCTION COMMITTEE NOTED THAT THERE WAS A SMALL PSEUDOANEURYSM THAT DID NOT REQUIRE TREATMENT ON (B)(6) 2011. THE ADJUDICATION ALSO INDICATES THE STUDY STENT IN THE OM3 WAS TYPE 4 IN STENT RESTENOSIS PATTERN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | 15088658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Death| L| R | ASPIRIN, CLOPIDOGREL |