CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00472
- Event Type
- Death
- Date Received
- December 20, 2010
- Date of Event
- November 20, 2010
- Report Date
- November 23, 2010
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
A (B)(6) FROM THE (B)(4) STUDY DIED APPROXIMATELY ONE YEAR POST IMPLANTATION OF THREE CYPHER STENTS. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED HIS RISK FOR MACE INCLUDED OBESITY, ISCHEMIA, PREVIOUS PCI, PERIPHERAL ARTERY DISEASE, HYPERLIPIDAEMIA, HYPERTENSION, CVA/STROKE, LVEF 40-50%, CONGESTIVE HEART FAILURE, PVD/CLAUDICATION, COPD, DIABETES, SMOKING, ALLERGY, AND A FAMILY HISTORY OF CORONARY ARTERY DISEASE. THE PATIENT HAD 3 CYPHER STENTS PLACED IN THE PROXIMAL TO MID LAD AND THE DISTAL RCA. THE MID LAD WAS 2.75MM IN DIAMETER AND 30MM IN LENGTH. THE LESION WAS DE NOVO AND A TYPE B2 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 70%. THE LESION WAS PRE-DILATED WITH A 3 X 20MM BALLOON AT 14ATM. A CYPHER RX 2.75 X 33MM STENT WAS DEPLOYED AT 18ATM. THE PROXIMAL LAD WAS 2.75MM IN DIAMETER AND 15MM IN LENGTH. THE LESION WAS DE NOVO AND A TYPE B2 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 95%. A CYPHER RX 2.75 X 13MM STENT WAS DEPLOYED AT 22ATM. THE DISTAL RCA WAS 4MM IN DIAMETER AND 20MM IN LENGTH. THE LESION WAS DE NOVO AND A B1 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 90%. THE LESION WAS PRE-DILATED WITH A 3 X 20MM BALLOON AT 14ATM. A CYPHER RX 3 X 23MM STENT WAS DEPLOYED AT 20ATM. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. THE LESION WAS POST-DILATED WITH A 4 X 20MM BALLOON AT 16ATM. 6 TO 12 HOURS POST PROCEDURE, THE CK-MB AND TROPONIN LEVELS WERE SLIGHTLY ELEVATED. THE PATIENT WAS DISCHARGED 3 DAYS POST PROCEDURE. MEDICATION THERAPY AT DISCHARGE INCLUDED ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS EXPERIENCING STABLE ANGINA AT THE 30 DAY FOLLOW-UP. APPROXIMATELY TEN MONTHS LATER THE PATIENT WAS TREATED FOR PNEUMONIA AND HAD A CVA WITH LEFT SIDED WEAKNESS. ANTIPLATELET THERAPY WAS DISCONTINUED DUE TO THE CVA. THE EVENT WAS MEDICALLY MANAGED ONLY AND RESOLVED WITHOUT SEQUELAE 11 DAYS LATER. IT WAS REPORTED THAT THE PATIENT DIED OF AN UNKNOWN CAUSE APPROXIMATELY THREE MONTHS LATER. THERE WAS NO OTHER INFORMATION AVAILABLE. 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. DEATH IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE CYPHER STENTS AND THIS PATIENT'S DEATH. HOWEVER, IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT KNOWN. REVIEW OF THE INFORMATION AVAILABLE SUGGESTS THAT THERE ARE PATIENT FACTORS (ADVANCED AGE AND CRITICAL MEDICAL HISTORY) THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S DEATH.
THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2010-00470 AND 3003742446-2010-00473. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A PERIPROCEDURAL MYOCARDIAL INFARCTION AND LATER DIED AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. A (B)(6) FROM THE (B)(4) STUDY DIED APPROXIMATELY ONE YEAR POST IMPLANTATION OF THREE CYPHER STENTS. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED HIS RISK FOR MACE INCLUDED OBESITY, ISCHEMIA, PREVIOUS PCI, PERIPHERAL ARTERY DISEASE, HYPERLIPIDAEMIA, HYPERTENSION, CVA/STROKE, LVEF 40-50%, CONGESTIVE HEART FAILURE, PVD/CLAUDICATION, COPD, DIABETES, SMOKING, ALLERGY, AND A FAMILY HISTORY OF CORONARY ARTERY DISEASE. THE PATIENT HAD 3 CYPHER STENTS PLACED IN THE PROXIMAL TO MID LAD AND THE DISTAL RCA. THE MID LAD WAS 2.75MM IN DIAMETER AND 30MM IN LENGTH. THE LESION WAS DE NOVO AND A TYPE B2 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 70%. THE LESION WAS PRE-DILATED WITH A 3 X 20MM BALLOON AT 14ATM. A CYPHER RX 2.75 X 33MM STENT WAS DEPLOYED AT 18ATM. THE PROXIMAL LAD WAS 2.75MM IN DIAMETER AND 15MM IN LENGTH. THE LESION WAS DE NOVO AND A TYPE B2 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 95%. A CYPHER RX 2.75 X 13MM STENT WAS DEPLOYED AT 22ATM. THE DISTAL RCA WAS 4MM IN DIAMETER AND 20MM IN LENGTH. THE LESION WAS DE NOVO AND A B1 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 90%. THE LESION WAS PRE-DILATED WITH A 3 X 20MM BALLOON AT 14ATM. A CYPHER RX 3 X 23MM STENT WAS DEPLOYED AT 20ATM. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. THE LESION WAS POST-DILATED WITH A 4 X 20MM BALLOON AT 16ATM. POST-PROCEDURE ON (B)(6) 2009 AT 04:21, THE CK WAS 101 (RATIO <1), THE CKMB WAS 4.5 (RATIO 1.18) AND THE TROPONIN I WAS 0.11 (RATIO 3.66). THE PATIENT WAS DISCHARGED 3 DAYS POST PROCEDURE. MEDICATION THERAPY AT DISCHARGE INCLUDED ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS EXPERIENCING STABLE ANGINA AT THE 30 DAY FOLLOW-UP. APPROXIMATELY TEN MONTHS LATER, THE PATIENT WAS TREATED FOR PNEUMONIA AND HAD A CVA WITH LEFT SIDED WEAKNESS. ANTIPLATELET THERAPY WAS DISCONTINUED DUE TO THE CVA. THE EVENT WAS MEDICALLY MANAGED ONLY AND RESOLVED WITHOUT SEQUELAE 11 DAYS LATER. IT WAS REPORTED THAT THE PATIENT DIED OF AN UNKNOWN CAUSE APPROXIMATELY THREE MONTHS LATER. THERE WAS NO OTHER INFORMATION AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT. DEATH IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE CYPHER STENTS AND THIS PATIENT'S DEATH. HOWEVER, IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT KNOWN. REVIEW OF THE INFORMATION AVAILABLE SUGGESTS THAT THERE ARE PATIENT FACTORS (ADVANCED AGE AND CRITICAL MEDICAL HISTORY) THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S DEATH. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
IT WAS REPORTED THAT R1 ERROR (ROTATION VELOCITY ERROR) APPEARED ON PUMP AFTER A FEW SECONDS OF DELIVERING FLUID. THE ERROR R1 WAS DETECTED WHEN THE NURSES TRIED TO START THE PUMP. LATER, THE EP LAB PERSONNEL ALSO TRIED TO STRENGTHEN THE SCREWS, CHANGED THE TUBING SET, BUT THE ERROR DID NOT DISAPPEAR. THE PATIENT WAS IN FULL ANAESTHESIA. THERE WAS NO DIRECT HARM TO THE PATIENT BECAUSE OF THIS ERROR,AS ABLATION WAS DISABLED, BUT THE PROCEDURE COULD NOT BE PROCEEDED AND WAS RESCHEDULED TO A LATER DATE.
THE REPORT IS FROM THE (B)(4) STUDY. THE TARGET LESIONS WERE THE PROXIMAL TO MID LAD AND THE DISTAL RCA. THE MID LAD WAS 2.75MM IN DIAMETER AND 30MM IN LENGTH. THE LESION WAS DE NOVO AND A TYPE B2 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 70%. THE LESION WAS PRE-DILATED WITH A 3 X 20MM BALLOON AT 14ATM. A CYPHER RX 2.75 X 33MM STENT WAS DEPLOYED AT 18ATM. THE PROXIMAL LAD WAS 2.75MM IN DIAMETER AND 15MM IN LENGTH. THE LESION WAS DE NOVO AND A TYPE B2 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 95%. A CYPHER RX 2.75 X 13MM STENT WAS DEPLOYED AT 22ATM. THE DISTAL RCA WAS 4MM IN DIAMETER AND 20MM IN LENGTH. THE LESION WAS DE NOVO AND A B1 CLASSIFICATION. PRE-PROCEDURE STENOSIS WAS 90%. THE LESION WAS PRE-DILATED WITH A 3 X 20MM BALLOON AT 14ATM. A CYPHER RX 3 X 23MM STENT WAS DEPLOYED AT 20ATM. THE LESION WAS POST-DILATED WITH A 4 X 20MM BALLOON AT 16ATM. THE PATIENT WAS DISCHARGED 3 DAYS POST PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 11/23/2010: THE MID LAD WAS ANATOMICALLY COMPLEX (>= 30MM IN LENGTH). THE PATIENT DIED OF AN UNKNOWN CAUSE ON (B)(6) 2010.
ADDITIONAL INFORMATION RECEIVED (B)(6) 2011: THE ADJUDICATION COMMITTEE DETERMINED THE ELEVATED ENZYMES ON (B)(6) 2009 TO BE AN MI.
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) | 15018698 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Death | ASPIRIN AND CLOPIDOGREL |