CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2011-00212
- Event Type
- Injury
- Date Received
- April 28, 2011
- Date of Event
- March 7, 2011
- Report Date
- April 1, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
INFORMATION RECEIVED FROM THE CYPRESS STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, PREVIOUS CORONARY ARTERY BYPASS GRAFT SURGERY, HYPERLIPIDEMIA, HYPERTENSION, PERIPHERAL VASCULAR DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND SMOKING. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA. THE TARGET LESION WAS THE FIRST DIAGONAL (DX1). THE LESION WAS DESCRIBED AS DE NOVO, 95% STENOSED, 6MM IN LENGTH, AND 2.5MM IN DIAMETER. THE LESION WAS DIRECT STENTED WITH A 2.5MM X 8MM CYPHER STENT AT 18 ATMS. THE STENT WAS SUCCESSFULLY DEPLOYED AND DID NOT REQUIRE POST-DILATION. THE REPORTED RESIDUAL STENOSIS WAS 0%. TEN MONTHS LATER THE PATIENT UNDERWENT REVASCULARIZATION OF THE FIRST DIAGONAL WITH IMPLANTATION OF AN UNKNOWN BARE METAL STENT. THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS POSSIBLY RELATED TO CORDIS PRODUCT. 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. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND IS MOST PREVALENT IN PATIENTS WITH DIABETES, HYPERTENSION, PEOPLE THAT SMOKE, AND SMALL LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PATIENT FACTORS AND/OR LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.
ADDITIONAL INFORMATION WAS RECEIVED AND WAS UPDATED.
ADDITIONAL INFORMATION WAS RECEIVED. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00212, 3003742446-2011-00429, AND 3003742446-2011-00430.
THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00212, 3003742446-2011-00429, AND 3003742446-2011-00430. AS REPORTED BY THE (B)(4) STUDY, THE PATIENT UNDERWENT REVASCULARIZATION OF THE FIRST DIAGONAL APPROXIMATELY TEN MONTHS AFTER THE INDEX PROCEDURE. APPROXIMATELY FOURTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF SAPHENOUS VEIN GRAFT (SVG) TO THE DIAGONAL. PAST MEDICAL HISTORY INCLUDES ANGINA, CORONARY ARTERY BYPASS GRAFT SURGERY, HYPERLIPIDEMIA, HYPERTENSION, PERIPHERAL VASCULAR DISEASE/CLAUDICATION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, SMOKING, PREVIOUS CYPHER STENT IMPLANTATION. DURING THE INDEX PROCEDURE, A LESION LOCATED IN THE FIRST DIAGONAL WAS TREATED. THIS VESSEL HAD TWO PREVIOUSLY IMPLANTED CYPHER STENTS. THE LESION WAS DESCRIBED AS 95% STENOSED, TYPE C, 6MM IN LENGTH, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER AND NON-TORTUOUS. A 2.5X8MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 18ATMS. IT WAS REPORTED BY THE SITE THAT OF THE TWO PREVIOUSLY IMPLANTED CYPHER RX STENTS ONLY ONE OF THESE STENTS WAS IMPLANTED NEAREST THE 2.5X8MM CYPHER RX STENT THAT WAS IMPLANTED DURING THE INDEX PROCEDURE. ADDITIONALLY, THE TARGET LESION TREATED DURING THE INDEX PROCEDURE WAS DISTAL TO THE PREVIOUSLY IMPLANTED CYPHER STENT. NO PRE AND POST-DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED DURING THE PROCEDURE. TEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF THE FIRST DIAGONAL WITH IMPLANTATION OF AN UNKNOWN BARE METAL STENT. APPROXIMATELY FOURTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF SAPHENOUS VEIN GRAFT (SVG) TO THE DIAGONAL WITH IMPLANTATION OF A NON-CORDIS STENT. THE LESION WAS DISTAL TO THE ANASTOMOSIS OF THE SVG. TREATMENT FOR THIS REVASCULARIZATION INCLUDED IMPLANTATION OF A NON-CORDIS STENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE LOT FOR (B)(4) PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TYPE OF TREATMENT OF THE DISEASE PROCESS AND IT IS NOT A PREVENTION OR CURE OF THE PROGRESSION OF ATHEROSCLEROTIC ARTERY DISEASE. THE INFORMATION AVAILABLE SUGGESTS THAT THERE ARE PATIENT, VESSEL ALONG WITH PROGRESSION OF EXISTING CORONARY ARTERY DISEASE THAT MAY HAVE CONTRIBUTED TO THE REPORTED RESTENOSIS EVENTS. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 THAT REPORTED APPROXIMATELY FOURTEEN MONTHS AFTER THE INDEX PROCEDURE THE PATIENT UNDERWENT REVASCULARIZATION WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.
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
ADDITIONAL INFORMATION WAS RECEIVED THAT CONFIRMED THE PATIENT UNDERWENT REVASCULARIZATION OF THE FIRST DIAGONAL ON (B)(6) 2011. TREATMENT INCLUDED IMPLANTATION OF AN UNKNOWN BARE METAL STENT. THE EVENT WAS REPORTED AS POSSIBLY RELATED TO CORDIS PRODUCT. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVED WITHOUT SEQUELAE.
ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT HAD A HISTORY OF IMPLANTATION OF TWO CYPHER RX STENTS ON (B)(6) 2006. IT WAS REPORTED BY THE SITE THAT OF THE TWO CYPHER RX STENTS IMPLANTED ON (B)(6) 2006, ONLY ONE OF THESE STENTS WAS IMPLANTED NEAREST THE 2.5X8MM CYPHER RX STENT (IMPLANTED ON (B)(6) 2010). IT WAS ALSO REPORTED BY THE SITE THAT THE PHYSICIAN NOTED THAT DURING THE INDEX PROCEDURE, THE TARGET LESION (LOCATED IN THE FIRST DIAGONAL) WAS DISTAL TO A PREVIOUS STENT. THE SITE REPORTED THAT THE REVASCULARIZATION PERFORMED ON (B)(6) 2011 WAS OF THE SAPHENOUS VEIN GRAFT (SVG) TO THE DIAGONAL; WHILE THE TARGET LESION WAS DISTAL TO THE ANASTOMOSIS OF THE SVG. TREATMENT FOR THE REVASCULARIZATION ON (B)(6) 2011 INCLUDED IMPLANTATION OF A NON-CORDIS STENT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. THE PATIENT WAS NOT DECEASED ACCORDING TO THE SOCIAL SECURITY DEATH INDEX, BUT THE PATIENT COULD NOT BE REACHED FOR THE 15 MONTH VISIT.
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 | 15116868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |