CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00243
- Event Type
- Injury
- Date Received
- July 19, 2010
- Date of Event
- May 19, 2010
- Report Date
- June 22, 2010
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
ADDITIONAL INFORMATION REPORTED BY THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A MYOCARDIAL INFARCTION DUE TO PLAQUE SHIFT THE FOLLOWING DAY POST IMPLANTATION OF A CYPHER STENT. DURING THE INDEX PROCEDURE, A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS TREATED. THE LESION WAS DESCRIBED AS DE NOVO, 95% STENOSED, 9MM IN LENGTH, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. PRE-DILATION WAS NOT PERFORMED. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. A 3.5X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 14ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. WHEN THE PATIENT WAS DISCHARGED THE FOLLOWING DAY, HE DEVELOPED MORE CHEST PAIN AND WAS SUBSEQUENTLY RE-ADMITTED. THE PATIENT WAS RULED-IN FOR NON Q-WAVE MI. PEAK CK UPON ADMISSION WAS 82. THE PATIENT WAS SENT TO THE CARDIAC CATHETERIZATION LAB AND IT WAS DISCOVERED THAT PLAQUE HAD PROLAPSED AT THE SITE OF THE CYPHER RX STENT. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY. THE CHEST PAIN RESOLVED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. 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. LUMEN ENLARGEMENT DURING CORONARY STENTING RESULTS FROM VESSEL EXPANSION AND AXIAL REDISTRIBUTION OF ATHEROMATOUS PLAQUE ALONG THE STENTED SEGMENT AND PROXIMAL AND DISTAL SEGMENTS, PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. THIS ACTION CAN EXHIBIT ITSELF AS CHEST PAIN, EKG CHANGES AND CARDIAC ENZYMES INCREASE LEADING TO MYOCARDIAL INFARCTION DIAGNOSIS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE LESION CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS.
ADDITIONAL INFORMATION RECEIVED REGARDING THE REVASCULARIZATION EVENT REPORTED THAT OCCURRED IN (B)(6) 2010, PLEASE NOTE THE EVENT START DATE REPORTED WAS (B)(6) 2010. THE EVENT STOPPED DATE WAS (B)(6) 2010.
ADDITIONAL INFORMATION WAS RECEIVED VIA THE CASE REPORT FORM. THE DATE OF THE MYOCARDICAL INFARCTION AND PLAQUE SHIFT WAS (B)(6) 2010 INSTEAD OF (B)(6) 2010 AS PREVIOUSLY REPORTED.
ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
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. LUMEN ENLARGEMENT DURING CORONARY STENTING RESULTS FROM VESSEL EXPANSION AND AXIAL REDISTRIBUTION OF ATHEROMATOUS PLAQUE ALONG THE STENTED SEGMENT AND PROXIMAL AND DISTAL SEGMENTS, PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. THIS ACTION CAN EXHIBIT ITSELF AS CHEST PAIN, EKG CHANGES AND CARDIAC ENZYMES INCREASE. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE LESION CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS.
THE COMPLAINT RECEIVED STATES THAT THE DAY AFTER THE INDEX PROCEDURE, THIS (B)(4) STUDY PATIENT SUFFERED CARDIAC CHEST PAIN, AN MI AND HAD TARGET LESION REVASCULARIZATION SECONDARY TO CORONARY RESTENOSIS. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING ANGINA, HYPERLIPIDEMIA, SMOKING, CORONARY ARTERY DISEASE, AND BENIGN PROSTATIC HYPERTROPHY. DURING THE INDEX PROCEDURE, A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS TREATED. THE INDICATION FOR THE PROCEDURE WAS ACUTE CORONARY SYNDROME. THE LESION WAS DESCRIBED AS DE NOVO, 95% STENOSED, 9MM IN LENGTH, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. PRE-DILATION WAS NOT PERFORMED. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. A 3.5X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 14ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. WHEN THE PATIENT WAS DISCHARGED THE FOLLOWING DAY, HE DEVELOPED MORE CHEST PAIN AND WAS SUBSEQUENTLY RE-ADMITTED. THE PATIENT WAS RULED-IN FOR MI. PEAK CK UPON ADMISSION WAS 82. THE PATIENT WAS SENT TO THE CARDIAC CATHETERIZATION LAB AND IT WAS DISCOVERED THAT PLAQUE HAD PROLAPSED AT THE SITE OF THE CYPHER RX STENT. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY. THE CHEST PAIN RESOLVED AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION. 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 15109103 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. CORONARY RESTENOSIS SECONDARY TO PLAQUE SHIFT MAY OCCUR DURING CORONARY STENTING FROM VESSEL EXPANSION AND AXIAL REDISTRIBUTION OF ATHEROMATOUS PLAQUE ALONG THE STENTED SEGMENT AND PROXIMAL AND DISTAL SEGMENTS, PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. THIS ACTION CAN EXHIBIT ITSELF AS CARDIAC CHEST PAIN, EKG CHANGES AND CARDIAC ENZYMES INCREASE LEADING TO MYOCARDIAL INFARCTION DIAGNOSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE POSSIBLE LESION CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS.
AS REPORTED BY (B)(4) STUDY, FOLLOWING THE INDEX PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN AND UNDERWENT REVASCULARIZATION. THE PATIENT ALSO EXPERIENCED PLAQUE SHIFT AT THE SITE OF THE CYPHER STENT. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS DESCRIBED AS DE NOVO, 95% STENOSED, 9MM IN LENGTH, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. PRE-DILATION WAS NOT PERFORMED. A 3.5X13MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 14ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. AS THE PATIENT LEFT THE SITE, HE DEVELOPED MORE CHEST PAIN AND WAS SUBSEQUENTLY RE-ADMITTED. THE PATIENT WAS SENT TO THE CARDIAC CATHETERIZATION LAB AND IT WAS DISCOVERED THERE WAS PLAQUE SHIFT AT THE SITE OF THE CYPHER RX STENT. THERE WAS ALSO A SLIGHT INCREASE IN THE PATIENT'S TROPONIN LEVEL (CK 56; CK-MB 3.5). THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY. THE CHEST PAIN RESOLVED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE.
ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT HAD A REVASCULARIZATION ON (B)(6) 2010. THE EVENT WAS TREATED WITH PTCA. THE EVENT WAS REPORTED TO BE OF MODERATE SEVERITY AND RESOLVED WITHOUT SEQUELAE.
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 | 15109103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R | PRASUGREL 10MG |