CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00289
- Event Type
- Injury
- Date Received
- August 16, 2010
- Date of Event
- May 10, 2010
- Report Date
- July 28, 2010
- 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
POST-PROCEDURE, THE PATIENT HAD A SERIES OF ADVERSE EVENTS: CRITICAL AORTIC STENOSIS THAT WAS TREATED BY VALVULOPLASTY, CONTRAST INDUCED EXACERBATION OF CHRONIC RENAL INSUFFICIENCY, ANEMIA/LOW HEMOGLOBIN THAT WAS TREATED BY TRANSFUSION OF TWO UNITS OF PACKED RED BLOOD CELLS, CONGESTIVE HEART FAILURE (CHF/ACUTE PULMONARY EDEMA), AND ABRUPT RESPIRATORY DISTRESS. THE EVENTS WERE REPORTED TO BE UNRELATED TO THE STUDY DEVICES/PROCEDURE/DRUG AND WERE CAPTURED AS NON-COMPLAINTS. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. THE REPORT RECEIVED FROM (B)(4) STUDY INDICATED THAT A CORONARY ARTERY DISSECTION OCCURRED POST IMPLANTATION OF A CYPHER STENT. THE PATIENT WAS FOUND TO HAVE THREE-VESSEL DISEASE AND HAD TWO LESIONS TREATED DURING THE INDEX PROCEDURE IN THE PROXIMAL CIRCUMFLEX AND THE PROXIMAL LAD. A CYPHER 3.5 X 18 MM STENT (STENT #1) WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL CIRCUMFLEX LESION. THE PROXIMAL LAD TARGET LESION WAS REPORTED TO BE: DE NOVO, 2.5 MM VESSEL DIAMETER, 50 MM LENGTH, A 90% STENOSIS, AND TYPE C. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. THE ACC DEFINES A TYPE C LESION AS A HIGH-RISK LESION WITH LESS THAN 60% SUCCESS RATE OF TREATMENT. PRE-DILATION WAS CONDUCTED BEFORE A CYPHER 2.5 X 13 MM STENT (STENT #2) WAS IMPLANTED AT 12 ATM. AN EDGE DISSECTION WAS NOTED AND WAS TREATED BY IMPLANTATION OF A CYPHER 2.75 X 23 MM (STENT #3) PROXIMAL TO THE FIRST STENT AND OVERLAPPING IT. FINALLY, A CYPHER 2.75 X 33MM STENT (STENT #4) WAS IMPLANTED ALSO IN THE PROXIMAL LAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DISCHARGED TEN DAYS AFTER THE INDEX PROCEDURE. THE RESIDUAL STENOSIS WAS 0%. TIMI III FLOW WAS MAINTAINED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. 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 15120390 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. 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. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND INHERENT PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.
POST ADJUDICATION (B)(4) 2011; CLINICAL IMPRESSION: THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A CORONARY ARTERY DISSECTION OCCURRED POST IMPLANTATION OF A CYPHER STENT, THE PATIENT SUFFERED A NON-Q WAVE MI AND SUBSEQUENTLY EXPIRED FROM CARDIAC RELATED ISSUES. THE PATIENT IS A (B)(6) FEMALE. THE PATIENT'S MEDICAL HISTORY INCLUDES: STABLE ANGINA PECTORIS, FAMILY HISTORY OF CORONARY ARTERY DISEASE (CAD), HYPERTENSION, RENAL INSUFFICIENCY, AND CONGESTIVE HEART FAILURE (CHF). THE PATIENT WAS FOUND TO HAVE THREE-VESSEL DISEASE AND HAD TWO LESIONS TREATED DURING THE INDEX PROCEDURE IN THE PROXIMAL CIRCUMFLEX AND THE PROXIMAL LAD. A CYPHER 3.5 X 18 MM STENT (STENT #1) WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL CIRCUMFLEX LESION. THE PROXIMAL LAD TARGET LESION WAS REPORTED TO BE: DE NOVO, 2.5 MM VESSEL DIAMETER, 50 MM LENGTH, A 90% STENOSIS, AND TYPE C. PRE-DILATION WAS CONDUCTED BEFORE A CYPHER 2.5 X 13 MM STENT (STENT #2) WAS IMPLANTED AT 12 ATM. AN EDGE DISSECTION WAS NOTED AND WAS TREATED BY IMPLANTATION OF A CYPHER 2.75 X 23 MM (STENT #3) PROXIMAL TO THE FIRST STENT AND OVERLAPPING IT. FINALLY, A CYPHER 2.75 X 33MM STENT (STENT #4) WAS IMPLANTED ALSO IN THE PROXIMAL LAD AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE RESIDUAL STENOSIS WAS 0%. TIMI III FLOW WAS MAINTAINED. POST PROCEDURE, AN ELEVATION IN CARDIAC ENZYMES WAS REPORTED AND ADJUDICATED TO HAVE BEEN A NON-Q WAVE MI. POST-PROCEDURE, THE PATIENT HAD A SERIES OF ADVERSE EVENTS: CRITICAL AORTIC STENOSIS THAT WAS TREATED BY VALVULOPLASTY, CONTRAST INDUCED EXACERBATION OF CHRONIC RENAL INSUFFICIENCY, ANEMIA/LOW HEMOGLOBIN THAT WAS TREATED BY TRANSFUSION OF TWO UNITS OF PACKED RED BLOOD CELLS, CONGESTIVE HEART FAILURE (CHF/ACUTE PULMONARY EDEMA, AND ABRUPT RESPIRATORY DISTRESS. THE EVENTS WERE REPORTED TO BE UNRELATED TO THE STUDY DEVICES/PROCEDURE/DRUG AND CAPTURED AS NON-COMPLAINTS. THE PATIENT WAS DISCHARGED TEN DAYS AFTER THE INDEX PROCEDURE. AT AN UNSPECIFIED DATE POST INDEX PROCEDURE, THE PATIENT'S DAUGHTER REPORTED THAT THE PATIENT HAD EXPIRED. THIS EVENT WAS ADJUDICATED AS DEATH SECONDARY TO CARDIAC CAUSES. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. 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. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND INHERENT PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT WAS OF ADVANCED AGE AND HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FOUR PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT # 3003742446-2010-00289, 3003742446-2011-00190, 3003742446-2011-00191, AND 3003742446-2011-00192.
AN ADJUDICATION REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A CORONARY ARTERY DISSECTION OCCURRED POST IMPLANTATION OF A CYPHER STENT, THE PATIENT ALSO SUFFERED A NON-Q WAVE MI AND SUBSEQUENTLY EXPIRED FROM CARDIAC RELATED ISSUES. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF FOUR PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG REPORT # 3003742446-2010-00289, 3003742446-2011-00190, 3003742446-2011-00191, AND 3003742446-2011-00192.
THE REPORT RECEIVED FROM (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAS A TOTAL OF FOUR CYPHER STENTS IMPLANTED DURING THE STUDY INDEX PROCEDURE: A 3.5 X 18 MM IN THE PROXIMAL CIRCUMFLEX; AND THREE IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD)-A 2.5 X 15 MM, 2.75 X 33 MM, AND A 2.75 X 23 MM. THE PATIENT WAS FOUND TO HAVE THREE-VESSEL DISEASE AND HAD TWO LESIONS TREATED DURING THE INDEX PROCEDURE. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS NORMAL (LVEF>50%). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED THE CYPHER 2.5 X 13 MM STENT (STENT #2) IN THE PROXIMAL LAD AT 12 ATM. AN EDGE DISSECTION WAS NOTED AND WAS TREATED BY IMPLANTATION OF A CYPHER 2.75 X 23 MM (STENT #3) PROXIMAL TO THE FIRST STENT AT 12 ATM. A CYPHER 2.75 X 33MM STENT (STENT #4) WAS IMPLANTED IN A SEPARATE LESION IN THE PROXIMAL LAD AT 12 ATM. A CYPHER 3.5 X 18 MM STENT (STENT #1) WAS IMPLANTED IN THE PROXIMAL CIRCUMFLEX AT 8 ATM.
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 | 15120390 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization| L| R | 2.5 X 15 MM BALLOON CATHETER |