CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 9616099-2010-00742
- Event Type
- Injury
- Date Received
- October 4, 2010
- Date of Event
- March 1, 2008
- Report Date
- September 10, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
APPROXIMATELY EIGHT MONTHS AFTER THE STENTS WERE PLACED IN THE RAMUS, THE PATIENT DEVELOPED AN STEMI. ANGIOGRAPHY REVEALED THROMBUS INSIDE THE RAMUS STENTS AND MULTIPLE STENT FRACTURES OF THE STENTS THAT WERE IMPLANTED IN THE RAMUS AND THE LAD. THERE WAS NO THROMBUS IN THE LAD STENTS. THE THROMBUS WAS TREATED WITH BALLOON ANGIOPLASTY, BUT IT WAS UNKNOWN HOW THE FRACTURES WERE TREATED. THE PHYSICIAN FELT THE FRACTURES WERE DUE TO THE LONG STENTING.ASPIRIN 100MG/DAY: 2006-(B)(6) ~ CONTINUING.TICLOPIDINE HYDROCHLORIDE 200MG/DAY: 2006-(B)(6) ~ CONTINUING.HEPARIN DOSE UNKNOWN: DURING PCI.(B)(4) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED (B)(4).ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.THIS IS ONE OF SEVEN PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00738, 9616099-2010-00739, 9616099-2010-00740, 9616099-2010-00741, 9616099-2010-00742, 9616099-2010-00743 AND 9616099-2010-00744.
A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED A MYOCARDIAL INFARCTION DUE A THROMBOTIC EVENT POST IMPLANTATION OF SEVERAL CYPHER STENTS. ADDITIONALLY, SOME OF THE STENTS WERE NOTED TO BE FRACTURED. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED HIS RISK FOR MACE INCLUDES SMOKING. PCI WAS CONDUCTED TO TREAT A LESION IN THE RAMUS INTERMEDIUS DURING THE INDEX PROCEDURE AND A LESION IN THE PROXIMAL LAD DURING A PLANNED STAGED PROCEDURE. THE RAMUS WAS DESCRIBED AS DE NOVO. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE C. THE LESION LENGTH WAS APPROXIMATELY 80 MM AND VESSEL DIAMETER WAS APPROXIMATELY 2.5 MM. THE PROXIMAL LAD LESION WAS A DE NOVO AND THE VESSEL WAS BIFURCATED. AHA/ACC CLASSIFICATION OF THE VESSEL WAS TYPE C. THE LESION LENGTH WAS APPROXIMATELY 60 MM AND VESSEL DIAMETER WAS APPROXIMATELY 2.5 - 3.5 MM. THE (B)(4) IFU CONTRAINDICATES THE USE OF THIS PRODUCT ON THE FOLLOWING LESIONS: THE LEFT MAIN TRUNK, OR OSTIUM OR LESIONS IN THE BIFURCATION AREA. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. IT WAS UNKNOWN IF PRE-DILATION WAS CONDUCTED BEFORE A TOTAL OF FOUR CYPHER STENTS WERE IMPLANTED: TWO 2.5X28 MM AND TWO 2.5X18 MM CYPHER STENTS WERE IMPLANTED AT 18 ATM WITH OVERLAP. INFLATION TIME WAS UNKNOWN. UNKNOWN IF POST-DILATION WAS CONDUCTED FOR ALL 4 STENTS. IVUS WAS CONDUCTED. TIMI FLOW BEFORE AND AFTER THE PROCEDURE WAS UNKNOWN. THE RESIDUAL PERCENT OF STENOSIS WAS UNKNOWN. SEVEN DAYS LATER, A PLANNED STAGED PROCEDURE WAS CONDUCTED TO TREAT THE LESION IN THE PROXIMAL LAD. IT WAS UNKNOWN IF PRE-DILATION WAS CONDUCTED. A 5TH CYPHER (2.5/28 MM) WAS IMPLANTED AT 18 ATM FROM THE DISTAL END OF THE PROXIMAL LAD. A 6TH CYPHER (3.0/18 MM) WAS IMPLANTED AT 16 ATM PROXIMAL TO THE 5TH CYPHER OVERLAPPING IT. THEN, A 7TH CYPHER (3.5/23 MM) WAS IMPLANTED AT 18 ATM PROXIMAL TO THE 6TH CYPHER OVERLAPPING IT. INFLATION TIME WAS UNKNOWN. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. IT WAS UNKNOWN IF POST-DILATION WAS CONDUCTED FOR ALL 3 STENTS. IVUS WAS NOT CONDUCTED. TIMI FLOW BEFORE AND AFTER THE PROCEDURE WAS UNKNOWN. THE RESIDUAL % OF STENOSIS WAS UNKNOWN. UNKNOWN IF ACT WAS MEASURED. MEDICATIONS PRESCRIBED AT DISCHARGE INCLUDED ASPIRIN AND TICLOPIDINE. APPROXIMATELY ONE YEAR AND EIGHT MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED A STEMI AND CORONARY ANGIOGRAPHY REVEALED THROMBUS INSIDE ALL FOUR CYPHER STENTS IMPLANTED IN THE RAMUS. TO TREAT THE THROMBUS, POBA WAS CONDUCTED. IN ADDITION, MULTIPLE STENT FRACTURES WERE OBSERVED IN THE 1ST - 4TH CYPHERS IMPLANTED IN THE RAMUS AND 5TH - 7TH CYPHERS IMPLANTED IN THE PROXIMAL LAD. IT WAS UNKNOWN HOW THE STENT FRACTURES WERE TREATED. THE DEVICE WAS IMPLANTED AND, THEREFORE, NOT AVAILABLE FOR EXTENSIVE 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. WHILE NOT OBSERVED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS, BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. AN INVESTIGATION WAS CONDUCTED SURROUNDING THE INCREASE IN CYPHER STENT FRACTURE COMPLAINTS. AS A RESULT OF THAT INVESTIGATION LABELING CHANGES RELATED TO STENT FRACTURES WERE MADE. ADDITIONAL INVESTIGATION IS ONGOING. THE PHYSICIAN COMMENTED THAT THE PROBABLE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE "THE CYPHER STENTS WERE FRACTURED DUE TO THE LONG STENTING". BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENTS. HOWEVER THERE ARE POSSIBLE PATIENT, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS IS ONE OF SEVEN PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00738, 9616099-2010-00739, 9616099-2010-00740, 9616099-2010-00741, 9616099-2010-00742, 9616099-2010-00743 AND 9616099-2010-00744.
AS REPORTED VIA THE (B)(6) STUDY, A PATIENT EXPERIENCED ST-ELEVATION MYOCARDIAL INFARCTION (STEMI), IN-STENT THROMBOSIS, AND MULTIPLE STENT FRACTURES APPROXIMATELY EIGHT MONTHS AFTER THE INDEX PROCEDURE. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA. THE TARGET LESIONS WERE IN THE RAMUS INTERMEDIUS AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERIES. THE RAMUS LESION WAS DE NOVO, AHA/ACC CLASSIFICATION TYPE C, 80MM IN LENGTH. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. THE LAD LESION WAS DESCRIBED AS DE NOVO, BIFURCATED, AHA/ACC CLASSIFICATION TYPE C AND 60MM IN LENGTH. THE VESSEL DIAMETER WAS 2.5 TO 3.5MM. THE RAMUS LESION WAS TREATED FIRST. IT WAS UNKNOWN IF THE LESION WAS PRE-DILATED. TWO 2.5 X 28MM CYPHERS AND TWO 2.5 X 18MM CYPHERS WERE IMPLANTED WITH OVERLAP. IT WAS UNKNOWN IF THE STENTS WERE POST-DILATED. APPROXIMATELY ONE WEEK LATER, THE PROXIMAL LAD LESION WAS TREATED. IT WAS UNKNOWN IF THE LESION WAS PRE-DILATED. A 2.5 X 28MM CYPHER WAS IMPLANTED AT 18ATM, A 3.0 X 18MM CYPHER WAS IMPLANTED AT 16ATM, AND A 3.5 X 23MM CYPHER WAS IMPLANTED AT 18ATM IN OVERLAPPING FASHION DISTAL TO PROXIMAL. IT WAS UNKNOWN IF THE STENTS WERE POST-DILATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS DE MEXICO | I0506066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| L| R |