CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 9616099-2014-00147
- Event Type
- Injury
- Date Received
- February 27, 2014
- Date of Event
- January 1, 2014
- Report Date
- February 6, 2014
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
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
CORRECTION: THE CATALOG CODE PREVIOUSLY PROVIDED (CRBXXXXX) AS THE UNKNOWN CYPHER CATALOG CODE WAS PROVIDED INCORRECTLY. THE CATALOG CODE HAS BEEN CORRECTED TO "CYPHER," WHICH IS THE CATALOG CODE FOR AN UNKNOWN CYPHER STENT USED IN THE UNITED STATES. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PATIENT CURRENTLY REMAINS UNKNOWN. THIS IS ONE OF FIVE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00147, 9616099-2014-00148, 9616099-2014-00149, 9616099-2014-00150, AND 9616099-2014-00151. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY ALQARQAZ ET AL MULTIPLE AND RECURRENT CORONARY STENT FRACTURES, THE JOURNAL OF INVASIVE CARDIOLOGY 26 (2014) E7-E12; A (B)(6) FEMALE HAD RECURRENT MULTIPLE LEFT ANTERIOR DESCENDING (LAD) ARTERY CYPHER STENT FRACTURES, MYOCARDIAL INFARCTIONS (MI), STENT RESTENOSIS, AND THROMBOSIS. PAST MEDICAL HISTORY INCLUDED HYPERTENSION, DYSLIPIDEMIA, AND CIGARETTE SMOKING. INITIAL CORONARY ANGIOGRAM (2003),AT (B)(6), DUE TO ANTERIOR ST SEGMENT MI, REVEALED 90% STENOSIS IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH DEPLOYMENT OF TWO OVERLAPPING 2.5 X 28 MM AND 2.5 X 18 MM CYPHER STENTS IN THE 90% STENOSED MID LAD ARTERY WITH GOOD ANGIOGRAPHIC RESULTS. EIGHT MONTHS LATER, THE PATIENT PRESENTED TO ANOTHER HOSPITAL WITH CHEST PAIN; ECG SHOWED ANTERIOR ST-SEGMENT ELEVATION MI. TWO DAYS LATER, SHE UNDERWENT CORONARY ANGIOGRAPHY, WHICH REVEALED A 70% MID-LAD LESION AND A COMPLETE STENT FRACTURE (SF) INVOLVING THE MORE DISTAL LAD STENT. A THIRD CYPHER STENT (2.75 X 8 MM) WAS DEPLOYED ACROSS THE FRACTURED STENT. THE PATIENT DEVELOPED A PROXIMAL LAD CATHETER-INDUCED DISSECTION DURING THE PROCEDURE, WHICH WAS TREATED WITH ANOTHER CYPHER STENT (3 X 13MM) DEPLOYED IN THE PROXIMAL LAD ARTERY, WITH A GOOD ANGIOGRAPHIC RESULT. APPROXIMATELY TWO YEARS LATER, THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY AFTER PRESENTING WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS FOUND TO HAVE TWO COMPLETE SFS, RESULTING IN FOCAL 60% IN-STENT RESTENOSIS (ISR) AT THE CORRESPONDING SF SITE. GIVEN THAT HER SYMPTOMS IMPROVED WITH MEDICAL MANAGEMENT, A DECISION WAS MADE NOT TO PERFORM PCI AT THAT POINT. THREE YEARS LATER SHE PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH AN ANTERIOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. IN THE ED, SHE DEVELOPED VENTRICULAR FIBRILLATION AND RESPONDED QUICKLY TO RESUSCITATION AND ELECTRICAL DEFIBRILLATION. SHE UNDERWENT EMERGENT CORONARY ANGIOGRAPHY, WHICH REVEALED COMPLETE MID-LAD ARTERY OCCLUSION WITH EVIDENCE OF STENT THROMBOSIS. THE TWO PREVIOUSLY KNOWN SFS WERE ALSO IDENTIFIED WITH GREATER DISPLACEMENT WHEN COMPARED TO THE ANGIOGRAPHY PERFORMED THREE YEARS PRIOR. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THE ABSENCE OF STENT STRUTS IN THE TWO SF SITES CORRESPONDING TO THE TWO ANGIOGRAPHICALLY IDENTIFIED SF LOCATIONS. THE MORE DISTAL FRACTURE WAS TREATED WITH DEPLOYMENT OF 2.5 X 8 MM CYPHER STENT, WHILE THE PROXIMAL FRACTURE WAS TREATED BY PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WITH SATISFACTORY RESULTS. THE PATIENT REMAINED STABLE FROM A CARDIAC STANDPOINT APPROXIMATELY THREE YEARS LATER, WHEN SHE EXPERIENCED RECURRENT ANGINA ON EXERTION. STRESS ECHOCARDIOGRAPHY SHOWED ANTERIOR-WALL ISCHEMIA SUGGESTIVE OF LAD ARTERY STENOSIS. CORONARY ANGIOGRAPHY REVEALED TWO SFS WITH COMPLETE SEPARATION OF STENT SEGMENTS AT THE PREVIOUS FRACTURE SITES, RESULTING IN COMPLETE OCCLUSION OF THE MID- LAD ARTERY WITH RIGHT-TO-LEFT COLLATERALS. A 50%-60% STENOSIS OF THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY WAS ALSO NOTED. THE PATIENT WAS REFERRED FOR CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. A FEW DAYS LATER, SHE UNDERWENT CABG SURGERY. HER CABG SURGERY WAS UNEVENTFUL. AT 3- MONTH FOLLOW-UP EXAM, THE PATIENT WAS ASYMPTOMATIC FROM A CARDIAC STANDPOINT, WITH GOOD FUNCTIONAL CAPACITY. OF NOTE, THE PATIENT HAS BEEN ON DUAL-ANTIPLATELET THERAPY WITH ASPIRIN AND CLOPIDOGREL SINCE HER FIRST PCI. THE DEVICES REMAIN IMPLANTED IN THE PATIENT, THEREFORE THEY ARE NOT AVAILABLE FOR ANALYSIS. REVIEW OF LOTS 40204020, 14031853, A0304375 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENTS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE REMAINING PRODUCTS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. RESTENOSIS, MYOCARDIAL INFARCTION AND THROMBOSIS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS, MYOCARDIAL INFARCTION AND THROMBOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. IN THIS CASE, THE INITIAL LESION IN THE MID LAD WAS TREATED WITH 2 OVERLAPPING STENTS MEASURING A TOTAL OF 38MM (2.5X28 AND 2.5X18MM). 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. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION AND IN AREAS OF OVERLAPPING STENTS. LONGER STENTS (OR OVERLAPPING) OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. THE MECHANISM OF RESTENOSIS AFTER STENT FRACTURE MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENTS OF STENT FRACTURE, RESTENOSIS, THROMBOSIS AND MYOCARDIAL INFARCTIONS REPORTED. HOWEVER, PATIENT PRE-DISPOSING FACTORS IN THE MEDICAL HISTORY AND LESION CHARACTERISTICS (38MM LONG AND 2.5MM IN DIAMETER) WITH MULTIPLE STENT PLACEMENT ARE LIKELY CONTRIBUTING FACTORS TO THE EVENTS REPORTED. BASED ON THE DEVICE HISTORY RECORD REVIEWS CONDUCTED FOR THE KNOWN LOTS, THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW ON THE REMAINING DEVICES AND WITHOUT THE PRODUCTS AVAILABLE FOR EVALUATION, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED STENT FRACTURES COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS NOTED IN THE PUBLICATION BY ALQARQAZ ET AL MULTIPLE AND RECURRENT CORONARY STENT FRACTURES, THE JOURNAL OF INVASIVE CARDIOLOGY 26 (2014) E7-E12; A (B)(6) FEMALE HAD RECURRENT MULTIPLE LEFT ANTERIOR DESCENDING (LAD) ARTERY CYPHER STENT FRACTURES, MYOCARDIAL INFARCTIONS (MI), STENT RESTENOSIS, AND THROMBOSIS. AFTER PRESENTING WITH CHEST PAIN, THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH DEPLOYMENT OF TWO OVERLAPPING 2.5 X 28 MM AND 2.5 X 18 MM CYPHER STENTS IN THE 90% STENOSED MID LAD ARTERY WITH GOOD ANGIOGRAPHIC RESULTS. EIGHT MONTHS LATER, THE PATIENT PRESENTED TO ANOTHER HOSPITAL WITH CHEST PAIN; ECG SHOWED ANTERIOR ST-SEGMENT ELEVATION MI. TWO DAYS LATER, SHE UNDERWENT CORONARY ANGIOGRAPHY, WHICH REVEALED A 70% MID-LAD LESION AND A COMPLETE STENT FRACTURE (SF) INVOLVING THE MORE DISTAL LAD STENT. A THIRD CYPHER STENT (2.75 X 8 MM) WAS DEPLOYED ACROSS THE FRACTURED STENT. THE PATIENT DEVELOPED A PROXIMAL LAD CATHETER-INDUCED DISSECTION DURING THE PROCEDURE, WHICH WAS TREATED WITH ANOTHER CYPHER STENT (3 X 13MM) DEPLOYED IN THE PROXIMAL LAD ARTERY, WITH A GOOD ANGIOGRAPHIC RESULT. APPROXIMATELY TWO YEARS LATER, THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY AFTER PRESENTING WITH NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS FOUND TO HAVE TWO COMPLETE SFS, RESULTING IN FOCAL 60% IN-STENT RESTENOSIS (ISR) AT THE CORRESPONDING SF SITE. GIVEN THAT HER SYMPTOMS IMPROVED WITH MEDICAL MANAGEMENT, A DECISION WAS MADE NOT TO PERFORM PCI AT THAT POINT. THREE YEARS LATER, SHE PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH AN ANTERIOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. IN THE ED, SHE DEVELOPED VENTRICULAR FIBRILLATION AND RESPONDED QUICKLY TO RESUSCITATION AND ELECTRICAL DEFIBRILLATION. SHE UNDERWENT EMERGENT CORONARY ANGIOGRAPHY, WHICH REVEALED COMPLETE MID-LAD ARTERY OCCLUSION WITH EVIDENCE OF STENT THROMBOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122465 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| L| R| S |