CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00257
- Event Type
- Injury
- Date Received
- July 28, 2010
- Date of Event
- June 23, 2010
- Report Date
- July 1, 2010
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
DURING A REPEAT INTERVENTION APPROXIMATELY FOUR YEAR AND THREE MONTHS LATER, THE PHYSICIAN NOTICED DURING THE DIAGNOSTIC PORTION OF THE CASE THAT THE LAD, WHICH HAD PREVIOUSLY BEEN STENTED WITH THREE CYPHER STENTS BACK IN 2006, HAD EXPERIENCED QUITE A BIT OF NEGATIVE REMODELING. HE PERFORMED IVUS OF THE LAD AND DISCOVERED THAT ABOUT 1/3 OF THE STENTED AREA WAS OPPOSED, AND THE REST WAS NOT (SOME PARTS OF THE STENT WERE LITERALLY JUST FLOATING IN THE VESSEL). THE PROXIMAL PART WAS WORSE. HE DILATED THE MALOPPOSED AREA WITH NC QUANTUM APEX BALLOONS UP TO ABOUT A 4.0 DIAMETER. THE LAD LOOKED FINE AND THE STENTS WERE OPPOSED AT THE END OF THE CASE (CONFIRMED BY IVUS AGAIN AT THE END). THEY WILL HAVE TO WORRY ABOUT A LITTLE BIT OF RESTENOSIS DOWN THE ROAD, BUT OTHER THAN THAT THE PATIENT WOULD BE FINE. THEY WERE LUCKY BECAUSE THIS PATIENT HAD LITERALLY JUST STOPPED TAKING HIS PLAVIX PRIOR TO THIS REPEAT INTERVENTION. THE PRODUCT REMAINS IMPLANTED AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF THREE PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2010-00257, 3003742446-2010-00258 AND 3003742446-2010-00259.
A PATIENT EXPERIENCED LATE STENT MALPOSITION SECONDARY TO ANEURYSM APPROXIMATELY FOUR YEARS POST IMPLANTATION OF THREE CYPHER STENTS. THE PATIENT HAD MULTI-VESSEL DISEASE AND UNDERWENT INTERVENTION TO THE LEFT ANTERIOR DESCENDING AND LEFT CIRCUMFLEX DURING THE INDEX PROCEDURE. THE PROXIMAL LAD HAD 80% STENOSIS AND THE DISTAL LAD HAD 60-70% STENOSIS. THREE CYPHER STENTS WERE IMPLANTED IN THE LAD VIA DIRECT STENTING: A 3.00 X 13 MM CYPHER TO THE DISTAL LAD DEPLOYED AT 16 ATM, A 3.50 X 23 MM CYPHER TO THE PROXIMAL LAD DEPLOYED AT 18 ATM, AND A 3.50 X 33 MM CYPHER DEPLOYED AT 16 ATM CONNECTING BOTH STENTS. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. POST-DILATION OF THE PROXIMAL LAD STENT WAS CONDUCTED WITH A 4.0X9 BOSTON NC BALLOON AT 12 ATM TWICE AND THE DISTAL LAD STENT WAS POST-DILATED WITH A 3.5X15MM BOSTON NC BALLOON AT 20 ATM TWICE. IVUS CONFIRMED GOOD WALL APPOSITION. DURING THIS PROCEDURE, A LESION IN THE CIRCUMFLEX ARTERY WAS ALSO TREATED. THE RESIDUAL DIAMETER STENOSIS MEASURED LESS THAN 5%. MEDICATIONS PRESCRIBED AT DISCHARGE INCLUDED ASPIRIN AND PLAVIX. FOUR YEARS POST INDEX PROCEDURE, THE PATIENT HAD A RE-PCI. THE INDICATION FOR THE PROCEDURE WAS UNKNOWN. CORONARY ANGIOGRAPHY REVEALED "THE CYPHER STENTS HAD EXPERIENCED QUITE A BIT OF NEGATIVE REMODELING" IVUS OF THE LAD WAS CONDUCTED AND DISCOVERED THAT "ABOUT 1/3 OF THE STENTED AREA WAS APPOSED, AND THE REST WAS NOT (SOME PARTS OF THE STENT WERE LITERALLY JUST FLOATING IN THE VESSEL)." THE PHYSICIAN POST-DILATED THE MALAPPOSED AREA WITH NC QUANTUM APEX BALLOONS UP TO ABOUT A 4.0 MM DIAMETER. IVUS REVEALED APPROPRIATE STENT APPOSITION AT THAT TIME. REVIEW OF THE PROCEDURAL FILMS BY AN INDEPENDENT CARDIOLOGIST INDICATES THAT THERE WAS POOR APPOSITION OF THE STENTS TO THE LAD AND DIFFUSES ANEURISMAL CHANGES OF THE LEFT ANTERIOR DESCENDING ALL ALONG THE CYPHER STENT LOCATIONS. THE CASE DEMONSTRATES LATE STENT APPOSITION PROBLEMS SECONDARY TO ANEURYSM FORMATION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE TREATMENT CARRIED OUT WITH POST-DILATATION LEAD TO RESOLUTION AND THERE WERE NO APPARENT ADVERSE OUTCOMES. THE FILM REVIEW ALSO INDICATES THAT THERE DON'T SEEM TO BE ANY TECHNICAL FACTORS DURING THE PROCEDURE THAT MAY HAVE LEAD TO THESE FINDING, BUT IT IS NOTED THAT RELATIVELY HIGH PRESSURE INFLATIONS WITH 16 ATMOSPHERE INFLATIONS WERE UTILIZED IN THE INDEX PROCEDURE. THE STENTS WERE APPROPRIATELY SIZED AND THERE WERE NO VESSEL CHARACTERISTICS WHICH COULD HAVE LEAD TO THE END RESULT. 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 THE LOT NUMBERS. LATE STENT MALAPPOSITION, A SEPARATION OF THE STENT STRUTS FROM THE INTIMAL SURFACE OF THE ARTERIAL WALL THAT IS NOT PRESENT IMMEDIATELY AFTER IMPLANTATION, HAS BEEN PREVIOUSLY DOCUMENTED AFTER BRACHYTHERAPY AND BARE-METAL STENT IMPLANTATION. A SUBGROUP ANALYSIS OF THE RAVEL TRIAL REVEALS A LATE STENT MALAPPOSITION AFTER SES IMPLANTATION WITH A SIGNIFICANTLY HIGHER INCIDENCE THAN BARE-METAL STENT. BUT THE MECHANISTIC INTERPRETATION OF THESE DATA ARE HAMPERED BY THE FACT THAT NO IVUS ANALYSIS HAD BEEN PERFORMED DURING THE BASELINE PROCEDURE. THUS, IT IS UNCLEAR WHETHER THE STENTS ARE ALREADY INCOMPLETELY APPOSED AGAINST THE VESSEL WALL DURING THE INDEX PROCEDURE OR THIS IS A LATE ACQUIRED EFFECT. IN THE PRESENT CASE REPORT, SERIAL IVUS WAS PERFORMED AND REVEALED COMPLETE APPOSITION OF THE STENT STRUTS AGAINST THE VESSEL WALL OVER THE ENTIRE LENGTH OF THE STENTED AREA AT BASELINE AND LATE STENT MALAPPOSITION FOUR YEARS LATER SECONDARY TO ANEURYSM FORMATION. THE MECHANISM OF LATE-ACQUIRED INCOMPLETE STENT MALAPPOSITION DUE TO POSITIVE REMODELING IS THOUGHT TO BE RELATED TO CYTOSTATIC EFFECTS OF SIROLIMUS ON NEOINTIMAL FORMATION AND LOCALIZED HYPERSENSITIVITY TO THE POLYMER COATING. SIROLIMUS HAS POTENT ANTI-INFLAMMATORY, IMMUNOSUPPRESSIVE, AND ANTIPROLIFERATIVE EFFECTS. THESE POTENT BIOLOGIC EFFECTS RAISE THEORETIC CONCERNS ABOUT POTENTIAL SIDE EFFECTS, SUCH AS INCOMPLETE HEALING, INCREASED THROMBOGENICITY, NECROSIS, APOPTOSIS, AND POSITIVE REMODELING. CONTINUED SURVEILLANCE AFTER DES IMPLANTATION IS REQUIRED TO DETERMINE THE LONG-TERM SAFETY. WITHOUT THE PRODUCTS FOR EVALUATION, NO DETERMINATION REGARDING POTENTIAL CONTRIBUTING FACTORS COULD BE MADE. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT DIRECT STENTING AND DEPLOYMENT AT 18 ATM AND MULTIPLE POST-DILATIONS CONDUCTED THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. THIS IS ONE OF THREE PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2010-00257, 3003742446-2010-00258 AND 3003742446-2010-00259.
THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH A 60-70% STENOSIS IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) AND 80% STENOSIS IN THE PROXIMAL LAD. IVUS WAS PERFORMED BEFORE STENTING TO CONFIRM SEVERITY AND LENGTH OF STENOSIS. IVUS PERFORMED MORE DISTALLY AND SHOWED DISTAL STENOSIS WAS SIGNIFICANT AND THE DISEASE EXTENDED FROM PROXIMAL TO THE DISTAL VESSEL. IT WAS NOT DOCUMENTED THAT THE LESIONS WERE PRE-DILATED. A 3.0 X 13MM CYPHER IMPLANTED IN THE DISTAL LAD AT 16 ATM, WHICH WAS POST DILATED WITH A 3.5 X 15 MM BOSTON NC BALLOON AT 12 ATMS TWO TIMES. A 3.5 X 23MM CYPHER IMPLANTED IN THE PROXIMAL LAD AT 18 ATM AND POST-DILATED WITH A 4.0 X 9MM BOSTON NC BALLOON AT 12 ATM TWO TIMES. THE TWO STENTS WERE CONNECTED WITH A 3.50 X 33 CYPHER DEPLOYED AT 16 ATM. THE RESIDUAL STENOSIS WAS NONE TO VERY LITTLE (LESS THAN 5%). IVUS WAS PERFORMED AFTER THE STENTS WERE IMPLANTED AND THE CONNECTING STENT WAS AN AREA OF CONCERN. THE STENTED AREA WAS POST-DILATED A COUPLE OF TIMES TO CONFIRM APPOSITION, WHICH WAS AGAIN CONFIRMED WITH IVUS. THE IVUS AFTER STENTING CONFIRMED EXCELLENT SIZING AND MLA (MAXIMUM LUMEN AREA).
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |