CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2013-00059
- Event Type
- Death
- Date Received
- April 8, 2013
- Date of Event
- November 16, 2012
- Report Date
- May 7, 2013
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
ADDENDUM: ADDITIONAL INFORMATION RECEIVED THROUGH ADJUDICATION MINUTES INDICATED THAT THE COMMITTEE AGREED WITH THE EVENT OF CORONARY STENT THROMBOSIS AS A CAUSE OF PREVIOUSLY REPORTED DEATH. PLEASE FIND UPDATED SECTIONS WITH THE NEW EVENT OF THROMBOSIS WITH PREVIOUSLY REPORTED EVENT OF DEATH. UPDATED COMPLAINT CONCLUSION: THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT DIED DUE TO UNKNOWN REASONS APPROXIMATELY TWO YEARS POST INDEX PROCEDURE. THE PATIENT¿S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, MOST RECENT MI (B)(6) 2009, CONGESTIVE HEART FAILURE, RENAL INSUFFICIENCY, SMOKING - GREATER THAN 30 DAYS, (B)(6), SMALL CELL LYMPHOMA, PULMONARY EDEMA, CHRONIC KIDNEY DISEASE, ANEMIA, LEUKOPENIA, UPPER GASTROINTESTINAL BLEED, PEPTIC ULCER DISEASE, ALLERGIC RHINITIS, AND HISTORY OF CANCER. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED A LESION IN THE PROXIMAL CX THAT WAS DESCRIBED AS 20 MM IN LENGTH, CLASS B1, AND DE NOVO. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA AND +VE FUNCTIONAL TEST FOR ISCHEMIA. THE REFERENCE VESSEL WAS 2.75 MM IN DIAMETER. AS PLANNED, THE LESION WAS PREDILATED WITH A 3.5X20 MM BALLOON. THEN A 3.5X13 MM CYPHER OTW WAS IMPLANTED. THEREAFTER A SECOND 3X23 MM CYPHER OTW WAS IMPLANTED IN ORDER TO FULLY COVER THE LESION. AS A STANDARD PROCEDURE, THE SEGMENT WAS POST DILATED WITH A 3.5X20 MM BALLOON. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED A DAY LATER. 2 YEARS LATER, THE PATIENT DIED DUE TO UNKNOWN CAUSE. ADDITIONAL INFORMATION RECEIVED THROUGH ADJUDICATION MINUTES INDICATED THAT THE COMMITTEE AGREED WITH THE EVENT OF CORONARY STENT THROMBOSIS AS A CAUSE OF PREVIOUSLY REPORTED DEATH. THE STUDY STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE IS NO LOT NUMBER INFORMATION AVAILABLE AND THUS NO DHR COULD BE PERFORMED. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH DRUG ELUTING STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. ELUTED DRUGS INHIBIT EPITHELIALIZATION IN AN EFFORT TO PREVENT RESTENOSIS. DUAL ANTI-PLATELET THERAPY IS USED TO ASSIST IN THE PREVENTION OF THROMBUS ON THE INSIDE OF THE STENT, SECONDARY TO PLATELETS ATTACHING TO THE DISTURBED INTIMAL LAYERS AND METAL STENT STRUTS POST STENT IMPLANTATION. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00059 AND 3003742446-2013-00060.
CONCOMITANT MEDICATIONS INCLUDED AMLODIPINE BESYLATE, ASPIRIN, BETA BLOCKING AGENTS, BIVALIRUDIN, BUMETANIDE, CALCIUM CHANNEL BLOCKERS, PLAVIX, HMG COA REDUCTASE INHIBITORS, ISOSORBIDE MONONITRATE, LORAZEPAM, METOLAZONE, METOPROLOL, NITROGLYCERIN, AND SIMVASTATIN. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT DIED DUE TO UNKNOWN REASONS APPROXIMATELY TWO YEARS POST INDEX PROCEDURE. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, MOST RECENT MI (B)(6) 2009, CONGESTIVE HEART FAILURE, RENAL INSUFFICIENCY, SMOKING- GREATER THAN 30 DAYS, (B)(6), SMALL CELL LYMPHOMA, PULMONARY EDEMA, CHRONIC KIDNEY DISEASE, ANEMIA, LEUKOPENIA, UPPER GASTROINTESTINAL BLEED, PEPTIC ULCER DISEASE, ALLERGIC RHINITIS, AND HISTORY OF CANCER. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED A LESION IN THE PROXIMAL CX THAT WAS DESCRIBED AS 20MM IN LENGTH, CLASS B1, AND DE NOVO. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA AND +VE FUNCTIONAL TEST FOR ISCHEMIA. THE REFERENCE VESSEL WAS 2.75MM IN DIAMETER. AS PLANNED, THE LESION WAS PREDILATED WITH A 3.5X20MM BALLOON. THEN A 3.5X13MM CYPHER OTW WAS IMPLANTED. THEREAFTER A SECOND 3X23MM CYPHER OTW WAS IMPLANTED IN ORDER TO FULLY COVER THE LESION. AS A STANDARD PROCEDURE, THE SEGMENT WAS POST DILATED WITH A 3.5X20MM BALLOON. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED A DAY LATER. 2 YEARS LATER, THE PATIENT DIED DUE TO UNKNOWN CAUSE. THE STUDY STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE IS NO LOT NUMBER INFORMATION AVAILABLE AND THUS NO DHR COULD BE PERFORMED. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. REVIEW OF THE AVAILABLE INFORMATION DOES NOT ALLOW FOR AN EXACT DETERMINATION OF CAUSAL FACTORS; HOWEVER, THE PATIENT HAD MULTIPLE MEDICAL CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED DEATH. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00059 AND 3003742446-2013-00060.
THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT DIED DUE TO UNKNOWN REASONS APPROXIMATELY TWO YEARS POST INDEX PROCEDURE. AT THE TIME OF INDEX PROCEDURE, THE ANGIOGRAPHY REVEALED A LESION IN THE PROXIMAL CX THAT WAS DESCRIBED AS 20MM IN LENGTH, CLASS B1, AND DE NOVO. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA AND +VE FUNCTIONAL TEST FOR ISCHEMIA. THE REFERENCE VESSEL WAS 2.75MM IN DIAMETER. AS PLANNED, THE LESION WAS PREDILATED WITH A 3.5X20MM BALLOON. THEN A 3.5X13MM CYPHER OTW WAS IMPLANTED. THEREAFTER, A SECOND 3X23MM CYPHER OTW WAS IMPLANTED IN ORDER TO FULLY COVER THE LESION. AS A STANDARD PROCEDURE, THE SEGMENT WAS POST DILATED WITH A 3.5X20MM BALLOON. THERE WERE NO PROCEDURAL COMPLICATIONS REPORTED AND THE PATIENT WAS DISCHARGED A DAY LATER. 2 YEARS LATER, THE PATIENT DIED DUE TO UNKNOWN CAUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143518 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Death |