CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2014-00044
- Event Type
- Injury
- Date Received
- September 24, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 25, 2014
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ON (B)(6) 2008, FOLLOWING THE QUADRUPLE BYPASS, PATIENT WAS IN THE ICU ON A RESPIRATOR AND THE SURGEON WHO PERFORMED THE BYPASS YELLING AT HER FOR LETTING THE PREVIOUS SURGEON IMPLANT SO MANY STENTS, WHICH MADE THE BYPASS ALMOST IMPOSSIBLE. PATIENT ADDITIONALLY REPORTED THAT SHE HAD THOUGHT THAT AFTER THE QUADRUPLE BYPASS ALL OF HER STENTS WOULD HAVE BEEN REMOVED, BUT THEY WERE NOT AND SHE NOW HAS A WIRE IN HER CHEST VISIBLE ON X-RAY THAT PROHIBITS HER FROM GOING THROUGH CERTAIN METAL DETECTORS. BEGINNING ON (B)(6) 2014, PATIENT WAS DIAGNOSED WITH "DOUBLE" PNEUMONIA AND HER "O2 SATS" DROPPED, IT WAS NOT CLARIFIED IF PATIENT WAS HOSPITALIZED. PATIENT WAS PRESCRIBED LEVOFLOXACIN AND DEVELOPED AN UNSPECIFIED ALLERGY. AS TREATMENT FOR THE PNEUMONIA, ON (B)(6) 2014, PATIENT BEGAN USING OXYGEN AT NIGHT AND IN (B)(6) 2014, PATIENT WAS PRESCRIBED THE USE OF AN UNSPECIFIED NEBULIZER. PNEUMONIA RESOLVED WITH SEQUELAE OF CONGESTION ON 2014/U/U AND BEING A SHALLOW BREATHER, PATIENT HAS CONTINUED ON OXYGEN AT NIGHT, AND NEBULIZER TREATMENT WAS DISCONTINUED ON 2014/U/U. BEGINNING ON 2014/U/U, "THE OTHER DAY" PATIENT EXPERIENCED HER BLOOD PRESSURE MEDICATION NOT WORKING DESCRIBED AS A BLOOD PRESSURE OF 200/98, FOR WHICH PHYSICIAN WAS AWARE. NO FURTHER INFORMATION WAS AVAILABLE. PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF 8 CYPHER STENTS WITH UNKNOWN CATALOG AND LOT NUMBERS. THE EVENT DATE CHOSEN WAS FOR PURPOSES OF SUBMITTING THE REPORT SINCE THE EVENT DATES WERE NOT PROVIDED. THIS IS ONE OF TWO REPORTS ASSOCIATED WITH THIS PATIENT THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBER 3003742446-2014-00045.
ADDITIONAL INFORMATION WAS REQUESTED FROM THE PATIENT WHO PROVIDED DETAILS OF THE DEVICES THAT WERE IMPLANTED. THE PATIENT READ OUT THE DETAILS FROM THE IMPLANT CARDS, ¿(B)(4)? 1 CORDIS, IMPLANTED ON (B)(6) 2001, RCA DISTAL, (B)(4). THESE NUMBERS WERE NOT RECOGNIZED BY THE SYSTEM. THEN THERE WERE 2 MORE STENTS, (B)(4) (2), IMPLANTED ON AN UNSPECIFIED DATE PLACED IN THE SVG AND PDA. TWO ADDITIONAL STENTS, (B)(4), WERE PLACED IN THE LAD ON (B)(6) 2003. THERE WERE TWO MORE STENTS, (B)(4), THAT WERE PLACED IN THE PDA ON (B)(6) 2005. THE PATIENT WAS UNABLE TO FOLLOW UP WITH THE PHYSICIAN WHO IMPLANTED THE STENTS AS SHE LIVES IN ANOTHER TOWN. AS THE FIRST DEVICE COULD NOT BE DETERMINED, THE DEVICE IS CONSIDERED AN UNKNOWN CORDIS PRODUCT. NO FURTHER PRODUCT DETAILS ARE AVAILABLE. A (B)(6) FEMALE CYPHER PATIENT CALLED FOR STENT CARD REPLACEMENT AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON U/U/U PATIENT EXPERIENCED AN UNKNOWN BLOCKAGE WHICH RESULTED IN TWO UNSPECIFIED BARE METAL STENTS BEING IMPLANTED IN AN UNKNOWN VESSEL ON 2000/U/U, ABOUT 14-YEARS AGO. DURING A 5-YEAR TIME PERIOD FROM ABOUT 2004-2009 PATIENT EXPERIENCED AN UNKNOWN NUMBER OF BLOCKAGES WHICH RESULTED IN 8 OR 9 CYPHER SIROLIMUS DRUG-ELUTING STENTS BEING IMPLANTED IN UNKNOWN VESSELS, DESCRIBED AS MAYBE THE CORONARY ARTERY BUT PATIENT WAS "NOT REALLY SURE". EACH CYPHER STENT PLACEMENT REQUIRED AN OVERNIGHT STAY UNTIL THE FACILITY BEGAN USING A VASOSEALER WHICH THEN MADE THE PROCEDURES AN OUT-PATIENT PROCEDURE. ON U/U/U, AFTER ONE OF THE CYPHER STENT IMPLANTS, PATIENT'S IMPLANTATION SITE OPENED AND BLED PROFUSELY AND AS TREATMENT THE DOCTOR APPLIED PRESSURE TO THE AREA UNTIL IT STOPPED BLEEDING. THIS WAS REPORTED BY THE PATIENT TO BE PRIOR TO THE USE OF THE "VASOSEALER". ON U/U/U ONE OF THE CYPHER STENT IMPLANTS, WAS "TRICKY" DESCRIBED AS ONE STENT BEING INSERTED THROUGH ANOTHER STENT. ON U/U/U AFTER THE "TRICKY" IMPLANT PATIENT REPORTED SHE "ALMOST DIED" WHICH WAS CLARIFIED AS A NURSE TOLD THE PATIENT THE DOCTOR "SAVED YOUR BACON" WHICH COULD NOT BE FURTHER CLARIFIED. ON 2007/12/23, PATIENT EXPERIENCED THE FEMORAL ARTERY "SHREDDING" DESCRIBED AS FROM BEING "CUT" SEVERAL TIMES DURING THE STENTING AND AS TREATMENT ANOTHER PHYSICIAN PERFORMED AN "ARTIFICIAL FEMORAL ARTERY", WHICH RESULTED IN A HOSPITALIZATION. CONSUMER REPORTED THAT SHE NOW QUESTIONS IF SHE NEEDED THAT MANY STENTS, DESCRIBED AS HAVING 1-2 STENTS PER YEAR DURING THE 5-YEAR TIME PERIOD. BEGINNING ON U/U/U PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN AN ATTEMPTED STENT PLACEMENT WHICH ENDED WITH THE PATIENT BEING TRANSFERRED FROM THE CATH LAB TO HAVE OPEN HEART SURGERY DESCRIBED AS A QUADRUPLE BYPASS ON (B)(6) 2008. ON (B)(6) 2008, FOLLOWING THE QUADRUPLE BYPASS, PATIENT WAS IN THE ICU ON A RESPIRATOR AND THE SURGEON WHO PERFORMED THE BYPASS YELLING AT HER FOR LETTING THE PREVIOUS SURGEON IMPLANT SO MANY STENTS WHICH MADE THE BYPASS ALMOST IMPOSSIBLE. PATIENT ADDITIONALLY REPORTED THAT SHE HAD THOUGHT THAT AFTER THE QUADRUPLE BYPASS ALL OF HER STENTS WOULD HAVE BEEN REMOVED BUT THEY WERE NOT AND SHE NOW HAS A WIRE IN HER CHEST VISIBLE ON X-RAY THAT PROHIBITS HER FROM GOING THROUGH CERTAIN METAL DETECTORS. BEGINNING ON (B)(6) 2014 PATIENT WAS DIAGNOSED WITH "DOUBLE" PNEUMONIA AND HER "O2 SATS" DROPPED, IT WAS NOT CLARIFIED IF PATIENT WAS HOSPITALIZED. PATIENT WAS PRESCRIBED LEVOFLOXACIN AND DEVELOPED AN UNSPECIFIED ALLERGY. AS TREATMENT FOR THE PNEUMONIA, ON (B)(6) 2014 PATIENT BEGAN USING OXYGEN AT NIGHT AND IN (B)(6) 2014 PATIENT WAS PRESCRIBED THE USE OF AN UNSPECIFIED NEBULIZER. PNEUMONIA RESOLVED WITH SEQUELAE OF CONGESTION ON 2014/U/U AND BEING A SHALLOW BREATHER, PATIENT HAS CONTINUED ON OXYGEN AT NIGHT, AND NEBULIZER TREATMENT WAS DISCONTINUED ON (B)(6) 2014. BEGINNING ON (B)(6) 2014, "THE OTHER DAY" PATIENT EXPERIENCED HER BLOOD PRESSURE MEDICATION NOT WORKING DESCRIBED AS A BLOOD PRESSURE OF 200/98, FOR WHICH PHYSICIAN WAS AWARE. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PATIENT WHO PROVIDED DETAILS OF THE DEVICES THAT WERE IMPLANTED. THE PATIENT READ OUT THE DETAILS FROM THE IMPLANT CARDS, ¿(B)(4)¿ 1 CORDIS, IMPLANTED ON (B)(6) 2001, RCA DISTAL, (B)(4). THESE NUMBERS WERE NOT RECOGNIZED BY THE SYSTEM. THEN THERE WERE 2 MORE STENTS, (B)(4) (2), IMPLANTED ON AN UNSPECIFIED DATE PLACED IN THE SVG AND PDA. TWO ADDITIONAL STENTS, (B)(4), WERE PLACED IN THE LAD ON (B)(6) 2003. THERE WERE TWO MORE STENTS, (B)(4), THAT WERE PLACED IN THE PDA ON (B)(6) 2005. THE PATIENT WAS UNABLE TO FOLLOW UP WITH THE PHYSICIAN WHO IMPLANTED THE STENTS AS SHE LIVES IN ANOTHER TOWN. THE PATIENT¿S MEDICAL HISTORY INCLUDED HISTORY OF ALLERGIES: SULFA, HYDROCODONE, CODEINE, PERCODAN, PERCOCET, SMOKING: CURRENT "LIGHT" SMOKER. SMOKES ABOUT 5 CIGARETTES/DAY, HYPERTENSION DIAGNOSED IN 1992 AND IN 1992 THE PATIENT HAD A DOUBLE BYPASS. THE PRODUCTS REMAIN IMPLANTED AND ARE NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD COULD NOT BE PERFORMED ON THE TWO UNKNOWN CYPHER STENTS, (B)(4)/, AS THE PRODUCT DETAILS WERE NOT RECOGNIZED AS VALID. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CORONARY ARTERY DISEASE. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF 10 REPORTS ASSOCIATED WITH THIS PATIENT THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2014-00044, (3003742446-2014-00045- VOIDED AND NO FURTHER REPORTS FORTHCOMING UNDER THIS NUMBER), 3003742446-2014-00049, 3003742446-2014-00050, 3003742446-2014-00051, 3003742446-2014-00052, 3003742446-2014-00053, 3003742446-2014-00054, 3003742446-2014-00055 AND 3003742446-2014-00056.
A CYPHER PATIENT CALLED FOR STENT CARD REPLACEMENT AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON U/U/U, PATIENT EXPERIENCED AN UNKNOWN BLOCKAGE WHICH RESULTED IN TWO UNSPECIFIED BARE METAL STENTS BEING IMPLANTED IN AN UNKNOWN VESSEL ON 2000/U/U, ABOUT 14-YEARS AGO. DURING A 5-YEAR TIME PERIOD FROM ABOUT 2004-2009, PATIENT EXPERIENCED AN UNKNOWN NUMBER OF BLOCKAGES WHICH RESULTED IN 8 OR 9 CYPHER SIROLIMUS DRUG-ELUTING STENTS BEING IMPLANTED IN UNKNOWN VESSELS, DESCRIBED AS MAYBE THE CORONARY ARTERY, BUT PATIENT WAS "NOT REALLY SURE". EACH CYPHER STENT PLACEMENT REQUIRED AN OVERNIGHT STAY UNTIL THE FACILITY BEGAN USING A VASOSEALER WHICH THEN MADE THE PROCEDURES AN OUT-PATIENT PROCEDURE. ON U/U/U, AFTER ONE OF THE CYPHER STENT IMPLANTS, PATIENT'S IMPLANTATION SITE OPENED AND BLED PROFUSELY AND AS TREATMENT THE DOCTOR APPLIED PRESSURE TO THE AREA UNTIL IT STOPPED BLEEDING. THIS WAS REPORTED BY THE PATIENT TO BE PRIOR TO THE USE OF THE "VASOSEALER". ON U/U/U ONE OF THE CYPHER STENT IMPLANTS, WAS "TRICKY" DESCRIBED AS ONE STENT BEING INSERTED THROUGH ANOTHER STENT. ON U/U/U, AFTER THE "TRICKY" IMPLANT PATIENT REPORTED SHE "ALMOST DIED" WHICH WAS CLARIFIED AS A NURSE TOLD THE PATIENT THE DOCTOR "SAVED YOUR BACON" WHICH COULD NOT BE FURTHER CLARIFIED. ON (B)(6) 2007, PATIENT EXPERIENCED THE FEMORAL ARTERY "SHREDDING" DESCRIBED AS FROM BEING "CUT" SEVERAL TIMES DURING THE STENTING AND AS TREATMENT ANOTHER PHYSICIAN PERFORMED AN "ARTIFICIAL FEMORAL ARTERY", WHICH RESULTED IN A HOSPITALIZATION. CONSUMER REPORTED THAT SHE NOW QUESTIONS IF SHE NEEDED THAT MANY STENTS, DESCRIBED AS HAVING 1-2 STENTS PER YEAR DURING THE 5-YEAR TIME PERIOD. BEGINNING ON U/U/U PATIENT EXPERIENCED AN UNKNOWN EVENT WHICH RESULTED IN AN ATTEMPTED STENT PLACEMENT WHICH ENDED WITH THE PATIENT BEING TRANSFERRED FROM THE CATH LAB TO HAVE OPEN HEART SURGERY DESCRIBED AS A QUADRUPLE BYPASS ON (B)(6) 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596023 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| L| R |