CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2014-00048
- Event Type
- Injury
- Date Received
- October 10, 2014
- Report Date
- November 25, 2014
- Manufacturer
- CORDIS CORPORATION
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
A CYPHER PATIENT CALLED FOR REPLACEMENT STENT CARDS AND ADDITIONALLY REPORTED ADVERSE EVENTS. BEGINNING ON U/U/U PATIENT EXPERIENCED SHORTNESS OF BREATH AND LOSS OF STRENGTH GOING UPHILL, WHICH WAS NOT FURTHER CLARIFIED. NO TESTING WAS REPORTED. AS TREATMENT ON (B)(6) 2006 PATIENT HAD 2 CYPHER STENTS IMPLANTED, ONE IN THE RIGHT CORONARY ARTERY (RCA) AND ONE IN THE CIRC. IMMEDIATELY AFTER STENT IMPLANTATION, WHILE "STILL ON THE TABLE" PATIENT BEGAN PLAVIX THERAPY AND PATIENT WAS DISCHARGED HOME THE NEXT DAY, (B)(6) 2006. BEGINNING ON (B)(6) 2006 PATIENT EXPERIENCED AN "ALLERGIC REACTION" TO EITHER HOSPITAL BEDDING OR PLAVIX AND AS TREATMENT PLAVIX THERAPY WAS DISCONTINUED ON (B)(6) 2006. BEGINNING ON U/U/U PATIENT EXPERIENCED SHORTNESS OF BREATH, WHICH HAD WENT AWAY AFTER THE INITIAL STENT IMPLANTATION, AND THEN RETURNED, WHICH WAS DESCRIBED AS THE PATIENT WAS UNSURE HOW REAL THE SHORTNESS OF BREATH WAS OR IF IT WAS PSYCHOSOMATIC BECAUSE OF STENT IMPLANTATION, AND POSSIBLY HE WAS NERVOUS. AS TREATMENT, PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) AND WAS DISCHARGED HOME. AS FURTHER TREATMENT ON (B)(6) PATIENT HAD AN ANGIOPLASTY WHICH RESULTED IN A UNSPECIFIED STENT BEING PLACED IN AN UNSPECIFIED VESSEL ON (B)(6) 2007. PATIENT WAS IN THE HOSPITAL OVERNIGHT AFTER THE STENT IMPLANTATION. BEGINNING ON (B)(6) 2007 PATIENT EXPERIENCED AN ALLERGIC REACTION WITH A RASH AND ITCHY SKIN. NO TREATMENT WAS REPORTED. BEGINNING ON U/U/U PATIENT EXPERIENCED AN INJURY AFTER EXERCISING DESCRIBED AS A VERY BAD BACK PROBLEM. AS TREATMENT ON (B)(6) 2013 PATIENT HAD AN UNSPECIFIED BACK SURGERY AND HE WAS DISCHARGED HOME AFTER 4 DAYS. BEGINNING ON (B)(6) 2013 PATIENT EXPERIENCED AN ALLERGIC REACTION WITH A RASH AND ITCHY SKIN, NO TREATMENT WAS REPORTED. BEGINNING ON (B)(6) 2013 PATIENT DEVELOPED AN INFECTION INSIDE THE BACK SURGERY INCISION. AS TREATMENT PATIENT HAD A PICC LINE PLACED ON U/U/U AND BEGAN 3 WEEKS OF PENICILLIN THERAPY WHICH WAS FOLLOWED BY 3 WEEKS OF VANCOMYCIN THERAPY AT HOME. AS TREATMENT PATIENT HAD A PICC LINE PLACED ON U/U/U AND BEGAN 3 WEEKS OF PENICILLIN THERAPY WHICH WAS FOLLOWED BY 3 WEEKS OF VANCOMYCIN THERAPY AT HOME. BEGINNING ON (B)(6), DURING PICC LINE USE WITH ANTIBIOTICS, PATIENT EXPERIENCED A HIGH LEVEL OF POTASSIUM DESCRIBED AS "BORDERLINE HIGH" AND AS TREATMENT HIS PRE-EXISTING DOSE OF LISINOPRIL WAS DISCONTINUED ON (B)(6). PATIENT ADDITIONALLY REPORTED ATTENDING CARDIAC REHAB AT GOOD SAMARITAN MEDICAL CENTER, DATES OF REHAB WERE NOT OBTAINED. NO FURTHER INFORMATION WAS AVAILABLE. COMMENTS: CYPHER STENT IN THE RCA: PRODUCT CODE H739CXS233003W. CYPHER STENT IN THE CIRC: PRODUCT CODE H739CXS193003. ADDITIONAL DETAILS FROM THE CUSTOMER INDICATES THAT THE THIRD STENT IS ALSO A CYPHER BUT THE PATIENT IS NOT SURE WHERE EXACTLY IT WAS PLACED. NO TREATMENT WAS PROVIDED FOR THE ALLERGIC REACTIONS. HE WAS TOLD THAT HE IS ALLERGIC TO PLAVIX. HE THINKS HE'S ALSO ALLERGIC TO HOSPITAL BEDDING BECAUSE HE KEEPS HAVING RASHES AFTER BEING HOSPITALIZED. THE DEVICES REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY REVIEW OF THE CXS23300 SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS, RASH AND ALLERGIC REACTIONS ARE 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 2 PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 3003742446-2014-00047 AND 3003742446-2014-00048.
THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 3003742446-2014-00047 AND 3003742446-2014-00048.
A CYPHER PATIENT CALLED FOR REPLACEMENT STENT CARDS AND ADDITIONALLY REPORTED ADVERSE EVENTS. BEGINNING ON U/U/U PATIENT EXPERIENCED SHORTNESS OF BREATH AND LOSS OF STRENGTH GOING UPHILL, WHICH WAS NOT FURTHER CLARIFIED. NO TESTING WAS REPORTED. AS TREATMENT ON (B)(6) 2006 PATIENT HAD 2 CYPHER STENTS IMPLANTED, ONE IN THE RIGHT CORONARY ARTERY (RCA) AND ONE IN THE CIRC. IMMEDIATELY AFTER STENT IMPLANTATION, WHILE "STILL ON THE TABLE" PATIENT BEGAN PLAVIX THERAPY AND PATIENT WAS DISCHARGED HOME THE NEXT DAY, (B)(6) 2006. BEGINNING ON (B)(6) 2006 PATIENT EXPERIENCED AN "ALLERGIC REACTION" TO EITHER HOSPITAL BEDDING OR PLAVIX AND AS TREATMENT PLAVIX THERAPY WAS DISCONTINUED ON (B)(6) 2006. BEGINNING ON U/U/U PATIENT EXPERIENCED SHORTNESS OF BREATH, WHICH HAD WENT AWAY AFTER THE INITIAL STENT IMPLANTATION, AND THEN RETURNED, WHICH WAS DESCRIBED AS THE PATIENT WAS UNSURE HOW REAL THE SHORTNESS OF BREATH WAS OR IF IT WAS PSYCHOSOMATIC BECAUSE OF STENT IMPLANTATION, AND POSSIBLY HE WAS NERVOUS. AS TREATMENT, PATIENT WENT TO THE EMERGENCY ROOM ON U/U/U AND WAS DISCHARGED HOME. AS FURTHER TREATMENT ON U/U/U PATIENT HAD AN ANGIOPLASTY WHICH RESULTED IN A UNSPECIFIED STENT BEING PLACED IN AN UNSPECIFIED VESSEL ON (B)(6) 2007. PATIENT WAS IN THE HOSPITAL OVERNIGHT AFTER THE STENT IMPLANTATION. BEGINNING ON (B)(6) 2007 PATIENT EXPERIENCED AN ALLERGIC REACTION WITH A RASH AND ITCHY SKIN. NO TREATMENT WAS REPORTED. BEGINNING ON U/U/U PATIENT EXPERIENCED AN INJURY AFTER EXERCISING DESCRIBED AS A VERY BAD BACK PROBLEM. AS TREATMENT ON (B)(6) 2013 PATIENT HAD AN UNSPECIFIED BACK SURGERY AND HE WAS DISCHARGED HOME AFTER 4 DAYS. BEGINNING ON (B)(6) 2013 PATIENT EXPERIENCED AN ALLERGIC REACTION WITH A RASH AND ITCHY SKIN, NO TREATMENT WAS REPORTED. BEGINNING ON (B)(6) 2013 PATIENT DEVELOPED AN INFECTION INSIDE THE BACK SURGERY INCISION. AS TREATMENT PATIENT HAD A PICC LINE PLACED ON U/U/U AND BEGAN 3 WEEKS OF PENICILLIN THERAPY WHICH WAS FOLLOWED BY 3 WEEKS OF VANCOMYCIN THERAPY AT HOME. BEGINNING ON U/U/U, DURING PICC LINE USE WITH ANTIBIOTICS, PATIENT EXPERIENCED A HIGH LEVEL OF POTASSIUM DESCRIBED AS "BORDERLINE HIGH" AND AS TREATMENT HIS PRE-EXISTING DOSE OF LISINOPRIL WAS DISCONTINUED ON U/U/U. PATIENT ADDITIONALLY REPORTED ATTENDING CARDIAC REHAB AT GOOD SAMARITAN MEDICAL CENTER, DATES OF REHAB WERE NOT OBTAINED. NO FURTHER INFORMATION WAS AVAILABLE. COMMENTS: CYPHER STENT IN THE RCA: PRODUCT H739CXS233003W. CYPHER STENT IN THE CIRC: PRODUCT H739CXS19300.3 ADDITIONAL DETAILS FROM THE CUSTOMER INDICATES THAT THE THIRD STENT IS ALSO A CYPHER BUT THE PATIENT IS NOT SURE WHERE EXACTLY IT WAS PLACED. NO TREATMENT WAS PROVIDED FOR THE ALLERGIC REACTIONS. HE WAS TOLD THAT HE IS ALLERGIC TO PLAVIX. HE THINKS HE'S ALSO ALLERGIC TO HOSPITAL BEDDING BECAUSE HE KEEPS HAVING RASHES AFTER BEING HOSPITALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640592 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS CORPORATION | CXS23300 | A0406154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| L| R |