CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00420
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- September 7, 2010
- Report Date
- October 28, 2010
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THE STENOSIS WAS JUST PROXIMAL TO THE FIRST SEPTAL BRANCH AND JUST INSIDE THE OSTIUM. A BMW GUIDEWIRE WAS ADVANCED INTO THE DIAGONAL BRANCH OF THE LAD AND THE LESION WAS PRE-DILATED WITH A VOYAGER BALLOON. A 3.5 X 8MM CYPHER STENT WAS IMPLANTED IN THE OSTIUM OF THE LAD WITH THE DISTAL SEGMENT JUST INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENT. THE STENT WAS POST-DILATED WITH AN UNKNOWN BALLOON AT 15ATMS. THERE WAS NO RESIDUAL NARROWING WITHIN THE STENTED SEGMENT. IT WAS ALSO REPORTED THAT AN UNKNOWN CYPHER STENT HAD BEEN PREVIOUSLY IMPLANTED IN THE OBTUSE MARGINAL. THE REPORT STATED THAT WITHIN THE PROXIMAL SEGMENT OF THE OBTUSE MARGINAL VESSEL, THERE WAS A WIDELY PATENT CYPHER STENT WITH NO IN-STENT RESTENOSIS. THERE WAS A 20% STENOSIS JUST PROXIMAL TO THE STENT IN THE VERY PROXIMAL SEGMENT OF THE OBTUSE MARGINAL ARTERY. THE ONGOING OBTUSE MARGINAL ARTERY WAS FREE OF STENOSIS. NO TREATMENT WAS PERFORMED FOR THE CYPHER STENT IN THE OBTUSE MARGINAL. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICES INCLUDE AN UNKNOWN 3X12MM BALLOON CATHETER AND A DURA STAR PTCA DILATATION CATHETER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.
INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR PREVIOUS PERCUTANEOUS CORONARY INTERVENTION, HYPERLIPIDEMIA, HYPERTENSION, ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, SEVERE CORONARY ARTERY DISEASE, AND SEASONAL ALLERGIES. THE INDICATION FOR THE PROCEDURE IS UNKNOWN. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS DE NOVO, 80% STENOSED, 33MM IN LENGTH AND NO CALCIFICATION. THE LESION WAS DIRECT STENTED WITH A 3.5MM X 33MM CYPHER STENT AT 15ATMS. THE STENT WAS POST-DILATED WITH AN UNKNOWN BALLOON FOR OPTIMAL APPOSITION. A NON-TARGET LESION IN THE FIRST DIAGONAL WAS TREATED WITH BALLOON ANGIOPLASTY WITH A DURASTAR BALLOON. THE RESIDUAL STENOSIS FOR BOTH LESIONS WAS 0%. APPROXIMATELY SIX MONTHS LATER THE PATIENT EXPERIENCED UNSTABLE ANGINA AND HAD REPEAT ANGIOGRAPHY WHICH REVEALED RESTENOSIS. THE STENOSIS WAS JUST PROXIMAL TO THE FIRST SEPTAL BRANCH AND JUST INSIDE THE OSTIUM. THE NEW LESION WAS TREATED WITH THE IMPLANT OF A 3.5MM X 8MM CYPHER STENT IN THE OSTIUM OF THE LAD WITH THE DISTAL SEGMENT JUST INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENT. THE STENT WAS POST-DILATED WITH AN UNKNOWN BALLOON AT 15ATMS. THERE WAS NO RESIDUAL NARROWING WITHIN THE STENTED SEGMENT. IT WAS ALSO REPORTED THAT AN UNKNOWN CYPHER STENT HAD BEEN PREVIOUSLY IMPLANTED IN THE OBTUSE MARGINAL AND THAT THE STENT IN THE OM HAD NO RESTENOSIS PATTERN. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. STANDARD PRACTICE DICTATES THAT WHEN IMPLANTING A STENT, THE STENT SHOULD CROSS THE LESION FROM HEALTHY TISSUE TO HEALTHY TISSUE. THIS 33MM LESION WAS TREATED WITH A 33MM STENT. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.
SHE STATED THE PHYSICIAN DESCRIBED THE CYPHER STENT PLACEMENT AS BEING CONTINGENT TO THE CYPHER RX STENT IMPLANTED IN THE MID LAD. CARDIAC CATHETERIZATION REPORT INDICATED THAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY DEMONSTRATED A "CANDY-WRAPPER" LIKE STENOSIS JUST PROXIMAL TO THE PREVIOUSLY IMPLANTED CYPHER STENT. THE STENOSIS WAS JUST PROXIMAL TO THE FIRST SEPTAL BRANCH AND JUST INSIDE THE OSTIUM. A BMW GUIDEWIRE WAS ADVANCED INTO THE DIAGONAL BRANCH OF THE LAD AND THE LESION WAS PRE-DILATED A VOYAGER BALLOON. A 3.5 X 8MM CYPHER STENT WAS IMPLANTED IN THE OSTIUM OF THE LAD WITH THE DISTAL SEGMENT JUST INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENT. THE STENT WAS POST-DILATED WITH AN UNKNOWN BALLOON AT 15ATMS. THERE WAS NO RESIDUAL NARROWING WITHIN THE STENTED SEGMENT. IT WAS ALSO REPORTED THAT AN UNKNOWN CYPHER STENT HAD BEEN PREVIOUSLY IMPLANTED IN THE OBTUSE MARGINAL. THE REPORT STATED THAT WITHIN THE PROXIMAL SEGMENT OF THE OBTUSE MARGINAL VESSEL, THERE WAS A WIDELY PATENT CYPHER STENT WITH NO IN-STENT RESTENOSIS. THERE WAS A 20% STENOSIS JUST PROXIMAL TO THE STENT IN THE VERY PROXIMAL SEGMENT OF THE OBTUSE MARGINAL ARTERY. THE ONGOING OBTUSE MARGINAL ARTERY WAS FREE OF STENOSIS. NO TREATMENT WAS PERFORMED FOR THE CYPHER STENT IN THE OBTUSE MARGINAL. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. CARDIAC CATHETERIZATION REPORT CONFIRMED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT PRONTO ASPIRATION THROMBECTOMY AND IMPLANTATION OF A 3.0X23MM CYPHER STENT IN THE LARGE OBTUSE MARGINAL. CARDIAC CATHETERIZATION REPORT CONFIRMED THAT ON (B)(6) 2009, THE PATIENT FIRST UNDERWENT PRONTO ASPIRATION THROMBECTOMY AND THEN A 3.0X23MM CYPHER STENT WAS IMPLANTED IN THE LARGE OBTUSE MARGINAL. THE STUDY COORDINATOR CONFIRMED THAT THE PRONTO ASPIRATION THROMBECTOMY WAS PERFORMED FOR THROMBOSIS NOTED PRIOR TO CYPHER STENT IMPLANTATION IN THE LARGE OBTUSE MARGINAL. SHE CONFIRMED THERE WAS NO THROMBOSIS AFTER CYPHER STENT IMPLANTATION. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. ADDITIONAL INFORMATION RECEIVED VIA THE ADJUDICATION PROCESS INDICATED ELEVATED ENZYMES ADJUDICATED AS NON Q-WAVE MI. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR PREVIOUS PERCUTANEOUS CORONARY INTERVENTION, HYPERLIPIDEMIA, HYPERTENSION, ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION, SEVERE CORONARY ARTERY DISEASE, AND SEASONAL ALLERGIES. THE INDICATION FOR THE PROCEDURE IS UNKNOWN. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS DE NOVO, 80% STENOSED, 33MM IN LENGTH AND NO CALCIFICATION. THE LESION WAS DIRECT STENTED WITH A 3.5MM X 33MM CYPHER STENT AT 15ATMS. THE STENT WAS POST-DILATED WITH AN UNKNOWN BALLOON FOR OPTIMAL APPOSITION. A NON-TARGET LESION IN THE FIRST DIAGONAL WAS TREATED WITH BALLOON ANGIOPLASTY WITH A DURASTAR BALLOON. THE RESIDUAL STENOSIS FOR BOTH LESIONS WAS 0%. APPROXIMATELY SIX MONTHS LATER, THE PATIENT EXPERIENCED UNSTABLE ANGINA AND HAD REPEAT ANGIOGRAPHY WHICH REVEALED RESTENOSIS. THE STENOSIS WAS JUST PROXIMAL TO THE FIRST SEPTAL BRANCH AND JUST INSIDE THE OSTIUM. THE NEW LESION WAS TREATED WITH THE IMPLANT OF A 3.5MM X 8MM CYPHER STENT IN THE OSTIUM OF THE LAD WITH THE DISTAL SEGMENT JUST INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENT. THE STENT WAS POST-DILATED WITH AN UNKNOWN BALLOON AT 15ATMS. THERE WAS NO RESIDUAL NARROWING WITHIN THE STENTED SEGMENT. IT WAS ALSO REPORTED THAT AN UNKNOWN CYPHER STENT HAD BEEN PREVIOUSLY IMPLANTED IN THE OBTUSE MARGINAL (OM) AND THAT THE STENT IN THE OM HAD NO RESTENOSIS PATTERN. (B)(4): THE PRODUCT REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15079748 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. POST PROCEDURAL MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AS LISTED IN THE INSTRUCTIONS FOR USE (IFU). THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING THE BLOOD FLOW. THE PATIENT'S SIGNIFICANT MEDICAL HISTORY, PROCEDURAL FACTORS, AND LESION CHARACTERISTICS ARE FACTORS LIKELY CONTRIBUTING TO THE EVENT. THERE IS NO INDICATION THAT IT IS RELATED TO ANY DEVICE DESIGN, MANUFACTURING, OR PERFORMANCE ISSUES. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. STANDARD PRACTICE DICTATES THAT WHEN IMPLANTING A STENT, THE STENT SHOULD CROSS THE LESION FROM HEALTHY TISSUE TO HEALTHY TISSUE. THIS 33MM LESION WAS TREATED WITH A 33MM STENT. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.
UPDATED WITH ADDITIONAL INFORMATION. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. HOWEVER, A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15079748 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.
AS REPORTED BY THE (B)(4) STUDY, APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ADDITIONAL INFORMATION WAS RECEIVED VIA THE ADJUDICATION PROCESS THAT INDICATED ELEVATED ENZYMES ADJUDICATED AS NON-Q WAVE MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE MID LAD. A NON-TARGET LESION LOCATED IN THE FIRST DIAGONAL WAS ALSO TREATED. THE TARGET LESION WAS DESCRIBED AS DE NOVO, 80% STENOSED, 33MM IN LENGTH, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. PRE-DILATION WAS NOT PERFORMED. A 3.5X33MM CYPHER RX WAS SUCCESSFULLY IMPLANTED AT 15ATMS. POST-DILATION WAS PERFORMED WITH AN UNKNOWN 3X12MM BALLOON CATHETER AT 10ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED. THE NON-TARGET LESION IN THE FIRST DIAGONAL WAS DESCRIBED AS DE NOVO AND 5MM IN LENGTH. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE LESION WAS TREATED WITH A DURA STAR PTCA BALLOON CATHETER. RESIDUAL STENOSIS WAS 0%. POST-PROCEDURE TIMI FLOW WAS 3. POST-PROCEDURE CK-MB WAS 3.8 (RATION 1.18) AND TROPONIN I WAS 1.6 (RATIO 4.0). ELECTROCARDIOGRAM REPORTED NO NEW MAJOR ST-T WAVE ABNORMALITIES. APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED UNSTABLE ANGINA AND SUBSEQUENTLY UNDERWENT REPEAT CORONARY REVASCULARIZATION OF THE MID LAD. TREATMENT INCLUDED PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS RELATED TO THE INDEX PROCEDURE AND CORDIS PRODUCT. THE STUDY COORDINATOR STATED THE PATIENT UNDERWENT PLACEMENT OF AN UNKNOWN CYPHER STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY SIX MONTHS AFTER THE INDEX PROCEDURE.
AS REPORTED BY THE (B)(4) STUDY, APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT REVASCULARIZATION OF THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE TARGET LESION WAS LOCATED IN THE MID LAD. A NON-TARGET LESION LOCATED IN THE FIRST DIAGONAL WAS ALSO TREATED. THE TARGET LESION WAS DESCRIBED AS DE NOVO, 80% STENOSED, 33MM IN LENGTH, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER AND NON-TORTUOUS. PRE-DILATION WAS NOT PERFORMED. A 3.5X33MM CYPHER RX WAS SUCCESSFULLY IMPLANTED AT 15ATMS. POST-DILATION WAS PERFORMED WITH AN UNKNOWN 3X12MM BALLOON CATHETER AT 10ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED. THE NON-TARGET LESION IN THE FIRST DIAGONAL WAS DESCRIBED AS DE NOVO AND 5MM IN LENGTH. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE LESION WAS TREATED WITH A DURA STAR PTCA BALLOON CATHETER. RESIDUAL STENOSIS WAS 0%. POST-PROCEDURE TIMI FLOW WAS 3. APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED UNSTABLE ANGINA AND SUBSEQUENTLY UNDERWENT REPEAT CORONARY REVASCULARIZATION OF THE MID LAD. TREATMENT INCLUDED PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS RELATED TO THE INDEX PROCEDURE AND CORDIS PRODUCT. THE STUDY COORDINATOR STATED THE PATIENT UNDERWENT PLACEMENT OF AN UNKNOWN CYPHER STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY SIX MONTHS AFTER THE INDEX PROCEDURE. SHE STATED THE PHYSICIAN DESCRIBED THE CYPHER STENT PLACEMENT AS BEING CONTINGENT TO THE CYPHER RX STENT IMPLANTED IN THE MID LAD. CARDIAC CATHETERIZATION REPORT INDICATED THAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY DEMONSTRATED A "CANDY-WRAPPER" LIKE STENOSIS JUST PROXIMAL TO THE PREVIOUSLY IMPLANTED CYPHER STENT.
CARDIAC CATHETERIZATION REPORT CONFIRMED THAT ON (B)(6) 2009, THE PATIENT FIRST UNDERWENT PRONTO ASPIRATION THROMBECTOMY AND THEN A 3.0X23 MM CYPHER STENT WAS IMPLANTED IN THE LARGE OBTUSE MARGINAL. THE STUDY COORDINATOR CONFIRMED THAT THE PRONTO ASPIRATION THROMBECTOMY WAS PERFORMED FOR THROMBOSIS NOTED PRIOR TO CYPHER STENT IMPLANTATION IN THE LARGE OBTUSE MARGINAL. SHE CONFIRMED THERE WAS NO THROMBOSIS AFTER CYPHER STENT IMPLANTATION.
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) | 15079748 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |