CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00372
- Event Type
- Injury
- Date Received
- October 25, 2010
- Date of Event
- March 26, 2010
- Report Date
- September 28, 2010
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. DISSECTIONS MAY LEAD TO THROMBUS FORMATION. THE CHEST PAIN AND ELEVATED ENZYMES EXPERIENCED BY THE PATIENT POST PROCEDURE ARE LIKELY TO BE RELATED TO THE DISSECTION AND THROMBUS COMPLICATIONS EXPERIENCED DURING THE PROCEDURE AS WELL AS THE MULTIPLE STENTING. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE PATIENT, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. MULTIPLE ATTEMPTS WERE MADE TO DETERMINE THE REASON FOR THE INACCURATE PLACEMENT EXPERIENCED WITH ONE STENT WITHOUT SUCCESS, THEREFORE IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THIS EVENT. ADDITIONAL INFORMATION WILL BE REPORTED AS IT BECOMES AVAILABLE. NEITHER THE DHR REPORTS NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF FIVE (5) REPORTS SUBMITTED FOR RELATED EVENTS OCCURRING IN THE SAME PATIENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00372, 3003742446-2010-00373, 3003742446-2010-00374, 3003742446-2010-00375, AND 3003742446-2010-00377.
ADDENDUM ((B)(6) 2012): CEC ADJUDICATION MINUTES WERE RECEIVED ON (B)(6) 2012. AS PER THE PREVIOUS REPORT, THE PATIENT'S CARDIAC ENZYMES WERE IN NORMAL RANGE PRE-PROCEDURE, BUT THEY WERE ELEVATED POST INDEX PROCEDURE. AS PER THE ADJUDICATION REPORT, THE ECG CORE LAB REPORTED RECENT/ACUTE INTERMITTENT HIGH LATERAL ST ELEVATION, RECENT/ACUTE INTERMITTENT INFERIOR ST DEPRESSION AND NO NEW Q WAVES NOTING INADEQUATE TRACING QUALITY DUE TO A SEVERE ARTIFACT. THE SITE DID NOT REPORT AN EVENT OF MI, BUT THIS ELEVATION WAS LATER DIAGNOSED AS A PROTOCOL DEFINED NON-Q WAVE MI AND PERIPROCEDURAL MI BASED ON THE RECEIVED ADJUDICATION MINUTES. PLEASE NOTE THAT PREVIOUSLY REPORTED ENZYMES ELEVATION WAS REMOVED FROM THE FILE AND THE CODE FOR MI WAS ADDED BASED ON THE ADJUDICATION MINUTES. PLEASE NOTE THAT THE TYPE OF REPORTABLE EVENT HAS BEEN CHECKED AS A SERIOUS INJURY. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF FIVE REPORTS SUBMITTED FOR RELATED EVENT OCCURRED IN THE SAME PATIENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00372, 3003742446-2010-00373, 3003742446-2010-00374, 3003742446-2010-00375, AND 3003742446-2010-00377.
(CONCOMITANT PRODUCTS): 2.5 X 8MM CYPHER STENT, 2.5 X 6MM PTCA BALLOON, 2.5 X 15MM NON-CORDIS BALLOON, 2.75 X 33MM CYPHER STENT, 3.0 X 23MM CYPHER STENT, 3.0 X 20MM PTCA BALLOON, 2.25 X 8MM CYPHER STENT, 3.0 X 20MM PTCA BALLOON, 2.5 X 8MM CYPHER STENT, 2.5 X 6MM PTCA BALLOON.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF FIVE (5) REPORTS SUBMITTED FOR RELATED EVENTS OCCURRING IN THE SAME PATIENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00372, 3003742446-2010-00373, 3003742446-2010-00374, 3003742446-2010-00375, AND 3003742446-2010-00377.
COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED A PERI-PROCEDURAL MI, ARTERIAL DISSECTION AND THROMBOSIS DURING THE INDEX PROCEDURE. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING DYSLIPIDEMIA, HYPERTENSION, CLASS IV HEART FAILURE, DIABETES, ANEMIA AND DIALYSIS DEPENDANT RENAL FAILURE. THE INDICATION FOR THE INDEX PROCEDURE WAS A POSITIVE FUNCTIONAL STUDY WITHOUT ANGINA. ANGIOGRAPHY REVEALED A 80% STENOSIS IN THE DISTAL LAD AND A 70% STENOSIS IN THE PROXIMAL 1ST DIAGONAL. IN (B)(6) 2010, THE INDEX PROCEDURE WAS PERFORMED TO TREAT TWO TARGET LESIONS. THE FIRST LESION TREATED WAS THE 1ST DIAGONAL. PRE-DILATION AND IMPLANTATION OF ONE STUDY STENT WAS SUCCESSFULLY COMPLETED. THE SECOND LESION TREATED WAS IN THE DISTAL LAD. ATTEMPTS TO ADVANCE THE STUDY STENT WERE MET WITH RESISTANCE; SUCCESSFUL PASSAGE AND IMPLANTATION OF THE STUDY STENT WERE COMPLETED AFTER THE GUIDING CATHETER WAS CHANGED. AN ADDITIONAL STUDY STENT WAS THEN ADVANCED TO A MORE PROXIMAL PORTION OF THE DISEASED SEGMENT, IMPLANTED AND POST-DILATED. A GAP WAS NOTED BETWEEN THE TWO STENTS AND A THIRD STENT WAS IMPLANTED TO CLOSE THE GAP. DURING DELIVERY OF THE THIRD STENT THE PATIENT EXPERIENCED CHEST PAIN WITH LATERAL WALL ST ELEVATIONS. ANGIOGRAPHY REVEALED ACUTE CLOSURE OF THE 1ST DIAGONAL BRANCH AT ITS ORIGIN. THE THIRD LAD STENT WAS POST DILATED. AT THIS POINT, THE DIAGONAL BRANCH WAS TREATED WITH POBA AND BLOOD FLOW WAS RESTORED IN THE VESSEL. HEPARIN WAS USED BECAUSE OF CONCERN OF ACUTE THROMBOSIS AND THE ADEQUACY OF DELIVERY OF THE BIVALIRUDIN. THE PATIENT CONTINUED TO HAVE CHEST PAIN DESPITE TIMI 3 FLOW THROUGHOUT THE WHOLE VESSEL. IV METOPROLOL AND NTG WERE GIVEN AND THE ST SEGMENT ELEVATION RESOLVED. FOR THE TARGET LESION IN THE 1ST DIAGONAL, THE CORE LAB REPORTED 31% RESIDUAL STENOSIS, NO DISSECTION AND TIMI 3 FLOW WITH THE FOLLOWING COMMENT. "TRANSIENT ABRUPT CLOSURE MOST LIKELY DUE TO A VESSEL DISSECTION. GOOD FINAL RESULT". FOR THE TARGET LESION IN THE DISTAL LAD, THE CORE LAB REPORTED A 19% RESIDUAL STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. AT THE BEGINNING OF THE PROCEDURE THE CK WAS 85, THE CKMB WAS 2.9 AND THE TROPONIN WAS <0.01. POST PROCEDURE THE CK WAS 1076, THE CKMB WAS 225.5 AND THE TROPONIN WAS 22.51. THE NEXT SET OF ENZYMES WAS CK 1276, THE CKMB 254.3 AND TROPONIN WAS 43.23. THE NEXT SET OF ENZYMES WAS CK 1331, THE CKMB 279.8 AND TROPONIN WAS 46.2. THE FOLLOWING SET WAS THE CK WAS 1022, THE CKMB WAS 200.3 AND THE TROPONIN WAS 45.17. THE CORE ECG LAB REPORTED RECENT/ACUTE INTERMITTENT HIGH LATERAL ST ELEVATION, RECENT/ACUTE INTERMITTENT INFERIOR ST DEPRESSION AND NO NEW Q WAVES, NOTING INADEQUATE TRACING QUALITY DUE TO ARTIFACT. THE SITE DID NOT REPORT AN MI. THE CEC ADJUDICATION COMMITTEE HAS DEEMED THIS EVENT AN ARC PERI-PROCEDURE PCI THUS A CODE FOR MI WAS ADDED TO THE FILE. THE PATIENT WAS DISCHARGED THREE DAYS POST INDEX PROCEDURE ON DUAL ANTE-PLATELET THERAPY. THE CYPHER STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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 15107327 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION 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 OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. 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. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF FIVE REPORTS SUBMITTED FOR RELATED EVENT OCCURRED IN THE SAME PATIENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2010-00372, 3003742446-2010-00373, 3003742446-2010-00374, 3003742446-2010-00375, AND 3003742446-2010-00377.
THIS PATIENT WAS ADMITTED FOR ANGIOGRAPHY DUE TO POSITIVE STRESS TEST RESULTS. PRE-PROCEDURE THE PATIENT'S (B)(6). ANGIOGRAPHY REVEALED A 70%, 3MM, HEAVILY CALCIFIED TYPE A DE NOVO LESION IN THE PROXIMAL SEGMENT OF THE 1ST DIAGONAL, AND A 60%, HEAVILY CALCIFIED, TYPE C, DE NOVO LESION IN THE DISTAL LAD. THE DIAGONAL WAS TREATED BY DIRECT STENTING WITH A 2.5 X 8MM CYPHER STENT DEPLOYED TO 14 ATMS. THE STENT WAS POST DILATED PER STANDARD PROCEDURE WITH A 2.5 X 6MM PTCA BALLOON. THERE WAS A 10% RESIDUAL POST STENTING. THE DISTAL LAD WAS THEN TREATED. THE LESION WAS PRE-DILATED WITH A 2.5 X 15MM NON-CORDIS BALLOON INFLATED TO 18 ATMS. A 2.75 X 33MM CYPHER STENT WAS ADVANCED TO THE TARGET SITE AND WAS DEPLOYED TO 12 ATMS. IT WAS REPORTED THAT THE STENT WAS NOT DEPLOYED AT THE INTENDED SITE AND DID NOT ADEQUATELY COVER THE LESION. A 3.0 X 23MM CYPHER STENT WAS THEN PLACED PROXIMAL TO, BUT NOT OVERLAPPING THE FIRST CYPHER STENT. THIS STENT WAS DEPLOYED TO 12 ATMS. ADDITIONALLY, THE STENTS WERE NOT FULLY EXPANDED; THEREFORE THE STENT WAS POST DILATED WITH A 3.0 X 20MM PTCA BALLOON INFLATED TO 14 ATMS. A 2.25 X 8MM CYPHER STENT WAS THEN POSITIONED TO COVER THE GAP BETWEEN THE FIRST AND SECOND STENT IMPLANTED AND WAS DEPLOYED TO 18 ATMS. FINALLY THE 2.25 X 8MM STENT WAS POST DILATED PER STANDARD PROCEDURE WITH A 3.0 X 20MM PTCA BALLOON INFLATED TO 16 ATMS. AT THAT TIME, THE PHYSICIAN NOTED A THROMBUS FORMATION AND EDGE DISSECTION AT THE PROXIMAL EDGE OF THE PREVIOUSLY IMPLANTED 2.5 X 8MM CYPHER STENT IN THE DIAGONAL BRANCH. A 2.5 X 8MM CYPHER STENT WAS PLACED OVERLAPPING AND PROXIMAL TO THE STENT AND WAS DEPLOYED TO 14 ATMS. THE STENT WAS POST DILATED WITH A 2.5 X 6MM PTCA BALLOON INFLATED TO 14 ATMS TO SEAL THE EDGE DISSECTION AND REESTABLISH FLOW. POST PROCEDURE, THE PATIENT EXPERIENCED A RISE IN CARDIAC ENZYMES.
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) | 15107327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Life Threatening| R |