CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2010-00477
- Event Type
- Injury
- Date Received
- December 20, 2010
- Date of Event
- March 1, 2010
- Report Date
- April 8, 2010
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
THE PHYSICIAN THEN REWIRED THE DIAGONAL BRANCH ULTIMATELY USING A PILOT WIRE AND PERFORMED KISSING BALLOON ANGIOPLASTY WITH THE 3.0 CYPHER BALLOON PREVIOUSLY USED AND THE PREVIOUSLY USED 2.5 VOYAGER BALLOON, BOTH DEPLOYED TO 10 ATMOSPHERES FOR 30 SECONDS RESULTING WITH A 20% TO 30% RESIDUAL LESION IN THE OSTIUM OF THE DIAGONAL BRANCH AND NO RESIDUAL DISEASE IN THE LAD. DURING BALLOON INFLATION, THE PATIENT DID DEVELOP HER TYPICAL ANGINA CHEST PAIN WHICH RESOLVED UPON COMPLETION OF BALLOON DEFLATION AND UPON COMPLETION OF THE PROCEDURE, HEMODYNAMICS WERE STABLE AND THERE WAS NO ECG CHANGES OR RESIDUAL CHEST PAIN. THE PHYSICIAN THEN REWIRED THE DIAGONAL BRANCH ULTIMATELY USING A PILOT WIRE AND PERFORMED KISSING BALLOON ANGIOPLASTY WITH THE 3.0 CYPHER BALLOON PREVIOUSLY USED AND THE PREVIOUSLY USED 2.5 VOYAGER BALLOON, BOTH DEPLOYED TO 10 ATMOSPHERES FOR 30 SECONDS RESULTING WITH A 20% TO 30% RESIDUAL LESION IN THE OSTIUM OF THE DIAGONAL BRANCH AND NO RESIDUAL DISEASE IN THE LAD. DURING BALLOON INFLATION, THE PATIENT DID DEVELOP HER TYPICAL ANGINA CHEST PAIN WHICH RESOLVED UPON COMPLETION OF BALLOON DEFLATION AND UPON COMPLETION OF THE PROCEDURE, HEMODYNAMICS WERE STABLE AND THERE WAS NO ECG CHANGES OR RESIDUAL CHEST PAIN. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, THE PATIENT RETURNED WITH RECURRENT CHEST PAIN WITH AN ABNORMAL STRESS TEST SUGGESTING ANTEROLATERAL ISCHEMIA. ANGIOGRAPHY SHOWED THAT THE PREVIOUSLY STENTED LARGE DIAGONAL BRANCH AS WELL AT ITS OSTIAL SEGMENT AT THE INTERSECTION OF THE LAD AND THE DIAGONAL BRANCH OF THE PERIOSTEUM SEGMENT WAS A DISCRETE 90% LESION WHICH THE PHYSICIAN BELIEVES EXPLAINS THE UNDERLYING ISCHEMIA. TO TREAT THE LESION AN EBU CATHETER WAS USED TO ENGAGE A 0.014 COUGAR WIRE WAS ADVANCED DOWN THE DIAGONAL BRANCH. BALLOON ANGIOPLASTY WAS PERFORMED WITH A 2.5 X 12 MM SPRINTER BALLOON DEPLOYED TO 12 ATMOSPHERES FOR 30 SECONDS AND THEN ULTIMATELY PLACED A 2.5 X 12 MM ENDEAVOR DRUG-ELUTING STENT FROM THE LAD DOWN INTO THE DIAGONAL BRANCH, COMPLETELY COVERING OVER THE OSTIUM, AND THEN POST DILATED THIS WITH A 2.5 X 12 MM NONCOMPLIANT NC SPRINTER BALLOON, KISSING BALLOON ANGIOPLASTY WAS PERFORMED AFTER I REWIRED THE LAD WITH A SECOND COUGAR WIRE AND SIMULTANEOUSLY INFLATED A 3-0 BALLOON IN THE LAD AND A 2.5 NONCOMPLIANT SPRINTER BALLOON IN THE DIAGONAL BRANCH. BOTH TO 10 ATMOSPHERES FOR 30 SECONDS RESULTING IN ZERO % RESIDUAL STENOSIS AND TIMI-3 FLOW DISTALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH EXCELLENT RESULTS. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2010-00477 AND 3003742446-2010-00478.
THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 3003742446-2010-00477 AND 3003742446-2010-00478.
THE EMAIL RECEIVED VIA THE (B)(4) STUDY INDICATED THAT DURING STENTING OF THE INDEX LESION PLAQUE SHIFT OCCURRED AFTER DEPLOYING THE STUDY (CXS08250/ LOT 15075500) STENT PROMPTING THE PHYSICIAN TO DEPLOY A SECOND CYPHER STENT. IT WAS REPORTED THAT DURING POST DILATION THE PATIENT HAD HER TYPICAL CHEST PAIN WHICH RESOLVED WITH BALLOON DEFLATION. IN ADDITION TO ELEVATED PRE-PROCEDURE TROPONIN, POST PROCEDURE ELEVATION WAS DOCUMENTED. APPROXIMATELY FOUR MONTHS POST PROCEDURE A 90% RESTENOSIS WAS DISCOVERED AT THE STENTED AREA. THIS WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A NONCORDIS STENT. THIS (B)(6) FEMALE WITH A HISTORY OF UNSTABLE ANGINA, HYPERLIPIDEMIA, AND FAMILY HISTORY OF CORONARY ARTERY DISEASE WAS ENROLLED IN THE (B)(4) STUDY. THE INDICATION FOR THE INTERVENTION WAS UNSTABLE ANGINA AND RECENT POSITIVE FUNCTIONAL TEST FOR ISCHEMIA. THE PATIENT HAD BEEN ADMITTED FOR CHEST PAIN AND SHORTNESS OF BREATH BUT WAS RULED OUT FOR MI. CORONARY ANGIOGRAPHY WAS ORDERED AFTER ECHOCARDIOGRAM REVEALED DECREASED EJECTION FRACTION WITH WALL MOTION ABNORMALITIES. PRIOR TO INDEX PROCEDURE, THE PATIENT HAD ELEVATED TROPONIN T OF 0.05 NG/ML (UPPER RANGE OF NORMAL IS 0.01 NG/ML) AND WAS STILL ELEVATED AT PRE-INDEX PROCEDURE TIME. POST PROCEDURE TROPONIN T WAS 0.06 NG/ML. THERE WAS NO TREATMENT OTHER THAN ROUTINE POST STENT MEDICATIONS. THE TARGET LESION LOCATIONS WERE THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE 1ST DIAGONAL BRANCH. PER THE IFU, THE SAFETY AND EFFECTIVENESS OF IMPLANTATION TO TREAT OSTIAL/BIFURCATION LESION HAS NOT BEEN ESTABLISHED. A 0.014 ASAHI SOFT WIRE WAS ADVANCED DOWN THE DIAGONAL VESSEL AND OVER THIS A 2.5 X 12 MM VOYAGER BALLOON WAS ADVANCED AND DEPLOYED 1 TIME TO 10 ATMOSPHERES FOR 30 SECONDS. THERE WAS STILL A SIGNIFICANT RESIDUAL LESION PROMPTING THE PHYSICIAN TO IMPLANT A 2.5 X 8 MM CYPHER DRUG-ELUTING STENT JUST AT THE OSTIAL LEVEL. THERE WAS ENOUGH SHIFTING OF PLAQUE INTO THE LAD THAT THE PHYSICIAN FELT A SECOND STENT WAS NECESSARY IN THE LAD. THEREFORE, OVER NEW ASAHI SOFT WIRE HE ADVANCED A 3.0 X 13 MM CYPHER DRUG-ELUTING STENT IN THE LAD OVERLAPPING THE SITE OF THE DIAGONAL BRANCH AND DEPLOYED IT TO 14 ATMOSPHERES FOR 30 SECONDS. THE DIAGONAL BRANCH WAS THEN REWIRED ULTIMATELY USING A PILOT WIRE AND PERFORMED KISSING BALLOON ANGIOPLASTY WITH THE 3.0 CYPHER BALLOON PREVIOUSLY USED AND THE PREVIOUSLY USED 2.5 VOYAGER BALLOON, BOTH DEPLOYED TO 10 ATMOSPHERES FOR 30 SECONDS RESULTING WITH A 20% TO 30% RESIDUAL LESION IN THE OSTIUM OF THE DIAGONAL BRANCH AND NO RESIDUAL DISEASE IN THE LAD. DURING BALLOON INFLATION, THE PATIENT DID DEVELOP HER TYPICAL ANGINA CHEST PAIN WHICH RESOLVED UPON COMPLETION OF BALLOON DEFLATION AND UPON COMPLETION OF THE PROCEDURE, HEMODYNAMICS WERE STABLE AND THERE WERE NO ECG CHANGES OR RESIDUAL CHEST PAIN. IT WAS REPORTED THAT THERE WAS NO OTHER TREATMENT OTHER THAN ROUTINE POST STENT MEDICATIONS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, THE PATIENT RETURNED WITH RECURRENT CHEST PAIN WITH AN ABNORMAL STRESS TEST SUGGESTING ANTEROLATERAL ISCHEMIA. ANGIOGRAPHY SHOWED THAT THE PREVIOUSLY STENTED LARGE DIAGONAL BRANCH AS WELL AT ITS OSTIAL SEGMENT AT THE INTERSECTION OF THE LAD AND THE DIAGONAL BRANCH OF THE PERIOSTEUM SEGMENT WAS A DISCRETE 90% LESION WHICH THE PHYSICIAN BELIEVES EXPLAINS THE UNDERLYING ISCHEMIA. TO TREAT THE LESION AN EBU CATHETER WAS USED TO ENGAGE AND A 0.014 COUGAR WIRE WAS ADVANCED DOWN THE DIAGONAL BRANCH. BALLOON ANGIOPLASTY WAS PERFORMED WITH A 2.5 X 12 MM SPRINTER BALLOON DEPLOYED TO 12 ATMOSPHERES FOR 30 SECONDS AND THEN ULTIMATELY PLACED A 2.5 X 12 MM ENDEAVOR DRUG-ELUTING STENT FROM THE LAD DOWN INTO THE DIAGONAL BRANCH, COMPLETELY COVERING OVER THE OSTIUM. THIS WAS THEN POST DILATED WITH A 2.5 X 12 MM NONCOMPLIANT NC SPRINTER BALLOON. KISSING BALLOON ANGIOPLASTY WAS PERFORMED AFTER REWIRING THE LAD WITH A SECOND COUGAR WIRE WITH SIMULTANEOUS INFLATION OF A 3-0 BALLOON IN THE LAD AND A 2.5 NONCOMPLIANT SPRINTER BALLOON IN THE DIAGONAL BRANCH. BOTH WERE INFLATED TO 10 ATMOSPHERES FOR 30 SECONDS RESULTING IN ZERO % RESIDUAL STENOSIS AND TIMI-3 FLOW DISTALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH EXCELLENT RESULTS. THE STENTS REMAIN IMPLANTED AND THEREFORE ARE NOT AVAILABLE FOR EVALUATION AND TESTING. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. LUMEN ENLARGEMENT DURING CORONARY STENTING RESULTS FROM VESSEL EXPANSION AND AXIAL REDISTRIBUTION OF ATHEROMATOUS PLAQUE ALONG THE STENTED SEGMENT AND PROXIMAL AND DISTAL SEGMENTS POTENTIALLY LEADING TO DISPLACEMENT SHIFT OF PLAQUE BEYOND THE BORDERS OF THE STENT. ADDITIONALLY IT PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO DISPLACEMENT SHIFT OF PLAQUE RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. THIS ACTION CAN EXHIBIT ITSELF AS CHEST PAIN, EKG CHANGES AND CARDIAC ENZYMES INCREASE. PCI OF LESIONS LOCATED NEXT TO A CORONARY BIFURCATION ALMOST INEVITABLY CAUSES PLAQUE REDISTRIBUTION IN THE SIDE BRANCHES. COMMON TECHNIQUES TO PREVENT PLAQUE SHIFTING DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. IN ADDITION, AS REPORTED DISRUPTION OF BLOOD FLOW DURING BALLOON INFLATION LIKELY RESULTED IN THE REPORTED CHEST PAIN WHICH RESOLVED WITH BALLOON DEFLATION. THIS IS A NORMAL AND PROCEDURAL OCCURRENCE. BASED ON THE INFORMATION PROVIDED, THERE ARE POSSIBLE PATIENT, VESSEL AND INHERENT RISK OF PROCEDURE FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. PATIENT FACTORS, VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS ALONG WITH PROGRESSION OF EXISTING CORONARY ARTERY DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED IN-STENT RESTENOSIS. BASED ON THE AVAILABLE INFORMATION AND THE DEVICE HISTORY RECORDS REVIEW, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENTS; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 3003742446-2010-00477 AND 3003742446-2010-00478.
THE EMAIL RECEIVED FOR (B)(4) STUDY INDICATED THAT DURING STENTING OF THE INDEX LESION PLAQUE SHIFT OCCURRED AFTER DEPLOYING THE (CXS08250/ LOT 15075500) STENT PROMPTING THE PHYSICIAN TO DEPLOY A SECOND CYPHER STENT. APPROXIMATELY FOUR MONTHS POST PROCEDURE, A 90% RESTENOSIS WAS DISCOVERED AT THE STENTED AREA. THIS PATIENT IS A (B)(6) FEMALE WHO WAS ENROLLED IN (B)(4) STUDY. THE INDICATION FOR THE INTERVENTION WAS UNSTABLE ANGINA AND RECENT POSITIVE FUNCTIONAL TEST FOR ISCHEMIA. THE TARGET LESION LOCATIONS WERE THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE 1ST DIAGONAL BRANCH. A 0.014 ASAHI SOFT WIRE WAS ADVANCED DOWN THE DIAGONAL VESSEL AND OVER THIS A 2.5 X 12 MM VOYAGER BALLOON WAS ADVANCED AND DEPLOYED 1 TIME TO 10 ATMOSPHERES FOR 30 SECONDS. THERE WAS STILL A SIGNIFICANT RESIDUAL LESION PROMPTING THE PHYSICIAN TO IMPLANT A 2.5 X 8 MM CYPHER DRUG-ELUTING STENT JUST AT THE OSTIAL LEVEL. THERE WAS ENOUGH SHIFTING OF PLAQUE INTO THE LAD THAT THE PHYSICIAN FELT A SECOND STENT WAS NECESSARY IN THE LAD. THEREFORE, OVER NEW ASAHI SOFT WIRE HE ADVANCED A 3.0 X 13 MM CYPHER DRUG-ELUTING STENT IN THE LAD OVERLAPPING THE SITE OF THE DIAGONAL BRANCH AND DEPLOYED IT TO 14 ATMOSPHERES FOR 30 SECONDS.
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) | NA | 15076317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization| L| R | ASASHI SOFT WIRE, VOYAGER BALLOON |