CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 9616099-2011-00667
Event Type: Injury
Date Received: August 24, 2011
Date of Event: August 27, 2010
Report Date: August 4, 2011
Manufacturer: CORDIS DE MEXICO
Product Code: NIQ
PMA / PMN Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

HE ADVANCED SUPRSOFT GUIDEWIRE TO CROSS THROUGH THE LESION. THEN HE USED 2.5 X 20MM BALLOON (AVITA) TO PRE-DILATE DISTAL LESION AT 14ATM FOR 10 SECS. AFTER THAT, THE PHYSICIAN IMPLANTED 3.0 X 28MM STENT AT DISTAL STENOSIS SEGMENT AND 3.5 X 23MM STENT AT PROXIMAL STENOSIS SEGMENT. THE DEPLOYMENT PRESSURE OF THESE TWO STENTS WAS 18ATM. THESE TWO STENTS WERE CONNECTED TOGETHER. SO THE PHYSICIAN USED THE STENT'S BALLOON TO POST-DILATE THE CONNECTING PART OF THESE 2 STENTS AT 10ATM FOR 5 SECS. THE STENT WAS POST-DILATED AT 10ATM FOR 5 SECS. THE PHYSICIAN USED THE STENT'S BALLOON TO POST-DILATE THE CONNECTING PART OF THESE 2 STENTS. THE CYPHER SELECT DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENT DISTRIBUTED IN THE US. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2011-00667 AND 9616099-2011-00668.

Additional Manufacturer Narrative · 1

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 13249515 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THIS IS ONE OF TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2011-00667 AND 9616099-2011-00668.

Additional Manufacturer Narrative · 1

THE INFORMATION RECEIVED INDICATED THAT APPROXIMATELY THREE YEARS AFTER THE INDEX PROCEDURE, THE PATIENT HAD ACUTE MYOCARDIAL INFARCTION (MI). CORONARY ANGIOGRAPHY (CAG) WAS PERFORMED AND REVEALED THAT THE STENT WAS FRACTURED. THE FRACTURED STENT WAS COMPLETELY SEPARATED. NINETEEN DAYS LATER, CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED. THE CABG WAS PERFORMED TO BYPASS THE FRACTURED STENT TREATED. THE PATIENT IS IN STABLE CONDITION. FOR THE INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH CORONARY ARTERY DISEASE (CAD) AND ACUTE CORONARY SYNDROME (ACS). DURING THE INDEX PROCEDURE, THE PATIENT WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) AT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION. THE STENOSIS PERCENTAGE IN THE PROXIMAL-LAD WAS 90% STENOSIS. THE TARGET LESION WAS A COMPLETE OCCLUSION (> 3 MONTHS). TWO STENTS WERE PLACED AT THE PROXIMAL LAD AND DISTAL-LAD LESION. ONE STENT WAS IMPLANTED AT PROXIMAL STENOSIS SEGMENT AND ONE STENT WAS IMPLANTED AT DISTAL STENOSIS SEGMENT. THE STENTS DID NOT OVERLAP; THE TWO STENTS WERE JUST CONNECTED. THE PHYSICIAN USED 6F JL4 ST GUIDING CATHETER TO REACH THE LCA OSTIAL. HE ADVANCED SUPRSOFT GUIDEWIRE TO CROSS THROUGH THE LESION. THEN HE USED 2.5 X 20MM BALLOON (AVITA) TO PRE-DILATE DISTAL LESION AT 14ATM FOR 10 SECS. AFTER THAT, THE PHYSICIAN IMPLANTED 3.0 X 28MM STENT AT DISTAL STENOSIS SEGMENT AND 3.5 X 23MM STENT AT PROXIMAL STENOSIS SEGMENT. THE DEPLOYMENT PRESSURE OF THESE TWO STENTS WAS 18ATM. THESE TWO STENTS WERE CONNECTED TOGETHER. SO THE PHYSICIAN USED STENT'S BALLOON TO POST-DILATE THE CONNECTING PART OF THESE 2 STENTS AT 10ATM FOR 5 SECS. THE STENT WAS POST-DILATED AT 10ATM FOR 5 SECS. THE PHYSICIAN USED THE STENT'S BALLOON TO POST-DILATE THE CONNECTING PART OF THESE 2 STENTS. A CD WITH PROCEDURAL IMAGES WAS RECEIVED AND SENT TO INDEPENDENT CARDIOLOGIST FOR REVIEW. THE FILM REVIEW REPORT IS PENDING. 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. MYOCARDIAL INFARCTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. WHILE NOT OBSERVED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. THERE ARE POSSIBLE PATIENT AND VESSEL/LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NEITHER THE DHR 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 TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2011-00667 AND 9616099-2011-00668.

Additional Manufacturer Narrative · 1

THE INFORMATION RECEIVED INDICATED THAT APPROXIMATELY THREE YEARS AFTER THE INDEX PROCEDURE, THE PATIENT HAD ACUTE MYOCARDIAL INFARCTION (MI). CORONARY ANGIOGRAPHY (CAG) WAS PERFORMED AND REVEALED THAT THE STENT WAS FRACTURED. THE FRACTURED STENT WAS COMPLETELY SEPARATED. NINETEEN DAYS LATER, CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED. THE CABG WAS PERFORMED TO BYPASS THE FRACTURED STENT TREATED. THE PATIENT IS IN STABLE CONDITION. FOR THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH CORONARY ARTERY DISEASE (CAD) AND ACUTE CORONARY SYNDROME (ACS). DURING THE INDEX PROCEDURE, THE PATIENT WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) AT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION. THE STENOSIS PERCENTAGE IN THE PROXIMAL-LAD WAS 90% STENOSIS. THE TARGET LESION WAS A COMPLETE OCCLUSION (> 3 MONTHS). TWO STENTS WERE PLACED AT THE PROXIMAL LAD AND DISTAL-LAD LESION. ONE STENT WAS IMPLANTED AT PROXIMAL STENOSIS SEGMENT AND ONE STENT WAS IMPLANTED AT DISTAL STENOSIS SEGMENT. THE STENTS DID NOT OVERLAP. THE PHYSICIAN USED 6F JL4 ST GUIDING CATHETER TO REACH THE LCA OSTIAL. HE ADVANCED SUPERSOFT GUIDEWIRE TO CROSS THROUGH THE LESION. THEN HE USED 2.5 X 20MM BALLOON (AVITA) TO PRE-DILATE DISTAL LESION AT 14ATM FOR 10 SECS. AFTER THAT, THE PHYSICIAN IMPLANTED 3.0 X 28MM STENT AT DISTAL STENOSIS SEGMENT AND 3.5 X 23MM STENT AT PROXIMAL STENOSIS SEGMENT. THE DEPLOYMENT PRESSURE OF THESE TWO STENTS WAS 18ATM. THE RATED BURST PRESSURE INDICATED IN THE IFU IS 16 ATMOSPHERES. SO THE PHYSICIAN USED STENT'S BALLOON TO POST-DILATE THE SEGMENT BETWEEN THESE 2 STENTS AT 10ATM FOR 5 SECS. THE STENT WAS POST-DILATED AT 10ATM FOR 5 SECS. A CD WITH PROCEDURAL IMAGES WAS RECEIVED AND SENT TO AN INDEPENDENT CARDIOLOGIST FOR REVIEW. THE FILM REVIEW REPORT INDICATES THE FOLLOWING: THE CINE ANGIOGRAM REVEALED A PATIENT WHO HAD A COMPLETE OCCLUSION IN-STENT OF THE PROXIMAL TO MID-SEGMENT OF THE LAD. IT WAS NOTED THAT THERE WERE TWO STENTS; ONE IN THE PROXIMAL LAD AND THE SECOND IN THE MID LAD. THE SECOND OF WHICH WAS A 3.0X28MM STENT WHICH APPEARED TO BE FRACTURED IN ITS MID TO DISTAL SEGMENT WITH THE DISTAL ONE-THIRD OF THE FRACTURED SEGMENT SEPARATED FROM THE MORE PROXIMAL SEGMENT. THE VESSEL WAS COMPLETELY OCCLUDED JUST PROXIMAL TO THIS. THE PATIENT UNDERWENT SUCCESSFUL REPEAT INTERVENTION AND RE-STENTING. THE ANGIOGRAPHIC RESULT WAS ACCEPTABLE AT THE END. REVIEWING THE ANGIOGRAMS, IT WAS CLEAR THAT THE DISTAL STENT WAS PLACED IN A TORTUOUS SEGMENT. THERE WAS NOT HEAVY CALCIFICATION AND THE MOBILITY OF THE VESSEL DID APPEAR MODERATE BUT NOT SIGNIFICANTLY INCREASED. IN SUMMARY, THERE APPEARED TO BE A STENT FRACTURE LEADING TO THE COMPLETE OCCLUSION OF THIS VESSEL. THE TOTAL OCCLUSION OCCURRED IN THE STENT JUST PROXIMAL TO THE SEPARATION POINT OF THE TWO STENT FRAGMENTS. THERE WAS AT LEAST 3 MM OF SEPARATION OF THE STENTED FRAGMENTS WHICH WAS JUXTAPOSITIONED TO LOCATION OF COMPLETE OCCLUSION. 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. RESTENOSIS AND MYOCARDIAL INFARCTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. WHILE NOT OBSERVED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. STENT FRACTURES CAN LEAD TO VESSEL OCCLUSION. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. THERE ARE POSSIBLE PATIENT AND VESSEL/LESION CHARACTERISTICS(VESSEL TORTUOSITY) AND PROCEDURAL FACTORS (INFLATION OVER RATED BURST PRESSURE) THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NEITHER THE DHR 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 TWO PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2011-00667 AND 9616099-2011-00668.

Description of Event or Problem · 1

THE INFORMATION RECEIVED INDICATED THAT APPROXIMATELY THREE YEARS AFTER THE INDEX PROCEDURE, THE PATIENT HAD ACUTE MYOCARDIAL INFARCTION (MI). CORONARY ANGIOGRAPHY (CAG) WAS PERFORMED AND REVEALED THAT THE STENT WAS FRACTURED. THE FRACTURED STENT WAS COMPLETELY SEPARATED. NINETEEN DAYS LATER, CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED. THE CABG WAS PERFORMED TO BYPASS THE FRACTURED STENT TREATED. THE PATIENT IS IN STABLE CONDITION. FOR THE INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH CORONARY ARTERY DISEASE (CAD) AND ACUTE CORONARY SYNDROME (ACS). DURING THE INDEX PROCEDURE, THE PATIENT WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) AT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION. THE STENOSIS PERCENTAGE IN THE PROXIMAL-LAD WAS 90% STENOSIS. THE TARGET LESION WAS A COMPLETE OCCLUSION (> 3 MONTHS). TWO STENTS WERE PLACED AT THE PROXIMAL LAD AND DISTAL-LAD LESION. ONE STENT WAS IMPLANTED AT PROXIMAL STENOSIS SEGMENT AND ONE STENT WAS IMPLANTED AT DISTAL STENOSIS SEGMENT. THE STENTS DID NOT OVERLAP; THE TWO STENTS WERE JUST CONNECTED. THE PHYSICIAN USED 6F JL4 ST GUIDING CATHETER TO REACH THE LCA OSTIAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CYPHER SIROLIMUS-ELUTING CORONARY STENT	DRUG-ELUTING STENT (NIQ)	NIQ	CORDIS DE MEXICO	NA	13249515

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Hospitalization\| L\| R