CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 9616099-2013-00129
Event Type: Malfunction
Date Received: March 7, 2013
Date of Event: January 1, 2013
Report Date: February 13, 2013
Manufacturer: CORDIS DE MEXICO
Product Code: NIQ
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SUBSEQUENTLY, STENT IMPLANTATION WAS PERFORMED WITH BIOMATRIX FLEX STENT 3.0/24 MM (BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE, (B)(4)) FOLLOWED BY FINAL POSTDILATION WITH QUANTUM MAVERICK NON-COMPLIANT BALLOON 3.0/20 MM (BOSTON SCIENTIFIC CORPORATION, (B)(4)) INFLATED AT 12 ATM. FINAL INJECTION SHOWED OPTIMAL ANGIOGRAPHIC RESULT, ABSENCE OF RESIDUAL THROMBUS INSIDE THE STENT, AND TIMI 3 FLOW. AFTER PCI PATIENT'S CONDITION IMPROVED, WITH CHEST PAIN DISCONTINUANCE AND RESTORATION OF NORMAL HEMODYNAMIC PARAMETERS (ARTERIAL BLOOD PRESSURE 135/86 MM HG, HEART RATE 82 BPM). THE PATIENT WAS DISCHARGED THREE DAYS LATER WITH THE FOLLOWING MEDICAL THERAPY: ASPIRIN 100 MG, PRASUGREL 10 MG, BISOPROLOL 5 MG, ROSUVASTATIN 20 MG, AND ENALAPRIL 20 MG. THE EXACT IMPLANT DATE OF CYPHER STENTS IS UNKNOWN TO DATE. (B)(4); ACUTE CORONARY SYNDROME DUE TO EARLY MULTIPLE AND COMPLETE FRACTURES IN SIROLIMUS-ELUTING STENT: A CASE REPORT AND BRIEF LITERATURE REVIEW; CATHETER AND CARDIOVASCULAR INTERVENTION; 81(1):52-56. CONCOMITANT MEDICATIONS INCLUDED ASA, BISOPROLOL, PLAVIX, ENALAPRIL, HEPARIN, PRASUGREL, AND ROSUVASTATIN. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE ARTICLE, A PATIENT EXPERIENCED A DOUBLE AND CIRCUMFERENTIAL STENT FRACTURE, THROMBOSIS, AND MYOCARDIAL INFARCTION 36 HOURS POST INITIAL CYPHER STENT PLACEMENT. THIS IS A (B)(6) MALE WITH A MEDICAL HISTORY OF HYPERCHOLESTEROLEMIA, HYPERTENSION, AND SMOKING. AT THE TIME OF INITIAL STENT PLACEMENT, TWO OVERLAPPED CYPHER STENTS (SES), 3.0/33 MM AND 2.75/33 MM, WERE IMPLANTED AT PROXIMAL AND MIDDLE SEGMENTS OF RIGHT CORONARY ARTERY, WITH FINAL HIGH PRESSURE POST-DILATION (3.0/20 MM NON-COMPLIANT BALLOON, INFLATION PRESSURE 24 ATMS). THE PATIENT WAS DISCHARGED 33 HR AFTER PCI WITH MEDICAL THERAPY: ACETYLSALICYLIC ACID (ASA) 100 MG, CLOPIDOGREL 75 MG, ENALAPRIL 20 MG, BISOPROLOL 1.25 MG, AND ROSUVASTATIN 10 MG. JUST 2 HR AND 30 MIN AFTER DISCHARGE, THE PATIENT COMPLAINED FOR SEVERE CHEST PAIN AND WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION, TYPICAL CHEST PAIN AT REST, AND HYPOTENSION (ARTERIAL BLOOD PRESSURE WAS 82/44 MM HG AND HEART RATE 88 BPM). CREATINE KINASE (CK) WAS 365 UI/L, CK-MB 78 UI/L, AND HIGH SENSITIVITY T-TROPONIN 234 NG/L. CORONARY ARTERY ANGIOGRAPHY SHOWED A VERY UNUSUAL FINDING: A DOUBLE AND CIRCUMFERENTIAL SF (STENT FRACTURE). CLOSE TO THE OVERLAP, THERE WAS A CLEAR SEPARATION OF THE DISTAL STENT IN THREE SEGMENTS, WITH DISLOCATION OF THE MIDDLE ONE AND MISALIGNMENT OF ALL THREE. CONTRAST INJECTION SHOWED HAZINESS SUGGESTIVE OF THROMBOSIS INTO THE CONTEXT OF THE FRACTURE AND THROMBOLYSIS IN MYOCARDIAL INFARCTION TIMI 2 FLOW. MOREOVER, RCA APPEARED VERY MOBILE WITH LARGE SYSTO-DIASTOLIC VARIATIONS. AS TREATMENT, THE PROCEDURE STARTED WITH ADMINISTRATION OF 7,000 UI OF UNFRACTIONATED HEPARIN (UFH) AND THROMBOASPIRATION THROUGH AN ELIMINATE CATHETER WITH EXTRACTION OF SMALL AMOUNT OF WHITE THROMBUS. SUBSEQUENTLY, STENT IMPLANTATION WAS PERFORMED WITH BIOMATRIX FLEX STENT 3.0/24 MM (BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE, (B)(4)) FOLLOWED BY FINAL POST-DILATION WITH QUANTUM MAVERICK NON-COMPLIANT BALLOON 3.0/20 MM (BOSTON SCIENTIFIC CORPORATION, (B)(4)) INFLATED AT 12 ATM. FINAL INJECTION SHOWED OPTIMAL ANGIOGRAPHIC RESULT, ABSENCE OF RESIDUAL THROMBUS INSIDE THE STENT, AND TIMI 3 FLOW. AFTER PCI THE PATIENT'S CONDITION IMPROVED, WITH RESOLUTION OF CHEST PAIN AND RESTORATION OF NORMAL HEMODYNAMIC PARAMETERS (ARTERIAL BLOOD PRESSURE 135/86 MM HG, HEART RATE 82 BPM). THE PATIENT WAS DISCHARGED THREE DAYS LATER WITH THE FOLLOWING MEDICAL THERAPY: ASPIRIN 100 MG, PRASUGREL 10 MG, BISOPROLOL 5 MG, ROSUVASTATIN 20 MG, AND ENALAPRIL 20 MG. THE CYPHER STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE HAS BEEN NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. STENT FRACTURE WITH SEPARATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CYPHER STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. THERE ARE MULTIPLE FACTORS THAT CAN CONTRIBUTE TO STENT FRACTURE IN THE CORONARY ARTERIES. THE CORONARY ARTERIES ARE VERY DYNAMIC VESSELS THAT UNDERGO BIOMECHANICAL FORCES SUCH AS FLEXION, TORSION, COMPRESSION, AND ELONGATION. STUDIES HAVE ALSO REVEALED THAT STENT FRACTURES OCCUR IN CASES OF MULTIPLE STENTS AND OVERLAP RELATED TO AN ABNORMAL STRESS AREA THAT IS CREATED. IN THIS CASE, VESSEL/LESION CHARACTERISTICS, PROCEDURAL FACTORS AND/OR BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED EVENT. MYOCARDIAL INFARCTION WITH HYPOTENSION 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. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THE PATIENT WAS MAINTAINED ON A DUAL ANTI-PLATELET REGIMEN AS PER THE IFU. REVIEW OF THE LIMITED INFORMATION DOES NOT SUGGEST WHAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 EVENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2013-00128 AND 9616099-2013-00129.

Description of Event or Problem · 1

AS REPORTED IN THE LITERATURE ARTICLE, A PATIENT EXPERIENCED A DOUBLE AND CIRCUMFERENTIAL STENT FRACTURE, THROMBOSIS, AND MYOCARDIAL INFARCTION 36 HOURS POST INITIAL CYPHER STENTS PLACEMENT. THIS IS A (B)(6) MALE WITH A MEDICAL HISTORY OF HYPERCHOLESTEROLEMIA, HYPERTENSION, AND SMOKING. AT THE TIME OF INITIAL STENTS PLACEMENT, TWO OVERLAPPED CYPHER STENTS (SES), 3.0/33 MM AND 2.75/33 MM, WERE IMPLANTED AT PROXIMAL AND MIDDLE SEGMENTS OF RIGHT CORONARY ARTERY, WITH FINAL HIGH PRESSURE POSTDILATION (3.0/20 MM NON-COMPLIANT BALLOON, INFLATION PRESSURE 24 ATM). THE PATIENT WAS DISCHARGED 33 HR AFTER PCI WITH MEDICAL THERAPY: ACETYLSALICYLIC ACID (ASA) 100 MG, CLOPIDOGREL 75 MG, ENALAPRIL 20 MG, BISOPROLOL 1.25 MG, AND ROSUVASTATIN 10 MG. JUST 2 HR AND 30 MIN AFTER DISCHARGE, THE PATIENT COMPLAINED FOR SEVERE CHEST PAIN AND WAS ADMITTED FOR ACUTE MYOCARDIAL INFARCTION, TYPICAL CHEST PAIN AT REST, AND HYPOTENSION (ARTERIAL BLOOD PRESSURE WAS 82/44 MM HG AND HEART RATE 88 BPM). CREATINE KINASE (CK) WAS 365 UI/L, CK-MB 78 UI/L, AND HIGH SENSITIVITY T-TROPONIN 234 NG/L. CORONARY ARTERY ANGIOGRAPHY SHOWED A VERY UNUSUAL FINDING: A DOUBLE AND CIRCUMFERENTIAL SF. CLOSE TO THE OVERLAP, THERE WAS A CLEAR SEPARATION OF THE DISTAL STENT IN THREE SEGMENTS, WITH DISLOCATION OF THE MIDDLE ONE AND MISALIGNMENT OF ALL THREE. CONTRAST INJECTION SHOWED HAZINESS SUGGESTIVE OF THROMBOSIS INTO THE CONTEXT OF THE FRACTURE AND THROMBOLYSIS IN MYOCARDIAL INFARCTION TIMI 2 FLOW. MOREOVER, RCA APPEARED VERY MOBILE WITH LARGE SYSTO-DIASTOLIC VARIATIONS. AS TREATMENT, THE PROCEDURE STARTED WITH ADMINISTRATION OF 7,000 UI OF UNFRACTIONATED HEPARIN (UFH) AND THROMBOASPIRATION THROUGH ELIMINATE CATHETER WITH EXTRACTION OF SMALL AMOUNT OF WHITE THROMBUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
98033	CYPHER SIROLIMUS-ELUTING CORONARY STENT	DRUG-ELUTING STENT (NIQ)	NIQ	CORDIS DE MEXICO	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Hospitalization\| R