CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 9616099-2010-00962
Event Type: Malfunction
Date Received: December 16, 2010
Report Date: November 22, 2010
Manufacturer: CORDIS DE MEXICO
Product Code: NIQ
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION RECEIVED (B)(4) 2011 INDICATED THAT ONLY 1 OF THE 2 STENTS WAS FRACTURED. THEREFORE, WE ARE UNREPORTING THE FRACTURE FOR THIS STENT. THIS PRODUCT IS NO LONGER CONSIDERED TO MEET THE CRITERIA OF A REPORTABLE COMPLAINT ACCORDING TO FDA GUIDELINES. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00961.

Additional Manufacturer Narrative · 1

THE EVENT DATE IS UNKNOWN. THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2010-00961. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9. 'SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION' THE LITERATURE IS FROM WAKAYAMA NATIONAL HOSPITAL AND WAKAYAMA MEDICAL UNIVERSITY. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS LAD BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN ISR BUT IT WAS A CTO LESION. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, TWO CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE STENT TOTAL LENGTH WAS 59MM AND THE STENT DIAMETER WAS 3.0MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6~9 MONTHS AFTER THE IMPLANT. THE STENT FRACTURE WAS OBSERVED BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE %DS AT 1ST CAG WAS 35% AND POPMA ET AL CLASSIFICATION WAS II. LATE RESTENOSIS WAS NOTED AT A NONFRACTURE SITE. THE LOCATION OF THE RESTENOSIS IN RELATION TO THE CYPHER STENTS WAS UNKNOWN. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MULTIPLE ATTEMPTS TO DETERMINE WHICH OF THE TWO CYPHER STENTS WAS FRACTURED WERE UNSUCCESSFUL. IT IS OUR INTENTION TO REPORT CONSERVATIVELY WHEN INFORMATION IS NOT AVAILABLE AND THEREFORE BOTH CYPHER STENTS WILL BE REPORTED WITH FRACTURE AND RESTENOSIS. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. STENT DAMAGE/DEFORMATION AND RESTENOSIS/REOCLUSSION ARE KNOWN ADVERSE EVENTS INDICATED IN THE IFU. 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. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE OVERLAPPING STENTS, CARDIAC MOTION AND VESSEL ANGULATIONS/TORTUOSITY FOR THE NATIVE CORONARY ARTERY. BASED ON THE LIMITED PROCEDURAL INFORMATION AND WITHOUT FILMS, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENTS. HOWEVER, VESSEL/LESION CHARACTERISTICS AND PROCEDURAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem · 1

THIS COMPLAINT IS FROM LITERATURE. AMERICAN HEART JOURNAL 2010;160:775.E1-775.E9 "SERIAL ANGIOGRAPHIC FINDINGS AND PROGNOSIS OF STENT FRACTURE SITE WITHOUT EARLY RESTENOSIS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION." THE LITERATURE IS FROM (B)(6) HOSPITAL AND (B)(6) MEDICAL UNIVERSITY. THIS CASE IS 23RD OF 29 EVENTS. THE PATIENT WAS A (B)(6) MALE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE CORONARY ARTERY DISEASE. THE TARGET LESION WAS LAD BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NOT AN ISR BUT IT WAS A CTO LESION. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. BEFORE THE EVENT OCCURRED, TWO CYPHER BX (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE STENT TOTAL LENGTH WAS 59MM AND THE STENT DIAMETER WAS 3.0MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. THE FIRST FOLLOW-UP ANGIOGRAM WAS PERFORMED 6-9MONTHS AFTER THE IMPLANT. THE STENT FRACTURE WAS OBSERVED BUT NO BINARY RESTENOSIS WAS OBSERVED AT THE FRACTURE SITE. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE %DS AT 1ST CAG WAS 35% AND POPMA ET AL CLASSIFICATION WAS II. LATE RESTENOSIS WAS NOTED AT A NONFRACTURE SITE.

Description of Event or Problem · 1

ADDENDUM RECEIVED (B)(6) 2011: ONLY 1 OF THE 2 STENTS WAS FRACTURED.

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	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR		Hospitalization\| R