CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 9616099-2010-00966
Event Type: Injury
Date Received: December 16, 2010
Report Date: November 22, 2010
Manufacturer: CORDIS DE MEXICO
Product Code: NIQ
PMA / PMN Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A REPORT OF STENT FRACTURE AND RESTENOSIS 6-9 MONTHS POST IMPLANTATION OF TWO UNKNOWN CYPHER BX STENTS TO TREAT A LEFT ANTERIOR DESCENDING (LAD) LESION WAS NOTED IN 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,' YASUSHI INO, ET. AL, WAKAYAMA, JAPAN. THE PATIENT WAS AN (B)(6) FEMALE. THE INDICATION FOR THE INDEX PROCEDURE WAS ACUTE CORONARY SYNDROME (ACS). THE TARGET LESION WAS LEFT ANTERIOR DESCENDING ARTERY (LAD) BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS (ISR) NOR CHRONIC TOTAL OCCLUSION (CTO) LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. HOWEVER, IT WAS REPORTED THAT PATIENTS WITH INAPPROPRIATE VESSEL SIZE WERE EXCLUDED. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. AT INDEX PROCEDURE TWO CYPHER BX STENTS (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE STENTED LENGTH WAS 34MM AND THE DIAMETER OF THE STENT WAS 2.5MM. HOWEVER, THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP (6~9MONTHS AFTER THE IMPLANT) ANGIOGRAM, THE STENT FRACTURE AND RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN THE FRACTURE SITE AND THE ANGIOGRAPHIC PATTERN OF RESTENOSIS WAS FOCAL TYPE. THE RATE OF STENOSIS WAS 88% AND POPMA ET AL CLASSIFICATION WAS III (FRACTURED / SEPARATED). TO TREAT THE RESTENOSIS, TAXUS (DETAILS UNKNOWN) WAS IMPLANTED. RECURRENT STENT FRACTURE AND RESTENOSIS WERE NOT OBSERVED. NO FURTHER INFORMATION IS AVAILABLE. THE STENTS REMAINS IMPLANTED AND THE LOT NUMBERS ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS, OVERLAPPING STENTS, AND CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. LONGER AND/OR OVERLAPPING STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. IN ADDITION TO PROGRESSION OF EXISTING DISEASE, THE MECHANISM OF RESTENOSIS AFTER STENT FRACTURE MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. BASED ON THE LIMITED PROCEDURAL INFORMATION IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENT; HOWEVER, PROCEDURAL AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. 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 MFG. REPORT # 9616099-2010-00965 AND 9616099-2010-00966.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION RECEIVED (B)(6) 2011 INDICATED THAT ONLY 1 OF THE 2 STENTS WAS FRACTURED. 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 # 9616099-2010-00965 AND 9616099-2010-00966.

Additional Manufacturer Narrative · 1

AFTER THAT, NO RECURRENT RESTENOSIS WAS OBSERVED. DUAL-ANTIPLATELET THERAPY WAS CONDUCTED BUT THE DETAILS OF MEDICATIONS, DOSE AND DURATION WERE UNKNOWN. 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 MFR REPORT # 9616099-2010-00965 AND 9616099-2010-00966.

Additional Manufacturer Narrative · 1

CC UPDATED WITH ADDITIONAL INFORMATION THAT ONLY ONE OF THE TWO IMPLANTED CYPHERS WAS FRACTURED. A REPORT OF STENT FRACTURE AND RESTENOSIS 6-9 MONTHS POST IMPLANTATION OF TWO UNKNOWN CYPHER BX STENTS TO TREAT A LEFT ANTERIOR DESCENDING (LAD) LESION WAS NOTED IN 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,' YASUSHI INO, ET. AL, WAKAYAMA, JAPAN. ADDITIONAL INFORMATION REPORTED THAT ONLY ONE OF THE TWO STENTS WAS FRACTURED. THE PATIENT WAS AN (B)(6) FEMALE. THE INDICATION FOR THE INDEX PROCEDURE WAS ACUTE CORONARY SYNDROME (ACS). THE TARGET LESION WAS LEFT ANTERIOR DESCENDING ARTERY (LAD) BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS (ISR) NOR CHRONIC TOTAL OCCLUSION (CTO) LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. HOWEVER, IT WAS REPORTED THAT PATIENTS WITH INAPPROPRIATE VESSEL SIZE WERE EXCLUDED. AHA/ACC CLASSIFICATION OF THE VESSEL WAS UNKNOWN. PRE-PROCEDURE STENOSIS WAS UNKNOWN. NO FURTHER INFORMATION AVAILABLE. AT INDEX PROCEDURE TWO CYPHER BX STENTS (SIZE AND LOT UNKNOWN) WERE IMPLANTED. THE STENTED LENGTH WAS 34MM AND THE DIAMETER OF THE STENT WAS 2.5MM. HOWEVER, THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP (6~9 MONTHS AFTER THE IMPLANT) ANGIOGRAM, THE STENT FRACTURE AND RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN; HOWEVER IT WAS REPORTED THAT THERE WAS A FRACTURE IN ONLY ONE OF THE STENTS. THE RESTENOSIS WAS LOCATED IN THE FRACTURE SITE AND THE ANGIOGRAPHIC PATTERN OF RESTENOSIS WAS FOCAL TYPE. THE RATE OF STENOSIS WAS 88% AND POPMA ET AL CLASSIFICATION WAS III (FRACTURED / SEPARATED). TO TREAT THE RESTENOSIS, TAXUS (DETAILS UNKNOWN) WAS IMPLANTED. RECURRENT STENT FRACTURE AND RESTENOSIS WERE NOT OBSERVED. NO FURTHER INFORMATION IS AVAILABLE. THE STENTS REMAINS IMPLANTED AND THE LOT NUMBERS ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. POSSIBLE FACTORS CONTRIBUTING TO STENT FRACTURES ARE LONG LESIONS, OVERLAPPING STENTS, AND CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. LONGER AND/OR OVERLAPPING STENTS OFTEN STRAIGHTEN OUT THE VESSEL AND MAY BE SUBJECTED TO MORE FORCE AND BENDING MOVEMENTS BECAUSE OF THIS STRAIGHTENING ACTION. IN ADDITION TO PROGRESSION OF EXISTING DISEASE, THE MECHANISM OF RESTENOSIS AFTER STENT FRACTURE MAY BE RELATED TO LOSS OF THE MECHANICAL SCAFFOLDING OF THE STENT AS WELL AS TO INTIMAL HYPERPLASIA AT THE SITE OF VESSEL WALL INJURY. BASED ON THE LIMITED PROCEDURAL INFORMATION IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION REGARDING THE REPORTED EVENT; HOWEVER, PROCEDURAL AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. 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 MFG. REPORT # 9616099-2010-00965 AND 9616099-2010-00966.

Description of Event or Problem · 1

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

Description of Event or Problem · 1

THIS EVENT IS FROM LITERATURE ARTICLE. 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." THIS CASE IS 1ST OF 29 EVENTS. THIS LITERATURE IS FROM (B)(6) HOSPITAL AND (B)(6) MEDICAL UNIVERSITY. THE PATIENT WAS A (B)(6) FEMALE. THE INDICATION FOR THE INDEX PROCEDURE WAS ACUTE CORONARY SYNDROME (ACS). THE TARGET LESION WAS LEFT ANTERIOR DESCENDING ARTERY (LAD) BUT THE DETAILS ARE NOT INDICATED. THE LESION WAS NEITHER AN IN-STENT RESTENOSIS (ISR) NOR CHRONIC TOTAL OCCLUSION (CTO) LESION. THE DIAMETER OF THE VESSEL AND THE LESION LENGTH WERE UNKNOWN. 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 LENGTH WAS 34MM AND THE DIAMETER OF THE STENT WAS 2.5MM. HOWEVER, THE DATE OF THE PROCEDURE AND THE DETAILS OF THE STENT IMPLANTATION WERE UNKNOWN. AT THE FIRST FOLLOW-UP (6-9MONTHS AFTER THE IMPLANT) ANGIOGRAM, THE STENT FRACTURE AND RESTENOSIS WERE OBSERVED. THE LOCATION OF THE STENT FRACTURE WAS UNKNOWN. THE RESTENOSIS WAS LOCATED IN FRACTURE SITE AND THE ANGIOGRAPHIC PATTERN OF RESTENOSIS WAS FOCAL TYPE. THE RATE OF STENOSIS WAS 88% AND POPMA ET AL CLASSIFICATION WAS III (FRACTURED / SEPARATED). TO TREAT THE RESTENOSIS, TAXUS (DETAILS UNKNOWN) WAS IMPLANTED.

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	80 YR		Hospitalization\| L\| R