CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 9616099-2010-00747
Event Type: Injury
Date Received: October 5, 2010
Date of Event: August 16, 2006
Report Date: September 10, 2010
Manufacturer: CORDIS DE MEXICO
Product Code: NIQ
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT CONCLUSION: A (B)(6) MALE FROM THE (B)(4) STUDY EXPERIENCED A MYOCARDIAL INFARCTION DUE TO THROMBUS APPROXIMATELY TWO WEEKS AFTER IMPLANTATION OF TWO CYPHER STENTS. THE PATIENT DECEASED DUE TO HEART FAILURE A MONTH AND HALF LATER. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED HIS RISK FOR MACE INCLUDED HYPERTENSION, AND PAST HISTORY OF PCI. THE INDICATION FOR THE INDEX PROCEDURE WAS AN ACUTE MYOCARDIAL INFARCTION (AMI). THE IFU CONTRAINDICATES THIS PRODUCT IN PATIENTS WHO HAD SUFFERED FROM AMI WITHIN 72 HOURS. THIS PATIENT'S EMERGENT PRESENTATION WITH AN AMI PUTS HIM AT INCREASED RISK FOR MACE. IN ADDITION, HIS PRESENTATION WITH AN AMI PUTS HIM IN A HYPERCOAGULABLE STATE AND AT INCREASED RISK FOR THROMBOTIC EVENTS. A LESION IN THE MID LAD WAS TREATED. THE LESION WAS A DE-NOVO, BUT OTHER LESION INFORMATION WAS UNKNOWN. AHA/ACC CLASSIFICATION OF THE VESSEL WAS C. THE LESION LENGTH WAS APPROXIMATELY 50MM AND THE VESSEL DIAMETER WAS APPROXIMATELY 2.5-3.0MM. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. THE ACC DEFINES A TYPE C LESION AS A HIGH-RISK LESION WITH LESS THAN 60% SUCCESS RATE OF TREATMENT. IT IS UNKNOWN IF PRE-DILATION WAS CONDUCTED. THE 1ST CYPHER BX (2.5/23MM) WAS IMPLANTED AT 16ATM (INFLATION TIME UNKNOWN) AT THE DISTAL PORTION OF THE TARGET LESION. THEN, THE 2ND CYPHER BX (3.0/33MM) WAS IMPLANTED AT 14ATM (INFLATION TIME UNKNOWN) PROXIMAL TO THE 1ST CYPHER BX, OVERLAPPING IT. IT IS UNKNOWN IF POST-DILATION WAS CONDUCTED. THE RESIDUAL % OF STENOSIS WAS UNKNOWN. TIMI FLOW BEFORE AND AFTER THE PROCEDURE WAS UNKNOWN. IVUS WAS NOT CONDUCTED. IT IS UNKNOWN IF ACT WAS MEASURED. MEDICATIONS PRESCRIBED AFTER THE PROCEDURE INCLUDED ASPIRIN AND TICLOPIDINE. TWELVE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED ST-ELEVATED MYOCARDIAL INFARCTION. A CORONARY ANGIOGRAPHY REVEALED THROMBUS INSIDE THE 1ST AND 2ND CYPHER BX IMPLANTED IN THE MID LAD. TO TREAT THE THROMBUS, POBA WAS CONDUCTED. APPROXIMATELY A MONTH AND A HALF LATER, THE PATIENT'S CONDITION DID NOT IMPROVED DESPITE TREATMENT AND THE PATIENT DIED DUE TO HEART FAILURE. 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. THROMBOSIS, MYOCARDIAL INFARCTION AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR THROMBOTIC EVENTS INCLUDE THOSE WITH LONG LESIONS, A VESSEL DIAMETER LESS THAN 3MM AND PREVIOUS THROMBUS. DISCONTINUATION OF ANTIPLATELET THERAPY MAY CAUSE THROMBUS FORMATION. THE PHYSICIAN COMMENTED THAT "THE CAUSE OF THE DEATH WAS HEART FAILURE. THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT THE IMPLANTED STENTS MIGHT HAVE BEEN UNDER-DILATED." REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE POSSIBLE PATIENT, LESION CHARACTERISTICS AND PROCEDURAL FACTORS 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. (B)(4) CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00747 AND 9616099-2010-00749.

Additional Manufacturer Narrative · 1

ASPIRIN 200MG/DAY: 2000-(B)(6) ~ 2006-(B)(6).TICLOPIDINE HYDROCHLORIDE 200MG/DAY: 2000-(B)(6) ~ 2006-(B)(6).HEPARIN UNKNOWN DOSAGE: 2006-(B)(6) (DURING THE PCI).(B)(4).ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00747 AND 9616099-2010-00749.

Description of Event or Problem · 1

AS REPORTED VIA THE (B)(6) STUDY, A PATIENT EXPERIENCED STENT THROMBOSIS, A MYOCARDIAL INFARCTION (MI), AND POSSIBLE UNDER INFLATED STENT. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED A 50MM TYPE C LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS A DE-NOVO AND THE VESSEL DIAMETER WAS 2.5 TO 3.0MM. THE INDICATION FOR THE PROCEDURE WAS AN ACUTE MI. IT IS UNKNOWN IF PRE-DILATION WAS CONDUCTED. A 2.5 X 23MM CYPHER BX WAS IMPLANTED AT 16ATM AT THE DISTAL PORTION OF THE TARGET LESION AND A 3.0 X 33MM CYPHER BX WAS IMPLANTED AT 14ATM PROXIMAL TO THE FIRST CYPHER BX, OVERLAPPING IT. IT IS UNKNOWN IF POST-DILATION WAS CONDUCTED. THE RESIDUAL PERCENTAGE OF STENOSIS WAS UNKNOWN. IVUS WAS NOT CONDUCTED, AND IT IS UNKNOWN IF ACT WAS MEASURED. APPROXIMATELY TWELVE DAYS LATER, THE PATIENT DEVELOPED AN ST-ELEVATED MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED THROMBUS INSIDE BOTH CYPHER BX STENTS. THE THROMBUS WAS TREATED WITH BALLOON ANGIOPLASTY. THE PATIENT'S CONDITION DID NOT IMPROVE, AND THEY EXPIRED DUE TO HEART FAILURE APPROXIMATELY SIX WEEKS LATER. ACCORDING TO THE PHYSICIAN, THE CAUSE OF DEATH WAS HEART FAILURE AND THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT THE IMPLANTED STENTS MIGHT HAVE BEEN UNDER-DILATED.

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		I0606005

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Hospitalization\| L\| R