CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 9616099-2011-00722
Event Type: Malfunction
Date Received: September 12, 2011
Date of Event: August 1, 2011
Report Date: August 9, 2011
Manufacturer: CORDIS DE MEXICO
Product Code: NIQ
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE ORIGINAL REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE STENT (CYPHER SELECT + 3.50X18 MM) COULD NOT PASS THROUGH THE LESION. THE PHYSICIAN CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. WHEN THE PRODUCT WAS RECEIVED FOR EVALUATION IT WAS NOTICED TO BE SEPARATED IN TWO AT 75 CM FROM THE DISTAL END. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS A (B)(6) MALE. THE TARGET LESION WAS THE LEFT MAIN (LM). THE VESSEL WAS DESCRIBED AS SEVERELY CALCIFIED WITH AN 85% STENOSIS. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. IT WAS NOTED THAT THERE WAS SOME DIFFICULTY ACCESSING THE LESION WITH THE TERUMO GUIDEWIRE. THE LESION WAS PRE-DILATED WITH A TERUMO BALLOON AT 10 ATM. THE CYPHER STENT DELIVERY SYSTEM WAS ADVANCED OVER THE GUIDEWIRE BUT THE STENT COULD NOT CROSS THROUGH THE LESION. IT WAS NOTED THAT THE PHYSICIAN, AT THIS POINT, USED EXCESSIVE FORCE AND INADVERTENTLY BROKEN THE SHAFT. THE PRODUCT WAS SEPARATED IN THE TERUMO GUIDING CATHETER, SO THE GUIDING CATHETER AND THE SDS WERE REMOVED AS A UNIT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE SDS THERE WAS SOME RESISTANCE FELT, BUT WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT. THERE WAS NO PATIENT INJURY REPORTED. ONE NON STERILE CYPHER SELECT + 3.50X18 MM WAS RECEIVED COILED INSIDE A PLASTIC BAG. IT WAS SEPARATED (BROKEN) IN TWO AT 75 CM FROM DISTAL END IN THE METAL SHAFT AREA. THE STENT WAS MOUNTED IN ITS ORIGINAL POSITION BETWEEN MARKER BANDS; IT WAS CRIMPED AND DID NOT SHOW ANY DAMAGE. THE SECTION WHERE THE SHAFT GOT SEPARATED (BROKEN) APPEARS AS IF IT HAD BEEN BENT BEFORE IT GOT BROKEN. CROSSING PROFILE OF THE STENT WAS FOUND WITHIN SPECIFICATION. IN THE FUNCTIONAL ANALYSIS, THE SDS PASSED AND WAS WITHDRAWAL THROUGH A LAB SAMPLE GUIDING CATHETER FR 5 WITHOUT ANY RESISTANCE. THE SECTION WHERE THE SHAFT GOT SEPARATED (BROKEN) APPEARS AS IF IT HAD BEEN BENT BEFORE IT GOT BROKEN. 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. THE FAILURE REPORTED BY THE CUSTOMER "BODY SHAFT SEPARATED-IN PATIENT" WAS CONFIRMED. THE FAILURE TO CROSS REPORTED COULD NOT BE CONFIRMED SINCE THE CROSSING PROFILE OF THE STENT WAS FOUND WITHIN SPECIFICATION. THE WITHDRAWAL DIFFICULTY-THROUGH GUIDE/SHEATH COULD NOT BE CONFIRMED. THE CAUSE OF THE FAILURES REPORTED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. DURING MANUFACTURING PROCESS THERE IS A CONTROL TO DETECT DAMAGES IN THE BODY BEFORE THE UNITS LEAVE THE FACILITY. SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE SDS PRE-STENT IMPLANTATION, THE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW STENT/SDS REMOVAL INSTRUCTIONS AND/OR APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR SDS COMPONENTS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE POSSIBLE VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS (FORCE USED) THAT COULD HAVE CONTRIBUTED TO THE EVENTS. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSES SUGGEST THAT THE REPORTED FAILURES COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN.

Additional Manufacturer Narrative · 1

THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS A (B)(6) MALE. THE TARGET LESION WAS THE LEFT MAIN (LM). THE VESSEL WAS DESCRIBED AS SEVERELY CALCIFIED WITH AN 85% STENOSIS. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. IT WAS NOTED THAT THERE WAS SOME DIFFICULTY ACCESSING THE LESION WITH THE TERUMO GUIDEWIRE. THE LESION WAS PRE-DILATED WITH A TERUMO BALLOON AT 10 ATM. THE CYPHER STENT DELIVERY SYSTEM WAS ADVANCED OVER THE GUIDEWIRE BUT THE STENT COULD NOT CROSS THROUGH THE LESION. IT WAS NOTED THAT THE PHYSICIAN, AT THIS POINT, USED EXCESSIVE FORCE, USED EXCESSIVE FORCE AND INADVERTENTLY BROKEN THE SHAFT. THE PRODUCT WAS SEPARATED IN THE TERUMO GUIDING CATHETER, SO THE GC AND THE SDS WERE REMOVED AS A UNIT. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE SDS THERE WAS SOME RESISTANCE FELT, BUT WAS SUCCESSFULLY REMOVED. THE PHYSICIAN SUCCESSFULLY IMPLANTED THE OTHER COMPANY'S STENT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY CAUSED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem · 1

THE ORIGINAL REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE STENT (CYPHER SELECT + 3.50X18MM) COULD NOT PASS THROUGH THE LESION. THE PHYSICIAN CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. WHEN THE PRODUCT WAS RECEIVED FOR EVALUATION IT WAS NOTICED TO BE SEPARATED IN TWO AT 75CM FROM THE DISTAL END. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE STATES THAT DURING THE PROCEDURE, THE STENT COULD NOT CROSS THROUGH THE LESION, SO THE PHYSICIAN USED EXCESSIVE FORCE AND INADVERTENTLY BROKE THE SHAFT. THE PRODUCT SEPARATED IN THE GUIDING CATHETER (NON CORDIS GUIDING CATHETER), NOT IN THE PATIENT'S VESSEL. THEREFORE, THE PHYSICIAN WITHDREW THE GUIDING CATHETER AND THE STENT TOGETHER AND CHANGED ANOTHER CYPHER STENT DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. NO PATIENT INJURY CAUSED.

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	15333405

Patients

Seq	Age	Sex	Outcome	Treatment
1