FDA Adverse Event Injury Summary report: N

CYPHER SIROLIMUS-ELUTING CORONARY STENT

MDR report key: 685209 · Received March 7, 2006

Report

Report Number
9616099-2006-11120
Event Type
Injury
Date Received
March 7, 2006
Date of Event
September 23, 2005
Report Date
March 7, 2006
Manufacturer
CORDIS DE MEXICO
Product Code
NIQ
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
UK
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THERE WAS TOTAL OCCLUSION OF TWO STENTS DEPLOYED 21 MONTHS EARLIER. THIS PATIENT PRESENTED TO CATH WITH STABLE ANGINA, CLASS II. PRE-PROCEDURE MEDICATINS INCLUDED ASPIRIN, CLOPIDOGRAL, ACE-INHIBITORS, STATINS AND CARDURA (AFABLOCKER) INTRA PROCEDURE MEDICATIONS INCLUDED GP LLB/IIIA INHIBITORS AND NITRATES. THE FIRST LESION TREATED WAS THE PROXIMAL RIGHT CORONARY ARTERY .A MAVERICK BALLOON (BOSTON) 2.0X20MM AT 16 ATM WAS USED TO PRE-DILATE THE LESION AND AN ANGIOGRAPHIC COMPLICATION TYPE A OR B DIESSECTION, OCCURRD WITH TIMI I FLOW AND ST ELEVATION AND PAIN AFTER PRE-DILATAION. REOPRO WAS ALSO ADMINISTERED AND A SECOND STENT TO TREAT THE DISSECTION. THE FIRST STENT, A 3.0X33MM CYPHER STENT WAS DEPLOYED AT 16 ATMS. DEPLOYED NEXT WAS A 2.25X33MM CYPHER STENT, IN THE POSTEROLATERAL FROM THE RIGHT CORONARY ARTERY AT 18 ATM. A 3.0X13MM GUIDANT POWERSAIL BALLOON WAS USED TO POST DILATE THE RIGHT CORONARY ARTERY AT 22 ATM. RESIDUAL DIAMETER STENOSIS MEASURED LESS THAN 30%. CK AND CK-MB CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS 24 HOURS POST-PROCEDURE. THE PATIENT WAS DISCHARGED TWO DAYS LATER WITHOUT ANGINAL COMPLAINTS OR SILENT ISCHEMIA. APPROXIMATELY TWO MONTHS LATER, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH UNSTABLE ANGINA, CLASSIIB. ST CHANGES OF THE ANTERIOR WALL NOTED ON ECG. A REPEAT ANGIO WAS DONE AND AN INCREASED SEVERITY OF THE LAD WAS DETECTED. AN URGENT RE-PTCA OF THE LAD ON A NON-TARGET LESION WAS SUCCESSFULLY DONE WITH BALLOON AND STENT. EIGHT MONTHS LATER, THE PATIENT HAD PALPITATIONS THAT WERE TREATED WITH MEDICATIONS. THERE ARE SEVERAL ADDITONAL ADVERSE EVENTS SUCH AS, SHORTNESS OF BREATH FIVE MONTHS LATER, ALSO TREATED WITH MEDICATION. LOW SODIUM, ONE MONTH LATER, THAT WAS TREATED WITH STOPPING SPIRNOLACTONE. THERE WERE ALSO TWO EVENTS OF TCA. TWENTY ONE MONTHS AFTER THE INDEX PROCEDURE THE PATIENT WAS HOSPITALIZED FOR A CORONARY ANGIOGRAM DUR TO UNKNOWN SYMPTOMS. THE ANGIOGRAM REVEALED THAT THERE WAS TOTAL OCCLUSION OF THE TWO STENTS INITIALLY PLACED IN THE RCA. THE PATIENT WAS REFERRED FOR RE-PTCA. ONE MONTH LATER, AN ATTEMPT TO BALLOON THE VESSEL WAS UNSUCCESSFUL BECAUSE THE PHYSICIAN WAS NOT ABLE TO ADVANCE WIRE BALLOON BEYOND RCA/PDA BIFURCATION. THE PATIENT WAS DISCHARGED TWO DAYS LATER. TWO MONTHS LATER, ANOTHER ATTEMPT WAS MADE. ONCE AGAIN, THE "LESION CROSSED WITH WIRE BUT COULD NOT ADVANCE BALLOON". THE PATIENT WAS DISCHARGED THE SAME DAY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA I0903056

Patients

Seq Age Sex Outcome Treatment
1 76 YR Hospitalization| L| R