CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 9616099-2008-01365
Event Type: Injury
Date Received: May 21, 2008
Date of Event: March 30, 2008
Report Date: April 25, 2008
Manufacturer: CORDIS DE MEXICO
Product Code: NIQ
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT # 9616099-2008-01364.

Description of Event or Problem · 1

THIS MALE PATIENT WITH A HISTORY OF HYPERLIPIDEMIA, SMOKING, DIABETES (INSULIN DEPENDANT), AND PREVIOUS MI WAS ADMITTED FOR CORONARY EVALUATION DUE TO AN ACUTE, ST-ELEVATION, INFERIOR WALL, Q-WAVE MI LESS THAN 5 HOURS FROM ONSET OF SYMPTOMS. THE PATIENT WAS NOT CURRENTLY TAKING ANY CARDIAC MEDICATIONS. UPON ARRIVAL, THROMBOLYTIC AGENTS, ASPIRIN, AND HEPARIN WERE ADMINISTERED. CLOTTING TIMES WERE NOT MEASURED. ADDITIONALLY, THE PATIENT REQUIRED TEMPORARY PACEMAKER SUPPORT. PRE-PROCEDURE THE PATIENT'S HEART RATE WAS 79 (SINUS0, BP WAS 92/57 MMHG, PLATELETS WERE 180,000 G/UL, AND HGB WAS 12.2 G/DL. CARDIAC ENZYMES MEASURED PRE-PROCEDURE REVEALED CK>5 TIMES ULN, CK-MB=4 TIMES ULN, AND TROPONIN > 5 TIMES ULN. ANGIOGRAPHY REVEALED A 100% (CTO), 50MM, DE NOVO, SMOOTH, CONCENTRIC, B2 TYPE LESION IN THE DISTAL RCA. THE VESSEL WAS DESCRIBED AS 2.5MM IN DIAMETER, WITH TIMI 1 FLOW. THERE WAS THROMBUS PRESENT IN THE LESION SITE. THE THROMBUS WAS ASPIRATED PRIOR TO TREATMENT. THE LESION WAS PREDILATED WITH A 3.0 X 20MM BALLOON INFLATED TO 10 ATMS. TWO CYPHER SELECT PLUS STENTS, A 3.0 X 33MM AND A 3.0 X 13MM, WERE POSITIONED WITHIN THE TARGET AND WERE DEPLOYED TO 14 ATMS AND 18 ATMS, RESPECTIVELY. THE STENTS DID NOT OVERLAP (ABUTTING). THE FINAL RESULT WAS SATISFACTORY WITH 0% RESIDUAL STENOSIS AND TIMI III FLOW THROUGH THE VESSEL. NO PROCEDURAL COMPLICATIONS WERE REPORTED. A STAGED PROCEDURE WAS PLANNED (DUE TO CARDIAC SAFETY) TO TREAT AN ADDITIONAL LESION IN THE FIRST OBTUSE MARGINAL BRANCH (OM1). THE PATIENT WAS RELEASED FROM THE CATH LAB ON A HEPARIN DRIP, PLAVIX AND ASPIRIN. CARDIAC ENZYMES REPORTED POST PROCEDURE REMAINED ELEVATED, BUT WERE TRENDING DOWNWARD, AS EXPECTED. AT 6-24 HOURS POST, CK=2 TIMES ULN, CK-MB=2 TIMES ULN AND TROPONIN > 5 TIMES ULN. AT MORE THAN 24 HOURS, CK=2 TIMES ULN, CK-MB<2 TIMES ULN, AND TROPONIN >5 TIMES ULN. THE FOLLOWING DAY, THE PATIENT COMPLAINED OF CHEST PAIN. THERE WERE NO ECG CHANGES. REPEAT ANGIOGRAPHY REVEALED A 50%, NON-OCCLUSIVE THROMBOTIC OCCLUSION AT THE EXIT OF THE CYPHER STENT IN THE DISTAL RCA. THE PHYSICIAN FELT THAT THIS WAS RESIDUAL THROMBUS FROM THE THROMBUS THAT WAS PRESENT PRE-PROCEDURE. THE SITE WAS TREATED WITH ADDITIONAL BALLOON INFLATIONS (BALLOON ANGIOPLASTY) AND THE EVENT RESOLVED WITHOUT SEQUELAE. THE FOLLOWING DAY, THE PATIENT RETURNED TO THE CATH LAB TO COMPLETE THE PLANNED STAGED PROCEDURE TO TREAT AN 80% LESION IN THE OM1. THE DATABASE INFO INDICATES THAT THERE WAS ALSO AN 80% "RESTENOSIS" IN THE CYPHER STENT IN THE DISTAL RCA; HOWEVER, IT THEN INDICATES THAT THERE WAS NO IN-STENT RESTENOSIS, OR PERI-STENT RESTENOSIS. ATTEMPTS TO CLARIFY THIS ARE ONGOING. THE RCA WAS NOT TREATED. THE LESION IN THE OM1 WAS SUCCESSFULLY TREATED (DETAILS UNKNOWN). THERE WAS 0% RESIDUAL STENOSIS FOLLOWING TREATMENT. THERE WERE NO REPORTED COMPLICATIONS. THE PT WAS DISCHARGED IN STABLE CONDITION AFTER A TOTAL OF FIVE DAYS HOSPITALIZATION WITH ORDERS FOR DAILY ADMINISTRATION OF INSULIN, ASPIRIN, PLAVIX, STATINS, ACE INHIBITORS, AND BETA-BLOCKERS.

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	13339443

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Hospitalization\| L\| R	THROMBOLYTICS\| HEPARIN\| PLAVIX\| ASPIRIN