CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 9616099-2008-00447
Event Type: Injury
Date Received: February 25, 2008
Date of Event: September 22, 2007
Report Date: January 29, 2008
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

THIS PRODUCT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MFR REPORT NUMBER IS 9616099-2007-02068. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem · 1

THE TARGET LESION WAS THE LEFT ANTERIOR DESCENDING ARTERY (LAD), WITH ABOVE 80% STENOSIS AND NO CALCIFICATION OR TORTUOSITY. THE LESION WAS 40MM IN LENGTH. THE LESION WAS PRE-DILATED WITH A 2.5X15MM BALLOON. THE CYPHER (3.0X33MM) WAS IMPLANTED IN THE MID LAD. FOLLOWING THIS, A SECOND STENT (UNK) WAS PLACED IN THE OSTIUM OF THE DIAGONAL ARTERY TO TREAT A PLAQUE SHIFT. A SECOND CYPHER (3.0X23MM) WAS THEN ADVANCED INTO THE LAD BUT DISLODGED BEFORE IT REACHED THE TARGET LESION. THE PHYSICIAN DEPLOYED THE STENT AT THE POSITION OF DISLODGING, 4-5MM PROXIMAL TO THE FIRST STENT, SO THERE WAS A GAP. THE PHYSICIAN IMPLANTED A THIRD STENT, 3.0X18MM, TO TREAT THE GAP. THE STENT OVERLAPPED 7MM ON BOTH 1ST AND 2ND STENT. THE STENTS ARE STILL IMPLANTED IN THE PT, THE BALLOON WAS DISCARDED AND JUST VIDEO WILL BE RETURNED FOR INVESTIGATION. THE PT IS UNDER OBSERVATION AND CURRENTLY THE PT'S SITUATION IS STABLE.

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	13241881

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention	2.5X15 BALLOON CATHETER\| CLOPIDOGREL\| MEDICATIONS: ASPIRIN\| DEVICES: 7F GUIDING CATHETER