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Adverse Event Report

CORDIS CORP CORDIS CYPHER, DRUG ELUTING STENT   back to search results
Model Number CWS18250
Device Problem Blockage
Event Date 12/10/2003
Patient Outcome  Life Threatening; Required Intervention
Event Description

Pt discharged in 2003 after having stents placed to lad and circumflex the previous day. Presented with chest pain radiating into neck the next day. Taken to cath lab and lad occluded proximal to the stent. A 3. 5 x 8 cypher stent placed in proximal lad.

 
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Brand NameCORDIS
Type of DeviceCYPHER, DRUG ELUTING STENT
Baseline Brand NameCYPHER SIROLIMUS-ELUTING CORONARY STENT
Baseline Generic NameDRUG ELUTING STENT
Baseline Catalogue NumberCWS18250
Baseline Device FamilyCORONARY SDS/STENTS
Baseline Device 510(K) Number
Baseline Device PMA NumberP020026
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)3
Date First Marketed04/24/2003
Manufacturer (Section F)
CORDIS CORP
po box 025700
miami FL 33102
Manufacturer (Section D)
CORDIS CORP
po box 025700
miami FL 33102
Device Event Key499270
MDR Report Key510320
Event Key484125
Report Number510320
Device Sequence Number1
Product CodeNIQ
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/15/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberCWS18250
Device Catalogue NumberCWS18250
Device LOT Number51003019
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/10/2003
Event Location Hospital
Date Report TO Manufacturer12/15/2003
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 02/05/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1 STENT TO CIRCUMFLEX PLACED IN 2003. 01/01/2003

Database last updated on February 28, 2009

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