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Adverse Event Report

CORDIS CORPORATION CORDIS CROWN STENT POWERGRIP DELIVERY SYSTEM STENT DELIVERY SYSTEM   back to search results
Catalog Number CS15-040
Device Problem Dislodged
Event Date 09/10/1998
Event Type  Injury  
Event Description

Text: stent embolized.

 
Manufacturer Narrative

Report rec'd from the field indicated that a 76 year old female pt with a very toruous vessel (90 degree) was undergoing a percutaneous transluminal coronary angioplasty/stenting procedure within a slight bend on the proximal "svg". Difficulty was experienced with the stent delivery system during attempts to cross, and the stent dislodged. A microvena snare was utilized to retrieve the stent without any pt injury or complications. A lot history review revealed that no other complaints of this nature have been rec'd for the products from this sterile lot number. Stent retention values measured for this lot during quality control testing were above the acceptable criteria. Please note that the cordis instructions for use state that the stent can dislodge from the balloon for the following reasons" extremely tortuous vessel anatomy, withdrawing the mounted stent back into the guiding catheter. The product will not be returned for evaluation and testing.

 
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Brand NameCORDIS CROWN STENT POWERGRIP DELIVERY SYSTEM
Type of DeviceSTENT DELIVERY SYSTEM
Baseline Brand NameCORDIS CROWN STENT POWERGRIP
Baseline Generic NameSTENT DELIVERY SYSTEM
Baseline Catalogue NumberCS15-040
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CORDIS CORPORATION
14201 n.w. 60th ave.
miami lakes FL 33014
Manufacturer (Section D)
CORDIS CORPORATION
14201 n.w. 60th ave.
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 n.w. 60th ave.
miami lakes FL 33014
Device Event Key185580
MDR Report Key190989
Event Key179525
Report Number1016427-1998-00382
Device Sequence Number1
Product CodeMAF
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/09/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/01/1999
Device Catalogue NumberCS15-040
Device LOT NumberA0498997
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/10/1998
Event Location Hospital
Date Report TO Manufacturer09/10/1998
Date Manufacturer Received09/10/1998
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on January 30, 2009

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