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Adverse Event Report

BAXTER HEALTHCARE CORP. BAXTER LIFESPAN EPTFE VASCULAR GRAFT   back to search results
Model Number BV06040
Event Date 01/20/1996
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The pt underwent surgical intervention for the device reportedly due to thrombosis. On 2/01/96, the pt underwent surgical intervention for the device reportedly due to anastomotic obstruction. On 3/8/96, the pt underwent surgical intervention for the device reportedly due to stenosis. The device remains implanted. No further info provided.

 
Manufacturer Narrative

F1: user facility. H6: 86=device not returned.

 
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Brand NameBAXTER LIFESPAN EPTFE VASCULAR GRAFT
Type of DeviceVASCULAR GRAFT
Baseline Brand NameLIFESPAN EPTFE VASCULAR GRAFT
Baseline Generic NameVASCULAR GRAFT
Baseline Catalogue NumberNA
Baseline Model NumberBV06040
Baseline Device FamilyVASCULAR GRAFT - STRAIGHT
Baseline Device 510(K) NumberK933590
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed03/08/1995
Manufacturer (Section F)
BAXTER HEALTHCARE CORP.
17221 red hill avenue
irvine CA 92614
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
17221 red hill avenue
irvine CA 92614
Manufacturer (Section G)
BAXTER HEALTHCARE CORP.
17221 red hill ave.
irvine CA 92614
Manufacturer Contact
allison mezzanatto
one edwards way
irvine , CA 92614-5686
(949) 250 -2562
Device Event Key100267
MDR Report Key101883
Event Key95771
Report Number6000002-1997-00553
Device Sequence Number1
Product CodeDSY
Report Source Manufacturer
Source Type Study,User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/27/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date12/01/1999
Device MODEL NumberBV06040
Device LOT Number4K1562
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age2 yr
Event Location Hospital
Date Report TO Manufacturer05/27/1997
Date Manufacturer Received05/27/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/1994
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/26/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1 ANGIOPLASTY 02/01/1996

Database last updated on February 28, 2009

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