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Adverse Event Report

CORDIS, A JOHNSON AND JOHNSON COMPANY PALMAZ STENT BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM   back to search results
Lot Number 100256
Event Date 02/18/1998
Patient Outcome  Required Intervention;
Event Description

During procedure for endovascular stent placement, attempt at expansion of the balloon was unsuccessful. Radiologist opined that balloon must have inadvertently been ruptured during the passage through the dilator. Attempt to remove stent and balloon through sheath was unsuccessful and the balloon-mounted stent became dislodged from the balloon. Surgeon performed an emergent cut down on left common femoral artery and stent successfully removed.

 
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Brand NamePALMAZ STENT
Type of DeviceBALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM
Baseline Brand NamePALMAZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM
Baseline Generic NameENDOVASCULAR STENT WITH DELIVERY SYSTEM
Baseline Catalogue NumberP3904
Baseline Device FamilyENDOVASCULAR STENT WITH DELIVERY SYSTEM
Baseline Device 510(K) NumberK911581
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)27
Date First Marketed06/04/1991
Manufacturer (Section F)
CORDIS, A JOHNSON AND JOHNSON COMPANY
40 technology dr
warren NJ 07059
Manufacturer (Section D)
JOHNSON AND JOHNSON INTERVENTIONAL SYSTEMS CO.
40 technology dr.
warren NJ 07059
Device Event Key156722
MDR Report Key160938
Event Key151252
Report Number160938
Device Sequence Number1
Product CodeMIR
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 02/23/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device LOT Number100256
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/20/1998
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer02/23/1998
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 04/02/1998 Patient Sequence Number: 1
#TreatmentTreatment Date
1,PINNACLE INTRODUCER SHEALTH WITH DILATOR,

Database last updated on February 28, 2009

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