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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK, INC. BIOTRONIK CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT

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BIOTRONIK, INC. BIOTRONIK CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number OSIRO 3.0/22
Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/03/2019
Event Type  Injury  
Event Description
Pt is a (b)(6) male with a history of cardiovascular disease. On (b)(6) 2019, the pt was undergoing a cardiac catheterization with stenting in the cardiac cath lab. Following an attempt to deploy a stent it was discovered that the stent could not be found in the balloon apparatus. The undeployed stent was located by fluoroscopy in the left common femoral artery territory. The md disclosed the event to the pt and a decision was made to leave the stent alone as long as the pt remains asymptomatic. The pt is currently in stable condition. Fda safety report id# (b)(4).
 
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Brand NameBIOTRONIK CORONARY STENT SYSTEM
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK, INC.
lake oswego OR 97035
MDR Report Key9451734
MDR Text Key170641134
Report NumberMW5091584
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOSIRO 3.0/22
Device Lot Number06191067
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/10/2019 Patient Sequence Number: 1
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