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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK AG BIOTRONIK ORSIRO STENT CORONARY DRUG-ELUTING STENT

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BIOTRONIK AG BIOTRONIK ORSIRO STENT CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 401742
Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2019
Event Type  malfunction  
Event Description
During a coronary intervention, stent was placed in the artery and stent became dislodged and embolized.
 
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Brand NameBIOTRONIK ORSIRO STENT
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BIOTRONIK AG
MDR Report Key9082500
MDR Text Key159186961
Report NumberMW5089869
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 Risk Manager
Type of Report Initial
Report Date 09/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/12/2020
Device Model Number401742
Device Lot Number10186426
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

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