• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY TAXUS¿ LIBERTÉ¿; CORONARY DRUG-ELUTING STENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - GALWAY TAXUS¿ LIBERTÉ¿; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493894016300
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Myocardial Infarction (1969); Rupture (2208); Cardiogenic Shock (2262)
Event Date 06/26/2006
Event Type  Death  
Manufacturer Narrative
Device is combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
Same case as mdr id: 2134265-2016-09267.It was reported that the patient died.The patient arrived at the hospital due to the state of his health and immediately underwent a percutaneous coronary intervention (pci).A 4.5x24mm taxus express2 drug eluting stent was deployed.Upon implantation of the taxus express2 stent a no-reflow incident occurred and a second 2.5x15mm unspecified stent was implanted.Four days later a new pci procedure was conducted and a 3.0x16mm taxus liberte drug eluting stent was deployed.During this procedure the vessel was ruptured in the medial d2 (diagonal) branch.Later the same day the patient's temperature rose to 39 celsius.The patient was treated with zinacef and paracetamol.Eleven days later the patient suffered a heart attack with cardiogenic shock.Coronary angiography was performed to exclude stent thrombosis, but later the same day the patient died.The cause of death was documented as heart attack with cardiogenic shock and stop of blood circulation due to pea (pulseless electrical activity).Post mortem analysis disclosed some tissue changes in the stented area.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TAXUS¿ LIBERTÉ¿
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6043719
MDR Text Key57963809
Report Number2134265-2016-09270
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P060008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Physician
Type of Report Initial
Report Date 07/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/22/2007
Device Model NumberH7493894016300
Device Catalogue Number38940-1630
Device Lot Number8560193
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/06/2016
Initial Date FDA Received10/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
-
-