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

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.

• 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 Key: 6043719
• MDR Text Key: 57963809
• Report Number: 2134265-2016-09270
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P060008
• Number of Events Reported: 1
• 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 Date: 08/22/2007
• Device Model Number: H7493894016300
• Device Catalogue Number: 38940-1630
• Device Lot Number: 8560193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death