MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number UNK432

Device Problem Collapse (1099)

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

Event Description

Same case as mdr id: 2134265-2014-03553, 2134265-2014-03552, 2134265-2014-03973, 2134265-2014-03750, 2134265-2014-03748 and 2134265-2014-03749.It was reported that the stent collapsed and a myocardial infarction occurred.In 2007, four taxus express2 stents were implanted in an unspecified lesion.It was noted that the four stents ¿collapsed¿ and the patient experienced a myocardial infarction.The patient received an additional taxus express2 stent, 2.75x12mm taxus liberte stent and a 2.25x16mm taxus liberte atom stent to open the previously placed collapsed stents.However, it was noted that these stents also collapsed in the years following implantation.No additional patient complications were reported and the patient¿s current condition is fine.

Manufacturer Narrative

If implanted, give date: 2007.Device is combination product.(b)(4).Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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).

• Brand Name: TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3895130
• MDR Text Key: 4654025
• Report Number: 2134265-2014-03554
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 51 YR