MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER?; STENT, CORONARY, DRUG-ELUTING

Model Number UNK758

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Shock (2072)

Event Date 06/19/2015

Event Type  Death  

Event Description

Same case as mdr id 2134265-2015-04696 and 2134265-2015-04684 it was reported that shock and patient death occurred.The target lesion was located in the tortuous and calcified right coronary artery (rca).A 2.25x16mm promus premier¿ stent was implanted in the target lesion however, several dissections were noted.A 2.25x8mm and a 2.25x12mm promus premier¿ stents were deployed to treat the dissection.There was also a promus premier¿ stent implanted in the circumflex artery which remained patent.Later in the evening, the patient was brought back to the cardiac catheterization laboratory and coronary angiography was performed.It was noted that there was a subacute thrombosis of the previously implanted 2.25x16mm promus premier¿ stent.The physician attempted to advance a guide to the lesion however the vessel started to close.Subsequently, cardiopulmonary resuscitation was started.The patient went into shock and later died that evening.

Manufacturer Narrative

Device is combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

• Brand Name: PROMUS PREMIER?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4934422
• MDR Text Key: 6055831
• Report Number: 2134265-2015-04685
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2015

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 Model Number: UNK758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/23/2015
• 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): Death
• Patient Age: 65 YR