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

Model Number 9553

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

Patient Problems Cardiac Arrest (1762); Ischemia (1942)

Event Date 12/26/2021

Event Type  Death  

Event Description

It was reported that the patient died.The patient presented with extensive anterior myocardial infarction.The fully occluded de novo target lesion was located in the moderately calcified proximal left anterior descending artery.After pre-dilation with a 10 x 2.00 non-boston scientific balloon, a 32 x 2.75 promus premier drug eluting stent was successfully deployed.Post deployment, slow flow was observed and the patient went into cardiac arrest.Cardiopulmonary resuscitation was performed on the table and the patient was transferred to the cardiac care unit in stable condition.The patient subsequently died that same day.

Event Description

It was reported that the patient died.The patient presented with extensive anterior myocardial infarction.The fully occluded de novo target lesion was located in the moderately calcified proximal left anterior descending artery.After pre-dilation with a 10 x 2.00 non-boston scientific balloon, a 32 x 2.75 promus premier drug eluting stent was successfully deployed.Post deployment, slow flow was observed and the patient went into cardiac arrest.Cardiopulmonary resuscitation was performed on the table and the patient was transferred to the cardiac care unit in stable condition.The patient subsequently died that same day.It was further reported the physician did not consider the device to have caused or contributed to the patient death.No autopsy was performed.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13192706
• MDR Text Key: 283411289
• Report Number: 2134265-2022-00062
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0027577488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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