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

Model Number 9554

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

Patient Problems Cardiac Arrest (1762); Death (1802); ST Segment Elevation (2059); Thrombosis (2100); Cardiogenic Shock (2262)

Event Date 12/19/2020

Event Type  Death  

Event Description

It was reported that the patient died.The 70% stenosed, de novo target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.After the lesion was pre-dilated with 2.50mm x 15mm maverick balloon catheter, a 38 x 3.50 promus premier drug-eluting stent was implanted.Following stent deployment, a 12mm x 4.00mm nc quantum apex balloon catheter was advanced for post dilatation and the procedure was completed.However, several hours after the procedure, the patient developed cardiogenic shock with st elevation in avr, v1, v2, and v3.The following day, the patient experienced cardiac arrest and was connected to ventilator support.Despite of cardiopulmonary resuscitation and emergency medication, the patient died on december 16th.The physician believed that there might have acute thrombosis inside the implanted stent that resulted to the patient's death.

Event Description

It was reported that the patient died.The 70% stenosed, de novo target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.After the lesion was pre-dilated with 2.50mm x 15mm maverick balloon catheter, a 38 x 3.50 promus premier drug-eluting stent was implanted.Following stent deployment, a 12mm x 4.00mm nc quantum apex balloon catheter was advanced for post dilatation and the procedure was completed.However, several hours after the procedure, the patient developed cardiogenic shock with st elevation in avr, v1, v2, and v3.The following day, the patient experienced cardiac arrest and was connected to ventilator support.Despite cardiopulmonary resuscitation and emergency medication, the patient died on (b)(6) 2020.The physician believed that there might have been acute thrombosis inside the implanted stent that resulted to the patient's death.However, it was further reported that balloon was fully deployed and was deflated for 10 seconds prior to pulling it back.Optimal flow was restored at the lesion site timi-1.Follow-up angiography could not be performed to confirm the presence of thrombus within the deployed stent.

Manufacturer Narrative

B5: describe event or problem - updated with additional information received.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11131616
• MDR Text Key: 225520263
• Report Number: 2134265-2020-18553
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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: 06/02/2022
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0025567607
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death