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

Model Number 9553

Device Problem Difficult to Advance (2920)

Patient Problems Chest Pain (1776); Death (1802)

Event Date 08/27/2020

Event Type  Death  

Event Description

It was reported there was a patient death.The 80-90 % stenosed target lesion was located in the mildly calcified and mildly tortuous left anterior descending artery (lad).The concentrically shaped de novo target lesion was 32 mm long with a vessel diameter of 3.5 mm.Vascular access was obtained from the right femoral artery.A 6f non-bsc guide catheter and non-bsc wire were used to cross the lad lesion.Predilation was performed with a 1.5x12 non-bsc coronary dilatation catheter.Since the guide had poor support, the guide catheter was exchanged and further pre-dilatation was performed with a 2.5 x 12 non-bsc coronary dilatation catheter.Following pre-dilatation, residual stenosis was 40% and the lesion yielded well.The 32 x 3.50 promus premier stent was advanced for use, but there was difficulty due to the long lesion.A guidezilla guide extension catheter was used for support and the promus premier stent was deployed in the lad.There was no damage to the guidezilla guide extension catheter or promus premier stent.Post-dilation was performed.The patient complained about chest pain and final angioplasty was performed.A non-significant lesion in left circumflex artery (lcx) was observed.A plain old balloon angioplasty (poba) in the lcx was performed and the pain was relieved.The patient was shifted to the cardiac care unit (ccu).The result was good with a timi-3 flow.The patient complained of pain again and two hours later patient death occurred.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10483681
• MDR Text Key: 205327391
• Report Number: 2134265-2020-12170
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2020

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: 09/10/2020
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0022679339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2020
• Initial Date FDA Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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
• Treatment: ABBOTT - 1.5 X12 MINI TREK; ABBOTT - 2.5 X 12 TREK; ABBOTT - 3.75X12 NC TREK OTW; ASAHI - SION BLUE CATHETER GUIDEWIRE; CORONARY GUIDE CATHETER EBU 3.5
• Patient Outcome(s): Death
• Patient Age: 65 YR