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

Model Number 9551

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 04/12/2020

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

Promus premier (b)(6) registry.It was reported that heart failure occurred and the patient died.In (b)(6) 2019, the subject was referred for cardiac catheterization and index procedure was performed on the same day.The target lesion was located in the proximal right coronary artery (rca) with 100% stenosis and was 22mm long and a reference vessel diameter of 4.0mm.The target lesion was treated with pre-dilatation and placement of a 4.0mmx24mm promus premier drug-eluting stent.Following this post dilation, residual stenosis was 0%.Seven days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with cardiac failure and was hospitalized on the same day for further evaluation and treatment.Three days later, the subject died.The event was treated medically and the primary cause of death was cardiac failure.It was unknown whether the autopsy was performed.No additional information would be available for the event.

• 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: 11510249
• MDR Text Key: 240552842
• Report Number: 2134265-2021-02570
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2021

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: 07/24/2020
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0022451790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 84 YR