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

Model Number 10668

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

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

Event Date 05/27/2020

Event Type  Death  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that cardiac arrest and death occurred.The patient presented with chest pain.Vascular access was obtained via the femoral artery.The 80% stenosed, 3.0 x 55 mm, target lesion was located in the non-tortuous and non-calcified left anterior descending (lad), left main coronary (lm) and left circumflex (lcx) arteries.The physician predilated the lad and deployed the 3 x 38 promus premier select drug-eluting stent (des) in the distal portion of the lad.The 3.5 x 20 promus premier select des was deployed in the proximal portion of the lad and lm.The 3.5 x 24 promus premier select des was deployed in the lcx.During the procedure the patient went into sudden cardiac arrest.The patient died in the critical care unit approximately two hours later.The reason for death is unknown by the physician.

• Brand Name: PROMUS PREMIER SELECT
• 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: 10184996
• MDR Text Key: 196112259
• Report Number: 2134265-2020-08149
• 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: 06/23/2020

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: 05/12/2021
• Device Model Number: 10668
• Device Catalogue Number: 10668
• Device Lot Number: 0023801031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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: 57 YR