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

Model Number 10665

Device Problem Failure to Advance (2524)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Ventricular Fibrillation (2130)

Event Date 01/18/2023

Event Type  Death  

Event Description

It was reported that the patient died.The 90% stenosed, moderately tortuous and severely calcified target lesion was located in the left anterior descending artery.A 3.00 x 24 promus premier select was advanced in an attempt to cross the "tight" lesion, but prior to deployment the patient developed ventricular tachycardia and ventricular fibrillation followed by cardiac arrest.Despite several resuscitation attempts, the patient could not be revived and expired during treatment.Per physician, the death was unrelated to implantation of the 3.00 x 24 promus premier select.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16455938
• MDR Text Key: 310382577
• Report Number: 2124215-2023-09025
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10665
• Device Catalogue Number: 10665
• Device Lot Number: 0030235344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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: 65 YR
• Patient Sex: Female