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

Model Number 10677

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

Patient Problem Cardiac Arrest (1762)

Event Date 10/27/2023

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a death occurred.The 90% stenosed lesion was located in a moderately tortuous and mildly calcified left circumflex artery (lcx), left anterior descending (lad) and left main (lm).A 38 x 2.75 mm promus elite was deployed in lad from ostia lad to mid lad.After deployment of the stent, the physician checked the flow, and the flow was ok.A 20 x 3.50 mm promus elite deployed from lm ostia to proximal lcx.After deployment of the second stent, the physician noted that the flow was slow.Then, after few times the flow was no flow.A medical treatment was given to the patient, but the flow was not improved.Then, the patient got sudden cardiac arrest on table.All possible treatments and cpr done by the physician; however, patient was not revived, and the patient had died.

• Brand Name: PROMUS ELITE
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18141899
• MDR Text Key: 328188123
• Report Number: 2124215-2023-64353
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10677
• Device Catalogue Number: 10677
• Device Lot Number: 0031025187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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 Race: Asian