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 Problems Chest Pain (1776); Discomfort (2330); Vascular Dissection (3160)

Event Date 07/31/2023

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The 80% stenosed target lesion was located in the mildly tortuous proximal left anterior descending artery.The lesion was predilated with a 2.50 x 12 mm non-compliant balloon.A 2.75 x 38 mm promus elite was deployed at 12 atm and prior to post-dilation of the stent, a type b, flow limiting dissection was noted.The patient experienced heavy chest pain and discomfort.An additional drug-eluting stent was implanted to cover the dissection.The procedure was completed and the patient fully recovered and was stable.

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).

• 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: 17510104
• MDR Text Key: 320883612
• Report Number: 2124215-2023-43028
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 0029623259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Race: Asian