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); Non specific EKG/ECG Changes (1817); Vascular Dissection (3160)

Event Date 02/18/2024

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The 80% stenosed target lesion was located in the moderately tortuous left anterior descending artery.The lesion was pre-dilated with a 2.75 x 12 mm non-compliant balloon.A 3.00 x 38 mm promus elite was deployed at 11 atm and post-dilated with a 3.00 x 12 mm non-compliant balloon at 14 atm.A type b dissection was then observed at the distal edge of the stent.The patient experienced slow flow, changes in ecg and chest pain.The dissection was covered with a 2.75 x 12 mm drug eluting stent and the procedure was completed.The patient was stable and fully recovered.

• 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: 18829474
• MDR Text Key: 336811117
• Report Number: 2124215-2024-13068
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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: 0030707172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: Asian