MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10632

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 02/04/2024

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The 80% stenosed and mildly tortuous target lesion was located in the left anterior descending artery (lad).The lesion was pre-dilated with a 2.00 x 12 mm semi-compliant balloon after deploying a 2.50 x 48 mm synergy stent at 12atm, a proximal edge type b dissection was noted.The patient experienced slow flow and chest pain.Changes in ecg were noted.A 2.50 x 15 mm non-compliant balloon was used to post dilate the stent.The dissection was covered with another 2.75 x 12 mm drug eluting stent (des), and the procedure was completed successfully.The patient fully recovered and was stable post procedure.

Manufacturer Narrative

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

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 18779450
• MDR Text Key: 336234532
• Report Number: 2124215-2024-11203
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0030801082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• 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): Required Intervention
• Patient Sex: Male
• Patient Race: Asian