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 Hematoma (1884); Vascular Dissection (3160)

Event Date 12/16/2023

Event Type  Injury  

Manufacturer Narrative

E1 initial reporter address 2: (b)(6).

Event Description

It was reported that a dissection and hematoma occurred.The 90% stenosed target lesion was located in the moderately tortuous right coronary artery (rca).The lesion was pre-dilated using a 3.00 x 12mm non-compliant balloon.After deployment of a 3.50 x 48mm synergy drug-eluting stent (des) at 14atm, type b dissection and hematoma was noted at the distal of the vessel.Patient experienced reduced blood flow.Stent was dilated with 3.50x12 and 4x12 balloons during final dilation.An additional des was used in the hematoma to regenerate the flow and to cover the dissection.The procedure was completed successfully, and the patient fully recovered.

• 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: 18450731
• MDR Text Key: 332260008
• Report Number: 2124215-2023-74243
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0031132929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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): Required Intervention
• Patient Race: Asian