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

Model Number 10619

Device Problem Fracture (1260)

Patient Problem Ischemia (1942)

Event Date 12/23/2021

Event Type  Injury  

Event Description

It was reported that slow flow occurred. The target lesion was located in the calcified left main (lm) to left anterior descending artery (lad). Following predilatation, a 3. 50 x 20 synergy stent was deployed at nominal pressure. The lesion was post dilated with a 4 x 8mm balloon, and with a proximal optimisation technique (pot) in the lm at nominal 12 atmospheres, but slow flow and a fracture in the proximal end of the stent was noted. Another stent was deployed to cover the fracture. Post stent deployment, the flow was good. Post dilatation was performed with a 4 x 8mm balloon, and the procedure was completed. No further patient complications resulted in relation to this event, and the patient was reported to be good and stable post procedure.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13184788
• MDR Text Key: 283394992
• Report Number: 2134265-2021-16537
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0027665042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/06/2022 Patient Sequence Number: 1