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

Model Number 10632

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2021

Event Type  Injury  

Event Description

It was reported that removal difficulties were encountered.A percutaneous coronary intervention was being performed.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.The lesion was predilated with a 2mm balloon.A 2.50x48mm synergy drug-eluting stent was advanced for treatment.When the stent was deployed at 16 atmospheres for 10-15 seconds, the balloon was unable to remove.It was inflated again but the balloon ruptured.The balloon was cut and a non-boston scientific guide extension catheter was placed over to capture.The device was removed with no fragments left in the patient's body.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that removal difficulties were encountered.A percutaneous coronary intervention was being performed.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.The lesion was predilated with a 2mm balloon.A 2.50x48mm synergy drug-eluting stent was advanced for treatment.When the stent was deployed at 16 atmospheres for 10-15 seconds, the balloon was unable to remove.It was inflated again but the balloon ruptured.The balloon was cut and a non-boston scientific guide extension catheter was placed over to capture.The device was removed with no fragments left in the patient's body.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the balloon ruptured during first inflation at 16 atmospheres.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11672229
• MDR Text Key: 245601259
• Report Number: 2134265-2021-04907
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2022
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0026282891
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention