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

Model Number 10623

Event Date 09/04/2020

Event Type  malfunction  

Event Description

It was reported that stent moved on balloon occurred.Vascular access was obtained via the radial artery.The 80% stenosed, 2.5mmx38mm, eccentric, de novo target lesion with a bend of <=45 degrees was located in the mildly calcified proximal to mid right coronary artery.After the lesion was pre-dilated with 2.5x20 maverick balloon catheter, a 2.50 x 38 synergy drug-eluting stent was selected for use.During preparation of the device, it was noted that the stent had moved on the balloon but was still within the balloon area.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.

• 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: 10603319
• MDR Text Key: 209169623
• Report Number: 2134265-2020-12473
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2021
• Device Model Number: 10623
• Device Catalogue Number: 10623
• Device Lot Number: 0024204202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial