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

Model Number 10619

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.Vascular access was obtained via the left artery.The 84% stenosed, 3mmx17mm, eccentric, de novo target lesion containing a <=45 degrees bend was located in the mildly tortuous, and severely calcified left anterior descending artery.After a 7f non-boston scientific (bsc) guide catheter, and a 0.14 non-bsc guide wire crossed the lesion, pre-dilation was performed with 3.0x20 emerge balloon catheter resulting to 48% residual stenosis.Following pre-dilation, a 3.00 x 20 synergy drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent could not cross the lesion and when removed, the tip of the stent itself was found to be deformed.The procedure was completed with another of the same device.There were no patient complications reported, and the patient's 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: 10687346
• MDR Text Key: 211672013
• Report Number: 2134265-2020-14304
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2022
• Device Model Number: 10619
• Device Catalogue Number: 10619
• Device Lot Number: 0025027309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• 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 Age: 70 YR