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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Obstruction/Occlusion (2422)

Event Date 07/09/2020

Event Type  Injury  

Event Description

It was reported that no flow and chest pain occurred.The target lesion was located in a tortuous and moderately calcified left anterior descending artery.The lesion was pre-dilated and a guide extension catheter was used for stent delivery.A 2.50 x 38mm synergy xd drug-eluting stent (des) was deployed distally in the lesion with no issues reported.A 3.00 x 20mm synergy xd des was positioned proximal to the implanted stent, but when pressure was applied to the balloon, expansion occurred only in the front of the balloon.No flow and chest pain then occurred.Upon removal of the 3.00 x 20mm synergy xd, the shaft broke outside the patient.The procedure was completed with another device.

• Brand Name: SYNERGY XD
• 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: 10353219
• MDR Text Key: 201730928
• Report Number: 2134265-2020-10307
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention