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

Model Number 9543

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

Patient Problems Angina (1710); Reocclusion (1985)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) study.It was reported that in-stent restenosis had occurred.In (b)(6) 2013, the patient presented with unstable angina.Prior to procedure, the subject was found to have an abnormal stress test indicative of ischemia and the subject was referred for angiography followed by cardiac catheterization.The target lesion was located in distal left circumflex with 80% stenosis and was 20 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00 x 28 mm study stent following post-dilatation, residual stenosis was 0%.The subject was discharged on dual antiplatelet therapy.In (b)(6) 2017 the subject visited for a follow-up and it was noted they had shortness of breath quite often.The subject was referred for nuclear stress test and cardiac catheterization for further evaluation and management.In (b)(6) 2017, follow-up angiography noted the presence of in-stent restenosis.The 100% stenosis in the left circumflex was treated with pre-dilatation and the placement of a 3.0 x 38 mm drug eluting stent.Following post-dilatation, residual stenosis was 0% and the subject was discharged on dual antiplatelet therapy.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8019583
• MDR Text Key: 125499747
• Report Number: 2134265-2018-62394
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2013
• Device Model Number: 9543
• Device Catalogue Number: 9543
• Device Lot Number: 15690418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• 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
• Patient Age: 54 YR