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

Model Number H7493919920300

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Reocclusion (1985)

Event Date 02/09/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

(b)(6) clinical study.It was reported that unstable angina and in-stent restenosis occurred.In (b)(6) 2013 the subject presented with stable angina (ccs classification: 2) and was referred for cardiac catheterization.Target lesion #1 was located in the proximal left anterior descending artery (lad) with 80% stenosis and was 16 mm long with a reference vessel diameter of 3.0 mm.Target lesion #1 was treated with pre-dilatation and placement of 3.00 x 20 mm study stent with 0% residual stenosis.In (b)(6) 2013, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2018, 1715 the subject was admitted due to recurrent chest pain and syncope.The subject also stated that he had frequent episodes of palpitation and nausea.The subject¿s symptoms were assessed as unstable angina with ccs iii.On admission, electrocardiogram (ecg) revealed deep t wave inversion in the precordial leads (v2-v6) and these changes were new.Cardiac markers were normal.The subject was referred for coronary angiography for further evaluation.The 90% in-stent restenosis in proximal lad was treated with the placement of a 3.0 x 12 mm synergy¿ stent with 0% residual stenosis and timi 3 flow.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7664510
• MDR Text Key: 113257586
• Report Number: 2134265-2018-05896
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2013
• Device Model Number: H7493919920300
• Device Lot Number: 15671416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR