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 Congestive Heart Failure (1783); Death (1802)

Event Date 01/02/2018

Event Type  Death  

Event Description

(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, the subject presented with stable angina (ccs classification- 2).Prior to the procedure, the subject was found to have abnormal stress test or imaging stress test indicative of ischemia and the subject was referred for cardiac catheterization.Target lesion #1 was located in the ramus with 90% stenosis and was 22 mm long with a reference vessel diameter of 2.5 mm.Target lesion #1 was treated with pre-dilatation and placement of a 2.50 x 28 mm study stent.Following post dilatation, residual stenosis was noted to be 0%.The following day, the subject was discharged on dual antiplatelet therapy.In (b)(6) 2014, the patient presented with unstable angina.Rotational atherectomy was performed and two promus premier stents were implanted in the proximal to mid left anterior descending artery.In (b)(6) 2018, the subject was diagnosed with congestive heart failure and on the same day the subject died.The cause of death was due to heart failure.

• 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: 7837586
• MDR Text Key: 118915135
• Report Number: 2134265-2018-60509
• 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: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• Device Model Number: 9543
• Device Catalogue Number: 9543
• Device Lot Number: 15687353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2012
• 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 Outcome(s): Death
• Patient Age: 83 YR